RTOG: Subcommittee Minutes - Outcomes & Health Services Research

Subcommittee Minutes - Outcomes & Health Services Research

OUTCOMES AND HEALTH SERVICES RESEARCH COMMITTEE (January 2008)

Deborah Bruner, Ph.D., Chair

Announcements

Dr. Bruner announced the RTOG Core Grant will be submitted February 1, 2008 and the site visit has been scheduled for July 15, 2008 at the National Cancer Institute (NCI).

The NCI has announced a special funding opportunity for symptom management or quality of life correlative studies. The applications are due in March. The Outcomes and Health Services Research Committee will submit an application on fatigue and list Dr. Andrea Barsevick as the Principal Investigator.

NCI Clinical Trials Infrastructure Restructuring.

Dr. Bruner presented on the implementation of the NCI Clinical Trials Working Group recommendations. The roles and goals of the Clinical Trials Advisory Committee, Disease Site, and Symptom Management and Health Related Quality of Life Steering Committees were discussed. All concepts from other cooperative groups and CCOP's are symptom management trials or other trials have patient reported outcomes or quality of life as the primary endpoint will be reviewed by the Symptom Management Committee as well as Division of Cancer Prevention.

Developing Concepts - The following developing concepts were reviewed:

RTOG 0614- WBRT +/- Namenda versus placebo for prevention of cognitive dysfunction.

RTOG 0616- Tadalafil to prevent ED (Bruner) working with Lilly on funding

RTOG 0631- Stereotactic radiosurgery for spine mets (Ryu)

RTOG 0537- Electroacustim/Pilocarpine for Xerostomia (Wong) - funding for acustim has been obtained

RTOG 0634- Anaplastic Glioma

RTOG 0825- GBM, TMZ & Bev

RTOG 0811- Radiation Therapy (IMRT) +/- Cetuximab for Intermediate Risk Resected H&N (Machtay)

RTOG 0436- Esophogeal Chemotherapy RT (Suntha)

RTOG 0714- Resectable Pancreas IMRT + 5FU/Gem + erlot (Abrams)

RTOG 0534- Whole Pelvis versus Prostate Bed in High Risk Prostate Cancer (Pollack), to open in February 2008

RTOG 0815- High dose versus pelvic RT for low-intermediate risk Prostate Cancer (Martinez) - will focus on a fatigue endpoint

RTOG 0724- Concurrent Chemo + Pelvic RT versus Concurrent Chemo + Pelvic RT + Adjuvant Chemo in Pts w + Nodes and/or + Margins for Cervical Cancer Post Radiation Hysterectomy (Jhingran)

RTOG 0630- Sarcoma (Wang)

RTOG 0713- IMRT in Breast (Vicini), needs QOL component

New Concepts

Depression Concept (Coyne) - Sites would use PRO to screen for depression and those above specific cutoff would receive telephone screening and interview by trained staff. Funding may be an issue, although DCP is interested, as little data on depression. HSRO supportive of the protocol pending funding.

Modafanil concept (Movsas) - "Fatigue" should be defined. Assessment tools are available-Dr. Cella's PROMISE and the BFI. HSRO approves concept development.

Proton registry study (Konski) - Is this an equivalency study? Primary outcome would be QOL. Needs CCOP approval. HSRO recommends this for R01 or equivalent funding application and consider using the RTOG for accrual.

QOL Report - Dr. Movsas reported the QOL Instrument Library, coordinated by Dr. Dilling is available on the RTOG website.

CTER Working Group - Dr. Sun reported on plans to develop a "Feasibility Review Committee" comprised of radiation oncologists, research associates and patient advocates. Feasibility review will be conducted for developing Phase III trials to recommend improvements in logistical issues may impact patient recruitment.

Special Populations - No report.

Economic Impact Report - No report

Mr. Martin Pellinat, Chief Executive Officer Vision Tree Software, Inc. presented on the software application for the new protocol, "Pilot Project to Reduce Missing RTOG Quality of Life Data via Electronic Web-based Form Collection: a companion study for RTOG 0415" - Benjamin Movsas, MD is the Principal Investigator.

OUTCOMES AND HEALTH SERVICES RESEARCH COMMITTEE (June 2007)

Deborah Bruner, Ph.D., Chair, Outcomes Committee
Benjamin Movsas, MD, Chair, QOL Subcommittee

Announcements - Dr. Bruner announced the Core Grant is due to headquarters this summer and she will need updates from the liaisons.

Developing Concepts - The following developing concepts were reviewed:

RTOG 0614 WBRT +/- Namenda for Cognitive Fx (Brown)

RTOG 0631 Stereotactic radiosurgery for spine mets (Ryu)

RTOG 0537 Electroacustim/Pilocarpine for Xerostomia (Wong)

RTOG 0527 Concurrent chemo RT for Loc Adv Panc (Crane)

RTOG 0534 Whole Pelvis vs. Prostate Bed in High Risk Prostate Cancer (Pollack)

RTOG 0616 Sildenafil to prevent ED (Bruner)

QOL Report - Dr. Movsas reported the QOL Instrument Library is making progress under the leadership of Dr. Tom Dilling. There are approximately a dozen QOL instruments that are ready to be placed on the RTOG website. RTOG headquarters will need to preview with legal the appropriate wording for a disclaimer (instructing readers to check for the latest updates of these instruments and for copyright issues, etc.). This instrument library will grow and evolve over time and members of the Outcomes Committee will be asked to contribute. Dr. Movsas announced the goal to incorporate Dr. David Cella's short PROMIS forms into an RTOG Study. The plan is to work together with Dr. Lisa Kachnic to incorporate this into one of the upcoming randomized pancreatic cancer studies (using the short fatigue scale).

One goal is to have an Outcomes/QOL Study presented to the RAs at each meeting. Darlene Johnson is the Outcomes RA Liaison who will work with the RA Educational Committee towards this goal.

Deborah Citrin is the liaison from the Translational Research Committee to the Outcomes Committee. She is available to help guide people through this process.

The priority list for Outcomes/QOL Projects/Analyses was reviewed at the Outcomes Steering Meeting yesterday. These projects include the analyses funded through the Pennsylvania Tobacco Grant, including the analysis related to race vs. gender vs. martial status and the analysis related to missing QOL. Dr. Movsas has recently submitted a secondary analysis request to study a new methodology for toxicity reporting (TAME) in lung cancer.

Dr. Movsas also mentioned RTOG is working on plans for a pilot study of a software program that allows for real-time completion of the QOL forms on a secure website. The purpose of this pilot will be to see if this technology, which also allows for email reminders real-time to both the patients and RAs, will enhance compliance with Outcomes/QOL.

CTER Working Group - Dr. Sun and Dr. Walker reviewed the recent efforts of the CTER working group. There are various trials having accrual problems especially some of the CCOP studies. There was a special program over a luncheon for RTOG 0517 and RTOG 0518 which went well.

Special Populations - Dr. Roach reported a special task force will be set up in the near future to study special population issues, particularly as they relate to the elderly. This also needs to include some measure of comorbidities. Other people involved in this project will include Dr. Ben Corn, Dr. Corey Langer, and several experts on this issue from Moffitt Cancer Center.

Economic Impact Report - Dr. Konski updated the Outcomes Committee on recent economic analyses. He also gave a presentation entitled "The Addition of Chemotherapy to Radiation Is Cost-Effective in the Treatment of Patients with Locally Advanced Laryngeal Cancer: An Economic Analysis of RTOG 9111."

Publications Update - Dr. Movsas reported his paper studying QOL as a pre-treatment for prognostic factor in head and neck cancer has been accepted to the Red Journal. His RTOG 9801 QOL analysis (with Linda Sarna) has been written and will be submitted shortly. The RTOG 9801 analysis showing QOL is the most important prognostic factor for outcome was accepted as an oral presentation to ASTRO. The paper he worked on with Dr. Corn (as first author) on the analysis of Quality of Life in the thalidomide brain metastasis trial has been submitted to the Red Journal (with the primary paper). Dr. Jim Coyne's paper on emotional well-being for head and neck cancer has been accepted in Cancer. Dr. Bruner reported RTOG 9714 utilities paper has been submitted to Medical Decision Making. She is currently working on the manuscript for RTOG 0215 and the abstract for this has been accepted as an oral presentation at ASTRO. Dr. Walker is close to completing the recruitment survey paper. The RTOG 0315 QOL abstract has been submitted to ISOQOL.

OUTCOMES COMMITTEE (February 2007)

Deborah W. Bruner, Ph.D., Chair

I. Announcements/Updates

The RTOG competing renewal grant is due on February 1, 2008.

II. Closed Protocols Since Last Meeting

RTOG 0421 - A Phase III Trial for locally recurrent, previously irradiated Head and Neck Cancer using concurrent re-irradiation and chemotherapy versus chemotherapy alone was closed on 1/5/06 due to poor accrual.

III. Open Protocols

RTOG 0517-Dr. Michael Seider is the Principal Investigator on this Phase III multimodality study using Bishophnates + Samarian or Strontinum for bone mets which opened on July 11, 2006.

RTOG 0435 - A Phase III cancer control head & neck study using KGF for mucositis.

IV. Developing Concepts

RTOG 0614- Drs. Brown and Fox are the study chairs for this concept which was approved on 12/4/06 using WBRT +/- namenda for Cognitive Function.

RTOG 0631-Dr. Janice Ryu is the study chair for this protocol study using stereotactic radiosurgery for spine mets where the endpoints are yet to be determined.

RTOG 0537-This concept was approved in October, 2006 but the study chair will need to find funding. This study will be using Electroacustim/Pilocarpine for Xerotomia.

RTOG 0436-Drs. Mohan Suntharalingam and Lisa Kachnic will be study chairs for this concept using esophageal chemotherapy RT where the QOL endpoint was taken out and now put back in the protocol which will be submitted to CTEP.

RTOG 0527-The original concept using concurrent chemotherapy radiation therapy for local advance prostate cancer was not approved. The concept is being revised and will be resubmitted.

RTOG 0534-This study using whole pelvis versus prostate bed in high risk prostate cancer is currently at CTEP being reviewed.

RTOG 0616-This will be an intergroup study with Fox Chase Cancer Center CCOP Research Base. This protocol using Sildenafil to prevent ED has been approved by DCP and is awaiting full protocol approval.

RTOG 0626-Dr. Jim Talcot reported on the proton study where QOL will be the primary endpoint and has limited participation to four sites with protons.

RTOG 0630 - This sarcoma study is currently at RTOG Headquarters and needs sample size review.

V. QOL Report-Benjamin Movsas, M.D.

Dr. David Cella, Guest Speaker spoke about PROMIS and further information is available on nihpromis.org web site. The RTOG outcomes group will consider appropriate trials to pilot.

VI. CTER Working Group-Eleanor Walker, M.D.

The Symposium on "Benchmarking Your RTOG Accrual: Where Your Institution Stands & Strategies for Improvement" which was held at the RTOG meeting in February was well attended. The studies which CTER is consulting on include RTOG 0214 the PCI study, & RTOG 0232 the prostate brachytherapy study done in consult in 2006 was revisited at this meeting. If DMC permits the study to remain open CTER will consider development of a patient education DVD. Other studies include RTOG 0421 the head & neck cancer re-irradiation study, RTOG 0517 the palliation of bone mets study & RTOG 0518 the prevention of osteoporosis after hormones for prostate cancer. CTER will receive support from Novartis will develop patient education DVD for this and RTOG 0517 and will have a kick off luncheon for both studies at the next RTOG Semi-Annual Meeting.

VII. Special Populations-Mack Roach, M.D. (No Report)

VIII. Economic Impact Report-Andre Konski, M.D.

Dr. Konski reported an economic analysis which was funded by the Pennsylvania Tobacco Settlement Funds to be presented at the Publications Committee meeting.

IX. RTOG New Conceptual Framework-Drs. Movsas and Deasy

RTOG has a new conceptual framework combining imaging and QOL endpoints which were presented by Drs. Movsas and Deasy on RTOG 0617 the high dose 3D-CRT study demonstrating how the evolving outcomes framework is guiding the incorporation of complimentary endpoints including PROs, biomarkers and imaging.

OUTCOMES COMMITTEE (June 2006)

Benjamin Movsas, M.D., for
Deborah W. Bruner, Ph.D., Chair

Closed Protocols

Open Protocols

Since Last Meeting

Opened Protocols

Developing Concepts

Recruitment & Outreach Working Group

Special Populations Reports

Economic Impact Report

QOL Report

Announcements/Updates

Patient Reported Outcomes (PRO)

OUTCOMES COMMITTEE (January 2006)

Deborah W. Bruner, Ph.D., Chair

Open Protocols Issues

RTOG 0215 - The RTOG study using Sildenafil is currently under review by DSM for slow accrual.

RTOG 0235 - Brachytherapy versus brachytherapy + EBRT. The recruitment survey has helped identified barriers to recruitment but the solutions presented are difficult.

RTOG 0412 - A Phase III preoperative chemotherapy versus preoperative chemotherapy and concurrent radiation therapy followed by surgical resection and chemotherapy in stage IIIA non small cell lung cancer. This study is having recruitment issues and will be referred to the Recruitment Working Group. Both Drs. Movsas and Werner-Wasik presented this study to the Research Associates Committee.

RTOG 0421 - A Phase III concurrent re-irradiation and chemotherapy versus chemotherapy alone for locally recurrent previously irradiated head and neck cancer. The study is having recruitment issues and will be referred to the Recruitment Working Group.

Developing Concepts

RTOG 0431 - A developing concept using hormones and AMG 126 monoclonal antibodies to reduce skeletal events (osteoporosis and mets) after PrCa radiation therapy. Dr. Roach and RTOG Headquarters are negotiating with Pharma.

RTOG 0435 - A phase II dose seeking trial using KGF for radiation mucositis. The instruments involved with this study are WHO & RTOG toxicity, BPI, MDASI waiting on CTEP drug distribution approval.

RTOG 0436 - A phase III esophagus study using FACT - E and Eq5D, will revise time points and we will add rationale for collection of long term data for prospective assessment of survivorship issues. This rationale is to serve as a template for other studies.

RTOG 0518 - A developing concept for risk of osteoporosis and fractures in patients treated for Adeno of the prostate with radiation therapy and hormonal manipulation. The protocol was initially reviewed by DCP and approved with revisions in progress. For the first time we are coordinating three bone event studies with respect to measures and time points to prospectively plan for future metanalysis.

RTOG 0517 - A developing study using Bisphosphnates and Samarian or Strontium for bone mets. The concept went to DCP in January. The osteoporosis measure is being modified with a collaboration instrument developed to use on RTOG 0518, 0517 and 0431

RTOG 0527 - A phase III pancreas study using FACT - Hep and Eq5D and we will revise time points. We will add rationale for collection of long term data for prospective assessment of survivorship issues.

RTOG 0528 - A developing concept using Calendula ointment for breast radiation therapy dermatitis. Clement Gwede will take over as QOL chair in Deb Bruner's place. Dr. Lawrence Berk and RTOG Headquarters are negotiating with Pharma.

RTOG 0534 - A phase III post operative prostate study with three arms. This study will use instruments EPIC, HVLT & COWAT, it will measure serum Abeta as marker for cognitive dysfunction. The study has been approved by CTEP with revisions in progress.

A developing phase III Namenda study for cognitive dysfunction prevention after radiation therapy will use RTOG neurocognitive battery and FACT brain.

Proposed Concepts

Dr. Berk has two proposed CCOP studies. One is a dose escalation study for cord compression with primary endpoints being ambulation and pain. We need to add BPI and measure pain and narcotic use as in RTOG 9714. The second study is a raspberry paste for prevent of a second malignancy.

Dr. Ryu has a phase II spinal cord radiosurgery concept which was presented to the CNS Committee to measure BPI and narcotic use as per RTOG 9714.

Recruitment Working Group

The preliminary results of selected questions were discussed and the survey has begun to identify issues for which we can develop strategies to try and improve recruitment. Dr. Gore's PCI study will be first test case. The survey was distributed at RTOG meeting to increase response.

Economic Impact Report

The work being funded through the Tobacco funds are in progress. Dr. Konski is developing hypothesis for follow up to economic findings. The Sandostatin study is about to close and it has an economic component. The grant for economic analysis of RTOG 9714 is not funded and there will be no economic analysis. There are multiple developing studies now have EQ5D which could lead to future economic analyses given additional funding, we need to be sure we add to the protocol the consent rationale for obtaining social security numbers which link to Medicare data.

Quality of Life Report

The pretreatment quality of life paper by Dr. Benjamin Movsas has been accepted to IJROBP. We are awaiting QOL marker statistics analysis in head and neck cancer which has been approved for a secondary analysis. There will be a QOL presentation at the Research Associates Committee meeting.

Normal Tissue Complication Probability Modeling

Dr. Joe Deasy presented model for pneumonitis. Drs. Bruner, Konski, Movsas and Deasy will discuss potential for future collaborations incorporating patient outcomes in the model.

Outcomes & Health Services Research Committee Core Grant Renewal

The first draft for the RTOG grant renewal is due in May. Dr. Bruner presented how we have met specific aims thus far. For the grant we will maintain all but the EPI aim. A new aim will be the collaboration with the TRP Committee to assess markers of toxicity and QOL.

OUTCOMES COMMITTEE (June 2005)

Deborah W. Bruner, Ph.D., Chair

Topic	Reporting	Action/Issue
I. Announcements/Updates	Bruner	• An Outcomes Retreat was held in April to assess how well we are meeting goals and plans for the future, we now have multiple studies assessing the RTOG Outcomes Triad. • Due to expanding role we will change name of this committee to Outcomes and Health Services Research Committee.
II. Closed Protocols Since Last Meeting		RTOG 0219 met accrual.
III. Open Protocols
A. Since Last Meeting	Movsas
RTOG 0421 Ph III Concurrent Re-Irradiation + Chemo Vs Chemo Alone For Locally Recurrent, Previously Irradiated H&N Cancer.
RTOG 0412 Ph III Preop Chemo vs Preop Chemo+ concurrent RT followed by surgical resection and chemo in Stage IIIA NSCLC.
B. Open Protocol Issues
Accrual/Compliance	Bruner	Encourage special attention to these protocols.
RTOG 0232 Brachytherapy vs Brachytherapy +EBRT		An accreditation issue appears to be major barrier.
RTOG 0214 PCI NSCLC		Barrier unclear.
RTOG 0215 Sildenafil for prostate ED		Amendment to open eligibility to pts not on RTOG 9910 approved 3/05.
RTOG 0123 Captopril for lung sequallae
IV. Developing Concepts – in order of CCOP priority	Kachnic
1) RTOG 0517 Bisphosphnates + Samarian or Strontinum for bone mets		We are working to coordinate endpoint definitions related to skeletal events and measures, where possible, across the 3 studies. Will probably use FACT G in all 3 studies and a measure of osteoporosis in RTOG 0518 & 0431.
2) RTOG 0518 Risk of Osteoporosis & Fractures in Pts Treated for PrCa With RT + Hormones
4) RTOG 0431 Hormones + AMG 126 monoclonal antibody to reduce skeletal events (osteoporosis & mets) after PrCa RT
3) RTOG 0435 KGF for radiation mucositis, Ph II doses seeking trial		Will use common measures including FACT and BPI. Both protocols have been drafted.
7) RTOG 0419 Gelclair for radiation mucositis, Ph III for post op H&N
5) RTOG 0326 Ph III Ginseng for Radiation-Induced Fatigue
6) Calendula for breast skin care
V. Proposed Concepts
Erectile dysfunction prevention trial	Bruner	Possible intergroup with Fox Chase Cancer Center.
Depression concept	Coyne/Wheeler	Draft in progress.
Efficacy And Safety Of Memantine In Brain Irradiated Ps With Cognitive Dysfunction:	Fox	Considering neurocognitive battery.
VI. Recruitment & Outreach Working Group	Bruner/Walker	New working group presented with the purpose of increasing recruitment to clinical trials. Members needed and we are looking for diverse ethnic representation including Asian and Latino RTOG members. Contact Deb Bruner if interested.
VII. Special Populations Report	Roach	• Minority issues identified in Recruitment Working Grp will receive further consideration and generate possible research studies in the Special Population Committee. • Forming relationships with the NCI Radiation Health Disparities Group; Drs. Bruner, Roach & Walker met with group here at RTOG to discuss opportunities for collaboration.
VIII. Economic Impact Report	Konski	• RTOG 0232, 0315, 0320, 0421 have economic endpoints; RTOG 0523 in development has economic endpoint. • R21 for economic analysis of RTOG 9714 submitted for 3rd time. • Tobacco Funds supported economic analysis of smoking related tumors awaiting Medicare data tapes.
IX. QOL Report	Movsas	• MS on pretx Qol of multiple sites submitted to Red Journal 6/05. • Movsas/Bruner/Pajak will begin to explore correlations among QOL and markers. • Plan to begin to assess symptom clusters. • Dr. O’Mara to present at Jan ’06 mtg for update of special NCI/cooperative group meeting on QOL in the fall ’05.
X. Epi Task Force to Revise A5	Bob Chamberlain	Zip code analysis confirms data to be unreliable in predicting income; suggestion has been made to use geocoding in the future.
XI. Presentation of new MDAnderson instrument to measure symptom burden in brain cancer patients.	Terry Armstrong	• Instrument being considered for upcoming brain trials. • Issue of symptom burden/clinical benefit vs QOL raised, discussion needs to continue at future meeting.
XII. Outcomes Presentation ASCO 05 abstract: Breast Cancer Pts have Better Outcomes Than Prostate Cancer Pts Treated with either 8 Gy in 1 fx or 30 Gy in 10 fxs for palliation of painful bone mets: Results of RTOG 9714.	William Hartsell, MD

OUTCOMES COMMITTEE (January, 2005)

Deborah W. Bruner, Ph.D., Chair

Topic	Outcome Measures	Action/Issue
I. Closed Protocols Since Last Meeting
RTOG 0118 Thalidomide Closed 7/04		Abstract submitted to ASCO
II. Open Protocols
A. Since Last Meeting
RTOG 0320, Phase III, Whole Brain RT +Stereotactic Radiosurgery Alone vs with Temozolomide (Temodar) vs With Zd1839 (Iressa) Opened 10/04		Currently closed due to new data on Iressa, amendment pending, considering reopening as Phase II
B. Open Protocol Issues
RTOG 0215 Phase III Sildenafil for PrCa erectile dysfunction	IIEF, SAQ,Locke’s Marital Adjustment	Activated 1/3/03; accrual 85/332; amendment to open eligibility to similar patient population but not on RTOG 9910 sent to DMC
III. Developing Concepts
RTOG 0522 Phase III Concurrent Accelerated RT + Chemo Vs Concurrent Accelerated RT, Chemo, and Cetuximab (C225) For Stage III and IV H&N Cancer	PSS-HN, HNRQ	Consider adding EQ5D
RTOG 0421 Phase III Concurrent Re-Irradiation + Chemo Vs Chemo Alone For Locally Recurrent, Previously Irradiated H&N Cancer	PSS-HN, HNRQ other QOL instruments to be determined	Consider adding EQ5D
RTOG 0326 Phase III Ginseng for Radiation-Induced Fatigue	Schwartz Brief Fatigue Inventory, Spitzer Quality of Life Index (SQLI)	Pharmacon will provide drug & placebo but we need $80K for drug distribution, NCI & OCAM have turned down request for funding, will consider submission for R01
RTOG 0218 Risk of Osteoporosis & Fractures in Patients Treated for Adeno of the Prostate With RT+ Hormonal Manipulation	FACT-GOsteoporosis Index	Approved by DCP as Phase III (was submitted as a Phase II); will consider adding utilities & C-E
RTOG 0435 KGF for radiation mucositis, Phase I-II doses seeking trial	Mucositis, BPI	Concept approved by DCP; will consider adding utilities & C-E
Gelclair for radiation mucositis, Phase III for post op H&N	BPI, Mucositis	Concept approved by DCP
RTOG 0433 NCIC Reirradiation for bone mets	BPI	Concept approved
RTOG 0431 AMG 126 monoclonal antibody	Skeletal events, prevention of osteoporosis	Statistics to complete sample size and analysis plan and will be sent to DCP before next meeting
IV. Proposed Concepts
Erectile Dysfunction Prevention Trial	IIEF, SAQ,Locke’s Marital Adjustment	Schema complicated, will discuss with GU Cancer Committee
Bisphosphonates + Samarian or Strontium for bone mets		Need to consider use of BPI
Dutasteride	AUA symptom score, prevention of rise in PSA	Consider stratification by TX and using EPIC
Calendula ointment for breast RT dermatitis	Needs to be determined	Additional concept for use of Ray Gel presented at Symptom Management Committee will considering combining for a 3 arm study
	Reporting
V. Special Populations Report		No report
VI. Economic Impact Report	Dr. Konski
RTOG 9714 closed		2 abstracts on utilities, one ms in progress
R21 for C-E of RTOG 9714		To be resubmitted for 3rd and final time in March
PA Tobacco Funds –C-E analysis of H&N trials		Medicare data has been requested for C-E analysis
VII. QOL Report	Dr. Movsas
New QOL Liaison to the Brain Tumor Committee		Dr. Sherry Fox appointed
Policy on QOL instrument translations developed: If QOL is not primary endpoint & pt speaks language other than those available in QOL instrument, pt will be eligible for primary endpoint but excluded from QOL endpoint (we expect this to be about 5% of patients); if QOL is primary endpoint and & pt speaks language other than those available in QOL instrument, pt will be ineligible		Policy to be available at HQ and distributed among QOL & Outcomes Comm.
VIII. PA Tobacco Settlement Funds - Lung	Dr. Movsas	Analysis in progress with 1,500 patients, predictors of outcomes different that what was found in H&N analysis
IX. Outcomes presentations/publications
Zip code analysis	Dr. Chamberlain	1^st draft of MS almost complete, RTOG patients appear to consistently under-report income, recommendations on how to account for this in future analyses will be made
X. Other
A5 sociodemographic form	Dr. Bruner	Last revised 8 years ago, Dr. Chamberlain to chair a task force to review, will reconsider ethnic, income categories and consider revised smoking and comorbidity categories

OUTCOMES COMMITTEE (June, 2004)

Deborah W. Bruner, Ph.D., Chair

I. Open Protocols	Outcome Measures	Action/Issue
RTOG 0247 Randomized Phase II Neoadjuvant Combined Modality Therapy For Locally Advanced Rectal Cancer	EORTC QLQ-C30; EORTC QLQ-CR 38; Sexual Adjustment Questionnaire (SAQ)	Activated 3/15/04
RTOG 0123 Phase II Captopril for lung sequelae	EORTC QLQ-C30 and QLQ-L13; LENT scales & biochem markers	Activated 6/4/03; accrual poor, 9/205; amendments made to improve accrual
RTOG 0213 Phase I/II Celebrex for LA-NSCLC	Zubrod, ADL, GDS IAD, LCSS, SCFS, MMSE	Activated 7/30/02; accrual 13/122
RTOG 0214 Phase III PCI for NSCLC	EORTC QLQ C30 BCM20; MMSE, ADL	Activated 9/19/02; accrual 63/1058
RTOG 0216 Phase III 3D prostate	IIEF, FACE, SQLI	Activated 3/21/02; accrual 294/1520
RTOG 0232 Phase III Brachy vs brachy + EBRT	EPIC and EQ5D, & collect costs at select sites	Activated 6/11/03; accrual 41/1520
RTOG 0122 Phase III Juven for cancer cachexia	SCSF, SQLI, Bioimped	Activated 12/6/02; accrual 355/468
RTOG 0215 Phase III Sildenafil for PrCa erectile dysfunction	IIEF, SAQ, Locke’s Marital Adjustment	Activated 1/3/03; accrual 66/332
RTOG 0315 Sandostatin to prevent chemo RT diarrhea	QOL-RTI, FACE EPIC-Bowel, CTC diarrhea scale C-E analysis	Activated 12/5/03; accrual 29/226
II. Developing Concepts
RTOG 0320, Phase III, Whole Brain RT +Stereotactic Radiosx Alone vs + Temozolamide vs + Iressa	EQ5D; FACTB +L, QAS secondary endpoint	Just returned from CIRB
RTOG 0326 Phase III Ginseng for Radiation-Induced Fatigue	Schwartz Brief Fatigue Inventory, Spitzer Quality of Life Index (SQLI) and POMS	Plan to have open by next RTOG meeting
RTOG 0218 Risk of Osteoporosis & Fractures in Pts Treated for Adeno of the Prostate With RT+ Hormonal Manipulation		Concept for observational study rejected by NCI, suggest trial go directly to intervention
III. Proposed Concepts
KGF for radiation mucositis, Phase II doses seeking trial	Mucousitis, BPI	CCOP/Symptom Mgmt Committee high priority
Gelclair for radiation mucositis, Phase III for post op H&N	BPI, Mucousitis	CCOP/Symptom Mgmt Committee high priority
Bisphosphnates + Samarian or Strontinum for bone mets		Still awaiting protocol
AMG 126 monoclonal antibody to reduce skeletal events after PrCa RT	Skeletal events	Has Outcomes Committee, Prostate Committee and Research Strategy Approval
Calendula ointment for breast RT dermatitis	Needs to be determined	Approved by Outcomes and Symptom Management
Concerta for neurocog deficitis after RT	Neurocog battery	Approved by Outcomes and Symptom Management

IV. QOL Report – Dr. Bruner for Dr. Movsas	Recruitment grant on hold	RT Health Disparity grant recipients to be invited to meet with RTOG Special Populations and Outcomes Steering Committee in Jan ’05
V. Economic Impact Report- Dr. Konski	Open studies w Economic endpoints include RTOG 0232 & 0315	Economic analysis of outcomes using Medicare data for tobacco related cancers recently funded by PA Tobacco Settlement Funds; R21 for analysis of RTOG 9714 for 3^rd resubmission
Dr. Chamberlain presented analysis on correlations between census income data and patient reported income data	Correlations are poor and census data cannot serve as a proxy for patient reported data	Further analyses pending; manuscript in preparation
VI. Special Populations Report- Dr. Roach		Special meeting of RT health disparities grant awardees to be set up at next RTOG meeting
VII. PA Tobacco Settlement Funds- for outcomes in special populations	Year 1 Head & Neck study presented at H&N comm. and RTOG Plenary Session	Year 2 lung project in progress; Year 3 will be a prostate project
VIII. Dissemination of Outcomes	MaryLou Smith and Hank Porterfield are assisting Outcomes Committee with dissemination efforts. To date findings of RTOG 9714 have been disseminated via newsletter.	Publication and Outcomes Committee have asked patient advocates to make recommendations for preferred methods of dissemination
IX. Outcomes presentations/publications		Outcomes Research in Cancer Clinical Trials Cooperative Groups: The RTOG Model, Quality of Life Research, 13; 1025-1041:2004

OUTCOMES COMMITTEE (January, 2004)

Deborah Bruner, Ph.D., Chair

I. Open Studies:

RTOG 0215 - Sildanafil for ED (corollary for RTOG 9910) Status: Activated in January 3, 2004, 28/332 accrued, Amendment of eligibility presented by Dr. Bruner. Window of eligibility post treatment on RTOG 9910 changed from minimum of 6 months to maximum of 18 months from end of treatment on RTOG 9910 to minimum of 6 months and maximum of 5 years. Stratification changes include dropping age as stratification variable and adding Sildenafil use since treatment on RTOG 9910 as stratification variable. ACTION: Dr. Roach suggested review of data collected on prior Sildenafil use.

II. Developing Concepts:

RTOG 0320 - Phase III, Three-Arm Trial in Pts With NSCLC and 1-3 Brain Metastases Comparing Whole Brain RT +Stereotactic Radiosurgery Alone vs with Temozolamide (Temodar) vs With Zd1839 (Iressa) (PI Sperduto, Outcomes PI Konski) Outcome measures – EQ5D + C. QAS secondary endpoint Sample size, 381. Status: Revisions sent back to NCI, awaiting re-review.

RTOG 0326 - Phase III trial of Ginseng for Radiation-Induced Fatigue. (PI, Fisher, J; Wyatt added as QOL PI 12/03) Outcome Measures- Schwartz Brief Fatigue Inventory, Spitzer Quality of Life Index (SQLI) and POMS. Sample size, 648. Status: June 03 - NCI required changes. ACTION: Revisions in progress.

RTOG 0247 - Randomized Phase II Trial of Neoadjuvant Combined Modality Therapy For Locally Advanced Rectal Cancer. (PI Meropol; QOL PI, Kachnic, L) Outcome Measures- EORTC QLQ-C30; EORTC QLQ-CR 38 and the Functional Alterations due to changes in Elimination (FACE); Sexual Adjustment Questionnaire (SAQ). Sample size, 106. Status: activation pending final NCI review.

RTOG 0218 - Risk of Osteoporosis and Associated Fractures in Patients Treated for Adenocarcinoma of the Prostate With Radiation Therapy Plus or Minus Hormonal Manipulation (PI, Lawton, QOL PI Wilmoth) ACTION: In development. Guyatt osteoporosis quality of life questionnaire will be used. Dr. Wilmoth added as QOL co-investigator.

III. Proposed Concepts:

CCOP Concepts requiring Outcome collaboration –Dr. Kachnic reported (in order of developing priority) and the following concepts were approved by Outcomes:

a. KFG for radiation mucositis (Rosenthal/Kachnic) ACTION: in development over next 3 months

b. Gelclair for radiation mucositis (Kachnic) ACTION: in development over next 3 months

c. Bisphosphnates + Samarian or Strontinum for bone mets (Sider) for pts with > 2 bone mets, sites to include primary sites to include prostate, breast and lung, primary outcome – pain, ACTION: in development over next 3 months. Dr. Bruner suggested using same measures as used on recently closed Bone Mets trial RTOG 9714. QOL investigator to be assigned and measures need to be determined.

d. AMG 126 monoclonal antibody binds with osteoclast receptor (Roach) for hormone-refractory pr ca ACTION: QOL measure to be considered

e. Acupuncture for xerostomia (Streeter) ACTION: Requires pilot data and feasibility assessment. R21 mechanism suggested. Dr. Streeter to follow-up.

IV. QOL Subcommittee Report:

Dr. Movsas reported on concept replacement for Captopril.

V. Special Populations Subcommittee:

Dr. Roach reported that he has connected with Dr. Freeman who is heading Special Populations Network to see if collaboration with RTOG is feasible. Hispanic Recruitment grants team to revise aims and pursue development for June 1 or Oct 1, 2004.

VI. Economic Impact Subcommittee:

Dr. Konski reported on Clinical Trials with economic endpoints. The following RTOG studies. RTOG 9714 is closed. RTOG 0315 the Sandostatin study, RTOG 0232 a prostate study. Publications were done RTOG 8610 that was presented at ASTRO 03, a manuscript submitted to JCO “The RTOG Outcomes Model: Economic Endpoints and Measures which was Accepted Expert Opinion on Pharmacotherapy. RTOG 9003 has revision in progress and the lung cost effectiveness trial has revisions in progress as well.

VII. Epidemiology Subcommittee:

Dr. Bondy reported on the zip code study. Drs. Chamberlin and Bondy reported on preliminary analysis. Discussion of usefulness of income data. ACTION: more work needed to complete manuscript.

Dr. Bruner announced that Dr. Bondy is stepping down as co-chair after 10 years and we thank her for her years of service. The Epidemiology Committee has officially been disbanded and activities will be handled through Outcomes and/or TRP committee

VIII. PA Tobacco Settlement Funds:

Dr. Bruner reported that this is a 3 year, 3-phase project of outcomes by sociodemographic and quality of life variables. Year 1 H&N analyses, Year 2 Lung analyses and Year 3 Prostate analyses.

Dr. Konski reported Head and Neck results and that we have 5 abstracts submitted ACTION: 3 manuscripts in development.

Dr. Coyne is analyzing pilot data from a depression initiative prior to development of intervention trial

IX. Dissemination of Outcomes:

Dr. Bruner reported that a new Outcomes Committee endeavor is to have a formal plan for dissemination of all major studies.

RTOG 9714 - Dr. Hartsell reported on a formal plan for dissemination that includes the following

ACTIONS:

Dr. Hartsell presented results at the Plenary at ASTRO October 2003.

Dr. Hartsell presented at the Scientific Session at RTOG January 2004, Publication, which will be submitted to NEJM.

Dr. Hartsell to write an article for Supportive Care in Oncology.

Drs. Nora Janjan and Steve Lutz will be presenting a palliative radiotherapy refresher course at the National Hospice and Palliative Care Organization meeting in March 2004, in Las Vegas, and results of RTOG 9714 will be prominent part of lecture.

Dr. Lutz will also be submitting a Survey of Palliative Radiotherapy in Hospice data to the Annual Provincial Conference on Palliative and End-of-Life Care to be held in Toronto in April of 2004, and a review of RTOG 9714 results will be given as background.

Dr. Lutz has been named to the Examination Committee for the American Board of Hospice and Palliative Medicine and will suggest results of RTOG 9714 be included in palliative radiotherapy section on the board examination for Hospice and Palliative Medicine.

Dr. Bruner included results in 3rd edition of the Oncology Nursing Society Manual for Radiation Oncology Nursing Practice and Education in section on Palliative RT (in press).

Discussion of need to work with patient advocacy comm. to assist in dissemination of findings, Drs. Hartsell and Bruner will follow-up

X. RTOG Outcomes Resources:

Dr. Bruner reminded Outcomes Committee members of the resources available for development of outcomes and quality of life concepts and protocols available on RTOG website.

Outcomes Research Project Form
QOL Manual
QOL Video
Concept Development Process
Protocol Development Format and Process
Publication Policy

OUTCOMES COMMITTEE (June, 2003)

Benjamin Movsas, MD for Deb Bruner, PhD, Chair

I. Closed Studies:
RTOG 98-09 - Phase III PPS Status: accrued 176/180 (98%) of patients to initial QOL, closed March 2001 and analysis sent to PI 9/1/02, manuscript drafted in the queue
RTOG 94-08 - Phase III Endocrine Therapy Prior to RT for PC Status: accrued 662/751 (88%) of patients to the initial QOL component of the study, closed April 2001; primary analysis projected for spring, 2004
RTOG 97-14 - Bone Mets Status: closed in Summer 2002, accrued 877/877 (100%) of patients to the initial QOL component of the study, primary outcome will have a plenary at ASTRO ‘03, Dr. Bruner & Hartsell to analyze QOL data summer 03; Bruner and stats team will need to visit HUI group in Canada for training in HUI analysis in the Fall
RTOG 98-01 - Amifostine for NSCLC Status: closed in spring, 2002, accrued 234/239 (94%) of patients to the initial QOL component of the study; Dr. Movsas presented poster discussion abstract at ASCO. Dr. Werner-Wasik will present at ASTRO. Dr. Movsas will send out MS for review in September.
RTOG 99-01 - GM-CSF for Radiation Mucositis Status: closed December, 2002, accrued 74/82 (90%) of patients to the initial QOL component of the study; 35% of QOL forms missing, request sent to get all QOL forms in
RTOG 99-13 - Biafine for H&N Status: closed Spring 2002 accrued 357/486 (73%) of patients to the initial QOL component of the study; analysis will examine if we have complete enough QOL data for publication, request sent to get all QOL forms

II. Open Studies:
RTOG 99-03 - Erythropoietin for H&N Status: Activated June 2000 has accrued 129/372 pts (95 of as Jan mtg) with 88% initial QOL accrual; projected to close in 2009.
RTOG 0118 - Thalidamide Status: Activated Feb 2002, 72/332 accrued (25 as of Jan meeting). Dr. Scott has been emailing research associates to remind them of QOL measurements needed, has resulted in 93% QOL compliance at end of RT
RTOG 0126 - Phase III 3D prostate dose study Status: Activated in March 2002, 80/1520 accrued (25 as of Jan mtg) with 100% initial QOL accrual, projected completion 2017!, accrual issues will be discussed at the GU comm
RTOG 0213 - Phase II Celebrex for LANSCLC Status: Activated July 2002, poor accrual with 6/122 accrued (2 as of Jan mtg), accrual discussed at Lung comm
RTOG 0129 - Concurrent Standard vs Accelerated RT + Chemo in H&N Status: Activated July 2002, 110/480 accrued
RTOG 0214 - NSCLC PCI Status: Activated without QOL component September 2002 10/1508 accrued; QOL component sent to NCI for approval—approved summer ‘03
RTOG 0122 - Phase III Juven for Cancer Cachexia Status: Activated in December 2002, 20/468 accrued
RTOG 0215 - Sildanafil for ED (corollary for RTOG 9910) Status: Activated in January 2003 9/332 accrued—accrual issue discussed
RTOG 0212 - Phase II/III Doses Schedules For Delivering PCI in pts w SCLC Status: Activated in February 2003 0/264 accrued
RTOG 98-03 - Phase I dose escalation in GBM Status: 186 patients accrued with 98% initial QOL accrual.
RTOG 0123 - Phase II study of Captopril for lung sequellae (PI, Small, W, QOL PI, Lutz, S, Outcomes, Movsas B). Outcome Measures- EORTC (QLQ-C30 and QLQ-L13). Other endpoints include LENT scales and several pulmonary biochemical markers. Sample size 116. Status: opened.
RTOG 0232 - Phase III Brachy versus brachy plus external beam. (PI, Prestidge, B QOL PI, Sanda, M; Economic PI, Hartford, A; Utilities PI, Bruner DW). Outcome measures – EPIC and EQ5D, will collect cost at interested sites. Sample size 1520. Status: activated June ’03

III. Developing Concepts:
RTOG 0320 - Phase III, Three-Arm Trial in Pts With NSCLC and 1-3 Brain Metastases Comparing Whole Brain RT +Stereotactic Radiosurgery Alone vs with Temozolamide (Temodar) vs With Zd1839 (Iressa) (PI Sperduto, Outcomes PI Konski) Outcome measures – EQ5D + C. Sample size, 381. Status: Protocol in top 7 priority list to go to NCI, QAS secondary endpoint
RTOG 1026 - Phase III Sandostatin LAR depot for prevention of RT-induced diarrhea (PI, Zachariah, QOL PI, Gwede, Economics, Chin). Outcome measures – QOL-RTI, FACE (Changes in Bowel Function Scale), EPIC-Bowel, and the NCI-CTC diarrhea scale. Will include a C-E analysis (no measure of utility).Sample size, 226. Status: protocol concept approved by NCI--to go to DCP summer 2003
RTOG 0326 - Phase III trial of Ginseng for Radiation-Induced Fatigue. (PI, Fisher, J) The statistics are very complex (16 endpoints). Outcome Measures- Brief Fatigue Inventory, EORTC (QLQ-C30)Quality of Life Index (SQLI). Sample size, 648.
Status: To go back to NCI after revisions for approval
RTOG 0247 - Randomized Phase II Trial of Neoadjuvant Combined Modality Therapy For Locally Advanced Rectal Cancer. (PI Meropol; QOL PI, Kachnic, L) Outcome Measures- EORTC QLQ-C30; EORTC QLQ-CR 38 and the Functional Alterations due to changes in Elimination (FACE); Sexual Adjustment Questionnaire (SAQ). Sample size, ?. Status: protocol almost complete and is projected to go to the NCI by July
RTOG 0333 - Phase III intergroup trial comparing preop chemo vs preo chemoRT followed by surgery in pts with stage III NSCLC. (PI, Werner-Wasik; QOL PI Movsas).
Outcome Measures- EORTC QLQ-C30 hypothesis: preop QOL worse in RT arm but at 1 yr will be equivalent Status: in development

IV. Proposed Concepts:
Influence of Comorbidity on Survival in RTOG 94-10. (PI, Gore)
Status: Concept approved in 2002. Dr. Langer has a commitment for some pharmaceutical funding. Dr. Gore to pursue more funding.
Pancreas Phase III, (PI Willett, C) Status: Dr. Kachnic to f/u on QOL, RTOG 0247 (randomized phase II trial of neoadjuvant combined modality therapy for locally advanced rectal cancer. Will use the EORTC (QLQ-C30) and EORTC QLQ-CR38 as well as SAQ. (Dr. Kachnic).
Combined modality therapy of anal carcinoma in HIV infected patients (randomized phase II evaluating the role of Amifostine) Also to use the EORTC QLC-C30 and EORTC QLQ-CR38 (Dr. Kachnic).
Phase III trial of ethyol +/- adjuvant dutasteride to reduce late morbidity and recurrences in low risk prostate patients (Dr. Roach).
Bone targeted therapy using AMG-162 for men with recurrent high risk or progressive adenocarcinoma of the prostate: a Phase III trial (Dr. Roach).
GU Phase III EBRT + celebrex PI Pollack, QOL, Outcomes PI, Lee. Potential Outcome Measures EORTC QLQ30; EPIC; EQ5D Status: concept approved by Outcomes, GU CCOP Concepts requiring Outcome collaboration.

Dr. Larry Berk updated us a acupuncture for xerostomia (Streeter)
Gelclair for radiation mucositis (Kachnic)
cranberry extract for prostate radiation cystitis (possibleR21) (Berk)
lexapril for depression in Head & Neck (Wheeler)
gemcitabine and RT for bone mets (Berk)
saw palmetto for RT cystitis (Wyatt)
acupuncture/Tens for xerostomia (Wong)
zomeda plus radiopharmaceuticals for bone mets?
inhaled steroids for RT pneumonitis (McGarry)

Epidemiology Subcommittee Report-(Dr. Chamberlin)
Zip code study (Chamberlin/Bondy) (Stats to be done during Summer)
TRP Seed Grant Award:CYP3A4 Genotype and Clinical Characteristics of Prostate Cancer in African Americans (Tim Rebbeck)

Special Populations Subcommittee Report-Dr. Roach
SES in prostate cancer
Hispanic Recruitment grant

Economic Impact Subcommittee Report
0232 brachy study economic component (Hartford)
1026 Sandostatin (Octreotide study) C-E analysis (Lisa Chinn)
9714 (Konski/Bruner)- - possible grant to obtain Medicare data
8610 prostate C-E analysis of 86-01, prostate accepted for oral presentation at ASTRO
90-03 Quality-Adjusted Survival and Cost-Utility manuscripts

VIII. QOL Subcommittee Report-
Introduction of new QoL liaisons:
Geri Padilla, PhD CCOP QOL Liaison
Gwen Wyth, PhD Complimentary Medicine Liaison
Peggy Wilmoth, PhD Breast & Gyn Comm. Liaison,

IX. RTOG Outcomes Research Project Form-
Revised by Dr. Movsas and Outcomes Steering Committee

X. Publication Priority List – Top 15
1. 97-14 Primary and QOL papers should be submitted at the same time
2. RTOG ethnic and special population accrual using zip-code data (Outcomes Investigators, Bondy, M & Chamberlin, R).
3. QOL and Gender analysis by all disease sites that used FACT (Movsas B)
4. SAQ prostate (Bruner Abstract presented at ASTRO 1998)
5. 97-13 nurses skin toxicity scale (Fisher, J)
6. Long term QOL in prostate and H&N (Scott, C)
7. RTOG 98-05 - - QOL in prostate brachytherapy (Lee, WR)
Sociodemographic factors as predictors of prostate cancer outcomes (Outcomes Investigator, Roach, M)

Resubmissions or requiring revisions:

CYP3A4 & prostate cancer outcomes (Rebbeck, T) TRP study,
B. RTOG 98-01 Amifostine for non-small cell lung cancer
Movsas, Q-Twist Lung
Konski, Economic Lung
Konski, Economic H&N
F. Konski, Q-Twist H&N
G. QOL Assessment on RTOG 94-05, 1-Year follow-up Reveals no Difference in QOL between High & Conventional Dose RT (Kachnic, L)
RTOG 0018 neurocognitve abstract (Regine) – for re-submission
RTOG 9003 QOL – undergoing revisions

XI. Publications Submitted:
1. RTOG Outcomes Model (Bruner, et al)
Status: submitted to QOL Research, accepted pending minor revisions, resubmitted April ’03
2. CCOP - H&N trial RTOG 9003 Nutrition support and outcomes.
(Outcomes Investigator - Rabinovitch) - submitted

Pennsylvania Tobacco Outcomes Grant - -
The first disease site to be analyzed will be Head & Neck (Dr. Konski), followed by lung and prostate cancer.

NCI Funding Opportunities - -
Several program announcements were reviewed, related to aging and behavioral research. The idea of considering pilot qualitative (rather than quantitative) QOL research was reviewed.
Dr. Peggy Wilmoth has background in qualitative research and expressed an interest in this type of project.

OUTCOMES COMMITTEE (January, 2003)

Deborah W. Bruner, Ph.D.

I. Closed Studies:

RTOG 9809 - Phase III PPS for GI Toxicity (PI, Pilepich, M; QOL PI, Scott, C). Outcome measures- Medical Outcomes Survey (SF-12) and the Spitzer Quality of Life Index (SQLI), as well as Functional Assessment of Changes in Elimination, (FACE).

Status: accrued 176/180 (98%) of patients to initial QOL, closed March 2001 and analysis sent to PI 9/1/02, manuscript drafted.

RTOG 9408 - Phase III study of Endocrine Therapy as Cytoreductive/Static Agent Prior to RT for T1b-2b (PI, McGowan, QOL PI, Bruner, DW). Outcome measure- Sexual Adjustment Questionnaire (SAQ).

Status: accrued 662/751

(88%) of patients to the initial QOL component of the study, closed April 2001; analysis projected for Spring, 2003.

RTOG 9714 - Palliation of Bone Metastases (PI, Hartsell, W; Economic PI, Konski, A; QOL/Utilities PI, Bruner, DW; Pain PI, Cleeland, C). Outcome measures – FACT, Brief Pain Inventory; Health Utilities Index.

Status: closed in Summer 2002, accrued 877/877

(100%) of patients to the initial QOL component of the study, primary analysis due before ASTRO ‘03 submission, Dr. Bruner and stats team will need to visit HUI group in Canada for training in HUI analysis.

RTOG 9801 - Amifostine for non-small cell lung cancer (PI, Movsas, B; QOL PI, Sarna, L). Outcome measures -EORTC-30 & QLQ-LC-13.

Status: closed in Spring, 2002, accrued 234/239

(94%) of patients to the initial QOL component of the study; analysis due before ASTRO ‘03 submission.

RTOG 9901 - GM-CSF for Radiation Muscositis (PI, LeVeque, QOL PI, Johnson, D). Outcome Measures - UW-QOL.

Status: closed December, 2002, accrued 74/82

(90%) of patients to the initial QOL component of the study; Primary endpoint to be analyzed for ASTRO ’03, may not have time for QOL analysis for ASTRO ’03.

RTOG 9913 - Biafine© for Head and Neck Cancer (PI, Elliott, QOL PI, Scott, C).

Status: closed Spring 2002 accrued 357/486

(73%) of patients to the initial QOL component of the study; analysis will examine if we have complete enough QOL data for publication.

II. Open Studies:

RTOG 9803 - Phase I dose escalation in GBM (PI, Michalski, J; QOL PI, None). Outcome measures–MMSE, Spitzer Quality of Life Index (SQLI).

Status: has not reached MTD. Has accrued 95/97 patients with 98% initial QOL accrual.

RTOG 9903 - Erythropoietin for H&N Cancer (PI, Machtay, M; QOL PI, Johnson D & List, M). Outcome measures -Fatigue Symptom Inventory and QOL-RTI (H&N) and List Performance Status Scale and the Quality of Life Linear Analog Scale Assessment (LAS).

Status: Activated June 2000 has accrued 95/372 patients with 88% initial QOL accrual; projected to close in 2005.

RTOG 0118 - Thalidamide (PI Kinsely, J; QOL PI Scott, C.) Outcome Measures-

Status: Activated Feb 2002, 25/332 accrued. Dr. Scott has been emailing research associates to remind them of QOL measurements needed, has resulted in 93% QOL compliance at end of RT.

RTOG 0126 - Phase III 3D prostate dose study (PI, Michalski, J; QOL/Outcomes PI, Bruner, DW). Outcome measures - International Index of Erectile Function, FACE, Spitzer Quality of Life Index (SQLI), EPIC-bowel.

Status: Activated in March 2002, 25/1520 accrued with 100% initial QOL accrual.

RTOG 0213 - Phase II trial of Cox-2 Inhibitor, Celebrex for locally advanced non-small cell lung cancer (PI, Gore, E; QOL/Outcomes PI, Movsas, B) Outcome Measures- Lung Cancer Symptom Scale (LCSS), Activities of Daily Living Scale, IADL, GDS, MMSE, and SCFS.

Status: Activated July 2002, 2/122 accrued.

RTOG 0214 - NSCLC PCI (PI, Gore, B; QOL/Outcomes PI, Movsas, B) Outcome Measures- EORTC QLQ-C30 and BCM-20 Sample size, 1058.

Status: Activated September 2002, QOL to be amended before next meeting.

RTOG 0122 - Phase III trial of Nutritional Support with Juven for Cancer Cachexia (any site) (PI, Berk, L; QOL/Outcomes PI, Schwartz, A). The trial is limited participation trial at centers with bioimpedence measurement capability. Outcome Measures- Spitzer Quality of Life Index (SQLI) & Schwartz Fatigue Scale Sample size, 460.

Status: Activated in December 2002.

RTOG 0215 - Treatment of erectile dysfunction with Sildanafil (corollary for RTOG 99-10) (PI, Bruner, DW). Major issues- 1 ) only the one week window open at crossover to collect old drug, give new drug and do QOL assessments. 2) spouse or significant other assessment included in this study. Outcome measures –International Index of Erectile Function, Sexual Adjustment Questionnaire, Locke’s Marital Adjustment Questionnaire. Sample size, 332.

Status:

Activated in January 2003.

III. Developing Concepts:

RTOG 1061 - Phase II study of Captopril for lung sequellae of radiotherapy (PI, Small, W, QOL PI, Lutz, S). Outcome Measures- Lung Cancer Symptom Scale and the EORTC (QLQ-C30 and QLQ-L13). Other endpoints include LENT scales and several pulmonary biochemical markers. Sample size 116.

Status: final revisions back to NCI after Jan ’03 RTOG mtg.

RTOG 0232 - Phase III Brachy versus brachy plus external beam. (PI, Prestidge, B QOL PI, Sanda, M; Economic PI, Hartford, A; Utilities PI, Bruner DW). Outcome measures – EPIC and EQ5D, will collect cost at interested sites. Sample size 1520.

Status: revisions back to NCI (CIRB) 1-18-03.

RTOG 0320 - A Phase III, Three-Arm Trial In Patients With Non-Small Cell Lung Cancer And 1-3 Brain Metastases Comparing Whole Brain Radiation And Stereotactic Radiosurgery Alone Versus With Temozolamide (Temodar) Vs With Zd1839 (Iressa) (PI Sperduto, Outcomes PI Bruner) Outcome measures – EQ5D + C. Sample size, 381.

Status: Protocol being revised, QAS secondary endpoint to be added; will test proxy measures.

RTOG 1026 - Sandostatin LAR depot Phase III trial for prevention of radiation-induced diarrhea (PI, Zachariah, QOL PI, Gwede, Economics, Chin). Outcome measures – QOL-RTI, FACE (Changes in Bowel Function Scale), EPIC-Bowel, and the NCI-CTC diarrhea scale. Will include a C-E analysis (no measure of utility).Sample size, 226.

Status: protocol almost complete and is projected to go to the NCI by March ’03, Lisa Chinn needs to develop cost collection forms for inclusion.

RTOG 1066 - Phase III trial of Ginseng for Radiation-Induced Fatigue. (PI, Fisher, J) The statistics are very complex (16 endpoints) and Dr. Scott is working on this protocol. Outcome Measures- Brief Fatigue Inventory, Spitzer Quality of Life Index (SQLI) and POMS Sample size, 648.

Status: 3^rd on CCOP priority list, anticipated NCI submission date?

IV. Proposed Concepts:

Influence of Comorbidity on Survival in RTOG 94-10. (PI, Gore).

Status:

Pancreas Phase III, concepts in development Dr. Kachnic to f/u on QOL, Dr. Bondy (in conjunction with Dr. Gloria Peterson from Mayo) would like companion study looking at families for genetic linkage.

Status: research strategy & outcomes comm. encouraged concept submissions.

Rectal Phase II randomized PI Meropol QoL PI Kachnic Potential Outcome Measures EORTC QLQ30; SAQ, FACE.

Status: although Outcomes comm. usually does not approve QOL endpoints on Phase II studies, this 3 arm randomized concept presents a unique opportunity and concept including QoL was approved by Outcomes.

GU Phase III EBRT + celebrex PI Pollack, QOL, Outcomes PI, Lee. Potential Outcome Measures EORTC QLQ30; EPIC; EQ5D.

Status: concept approved by Outcomes.

CCOP Approved Concepts requiring Outcome endpoints – presented by Dr. Berk.

V. Epidemiology Subcommittee Report: Melissa Bondy, Ph.D.

Drs. Bondy and Chamberlin analysis of accrual into RTOG trials by special populations (using zip-code data) is 1^st on Outcomes priority list.
Dr. Rebbeck’s TRP Seed Grant Award:CYP3A4 Genotype and Clinical Characteristics of Prostate Cancer in African Americans, will complete analysis when the primary treatment paper for RTOG 90-02 has been accepted for publication, it was submitted in Fall 2002. The Seed Grant was awarded in 1998 and the genotyping for the CYP3A4*1B variant was completed in Spring 2001.
Dr. Bondy proposed a concept of family ascertainment for a pancreas and brain linkage study from prospective RTOG trials. Concept approved by research strategy and Outcomes.

VI. Special Populations Subcommittee Report: Mack Roach, III, M.D.

Dr. Roach, is awaiting statistical analysis of the SES data in prostate cancer patients, approved for secondary analysis by Publications Committee in 1999.
Dr. Aidnag Diaz , Chair of the Special Populations Subcommittee task force on Hispanic Recruitment is continuing to develop a grant proposal to improve Hispanic recruitment into RTOG clinical trials for tentative NIH submission June 1 or Oct 1, 2003.

VII. Economic Impact Subcommittee Report: Andre Konski, M.D.

RTOG 0232 - A brachytherapy study which has an economic component and Dr. Hartford is preparing a companion protocol and grant submission potentially for June 1, 2003 to NIH to link Medicare data to the cost data collected in the primary study.
Status: preparing for a possible June 1 NIH submission.
RTOG 1026 - Sandostatin has a C-E analysis endpoint with Lisa Chinn as Economics PI.
Status: protocol almost complete and is projected to go to the NCI by March, cost collection forms need to be included.
RTOG 9714 - Economic analysis linking Medicare data to clinical outcomes.
Status: Dr. Konski, PI preparing for a Feb 1 NIH Submission.
RTOG 8601 - Prostate C-E analysis of RTOG 86-01, prostate.
Status: Drs. Konski, Beck and Sherman will be conducting a Monte-Carlo simulation analysis.

VIII. QOL Subcommittee Report - Benjamin Movsas, M.D.

Strategic Planning Meeting was held in Philadelphia on September 18, 2002. The executive summary is:
Consensus is a need for some consistent measures of QOL and Outcomes across sites.
Recommendation: each QOL appropriate Phase III study to include the general and site specific EORTC QOL instruments.
QOL appropriate” studies should be divided into those studying “poor prognosis” patients (e.g., brain mets) vs. “better prognosis” patients (e.g.. Locally advanced NSCLC or beyond, such as prostate).
The plan to incorporate the EORTC instruments applies to the latter group.
For the “poor prognosis” group, a more abbreviated QOL instrument should be utilized.
Recommendation: the addition of the 5-item EQ 5D for any study, in which quality-adjusted survival is an appropriate endpoint.
Additional measures tailored to specific hypotheses will be added at the discretion of the investigators.
Dr. Movsas, is in the process of recruiting several senior researchers as QOL.
Liaisons. These scientists will assist in moving forward an agenda of interventional QOL research and grant funding.
Drs. Movsas, Bruner, Scott & Darlene Johnson presented on QOL at RA scientific session 1/24/03.

IX. Depression Initiative – James Coyne, M.D.

NCI has set depression as a research priority.
Dr. Coyne will initially assess depression as part of the PA Tobacco settlement grant.
Interventional concepts related to depression will be submitted after the initial analysis.

X. Accrual/Publications Report – Chuck Scott, Ph.D.

Overall Total Baseline QOL Accrual 6870/7650 patients or 90% baseline compliance.

OUTCOMES COMMITTEE (June, 2002)

Deborah Watkins-Bruner, R.N., Ph.D., Chair

New Activities And Members

George Perkins, M.D. is our new investigator member. A report is currently available from the NIA-NCI Strategy-Planning Meeting on Cancer Treatment Trials for Older Patients which was held May 13, 2002 in Maryland. Minutes are available in a 28 page document and those who are interested in obtaining a copy can email Deb Bruner at D_Watkins-Bruner@fccc.edu.

The purpose of the meeting was to agree on the best framework for increasing accrual of older patients onto Cooperative Group Trials and to arrive at a clinical trials framework through which the Cooperative Groups and NCI can define optimal treatment for older patients with cancer. Recommendations are to determine ways to educate IRBs and physicians about enrolling older patients, evaluating instruments that will aid in categorizing elderly patients into the categories (fit, vulnerable, frail). NCI and NIA must determine ways to stimulate and fund more research in older cancer patients and intergroups should be established to focus on cancer in the elderly.

The Cancer and Leukemia Group B (CALGB) Oncology Nursing Committee sponsored the first "Cooperative Group Cancer Nursing Research Summit", held in Washington, DC. This initiative involved nursing leaders representing the National Cancer Institute (NCI), the National Institute of Nursing Research (NINR), the Komen Foundation, the American Cancer Society (ACS), and the Oncology Nursing Society (ONS). In addition, nine cooperative research groups were represented (CALGB, SWOG, COG, GOG, ECOG, NSABP, NCCTG, ACOSOG) with Deborah Watkins Bruner, R.N., Ph.D., representing the RTOG. The goal of the meeting was to exchange information and begin collaborations that would facilitate the conduct of multi-site nursing research within the cooperative group setting. RTOG may be collaborating in several future endeavors. Dr. Ann O’Mara announced the NIH State of the Science Conference on Symptom Management in Cancer: Pain, Depression and Fatigue which is being held on July 15-17, 2002 in Bethesda, Maryland.

Outcomes & QOL Committees Liaison Reports of Open Studies and New Concepts

1. Brain Tumor

Dr. Choucair stated that there are currently no open brain studies with formal QOL or other outcomes hypothesis. There will be a discussion at the Brain Tumor Committee meeting regarding a QOL/neurocognitive template to use on future studies. RTOG 98-03 a Phase I dose escalation in GBM that measured MMSE, Spitzer (SQLI) was recently closed. It was 97% compliant with outcome measures and accrued 114/117 patients. There will be discussion in the Brain Tumor Committee meeting regarding a QOL/neurocognitive template to use on future studies.

Dr. Jon Glass presented RTOG 02-27 a Phase II study concept using pre-RT chemotherapy with Methotrexate, Rituximab and Temozolomide for primary CNS lymphoma using Spitzer and MMSE outcome measures. Dr. Sperduto presented a stereotactic study that the outcome measures and principal investigator will be announced at a later date.

Dr. Choucair was to present a concept to the Brain Tumor and Neurosurgery Committees for a comprehensive set of quality of life and neurocognitive measures to be used as a template on this and future studies.

2. Head & Neck Cancer

Dr. Scott reported on RTOG 99-13 a study using Biafine ® for Head and Neck Cancer that measured Spitzer (SQLI) which was recently closed. It was 83% compliant with outcome measures (head and neck radiotherapy questionnaire) and accrued 160/192 patients.

Darlene Johnson reported on RTOG 99-01 a GM-CSF study for radiation muscositis which was recently opened. It is expected to be 81% compliant with QOL measures and accrual should be 29/26. This study is anticipated to close by the end of the year.

Dr. Mitchell Machtay who is the Principal Investigator for RTOG 99-03 a study using Erythropoietin for H&N Cancer using outcome measures of fatigue with symptom inventory which includes a list performance status scale along with a quality of life linear analog scale assessment. The accrual on this study is expected to be 29/31 with (94%) compliance of QOL/outcome measures. This study is accruing slowly and Dr. Machtay announced in the Head and Neck Cancer Committee meeting that we are now offering double case credit and .5 Cancer Control credit due to additional pharmaceutical support.

RTOG 02-26 is a Phase III approved concept chemoprevention trial to prevent second primary tumors with Celebrex^TM in patients with head and neck cancer and outcome measures will be announced at a later date. Dr. Murphy reported that a grant has recently been submitted to the NCI, RTOG H-0219 on correlative nutrition status and a quality of life study of patients on RTOG 1069 to compare CCR vs. CCR +HRT for head and neck cancers.

3. Lung Cancer

Dr. Benjamin Movsas reported on RTOG 98-01 an Amisfostine study for NSCLC which was closed recently. Outcome measures included EORTC-30 and QLQ-LC-13. The accrual on this study is expected to be 169/181 with (93%) compliance with QOL measures.

Dr. Bruner reported for Dr. Lutz on developing study 1061 a Phase II study of Captopril for lung sequellae of radiotherapy with outcome measures using EORTC (QLQ-C30 and QLQ-L13); LENT scales & several pulmonary biochemical markers. It has been tentatively approved by the NCI, and is being revised.

Dr. Movsas reported on developing study 02-13 Phase II Cox-2 Inhibitor, Celebrex for LA-NSCLC using outcome measures of Lung Cancer Symptom Scale (LCSS), Activities of Daily Living Scale, GDS, MMSE, and SCFS. This study will be opening shortly.

The intergroup study 02-14, with PCI for NSCLC using neurocognitive and QOL is to be collected in North American participants only. The outcome measures will be the neurotoxicity testing (MMSE, HVLT, ADLS), QOL EORTC (QLQ-C30 and QLQ-L13).

A proposed concept that should be considered would look at the influence of comorbidity on survival in RTOG 94-10 which would need separate funding and R01.

4. Gastrointestinal Cancer

Dr. Kachnic reported that there are multiple Phase II GI trials open without QOL or other Outcomes endpoints and there are currently no Phase III GI studies planned. GI outcomes studies currently involve two secondary analyses of RTOG 94-05 and 94-01. There are currently no open studies as well as approved or proposed concepts.

5. Genitourinary Cancer

Dr. Bruner reported on the recently opened study RTOG P-0126 which is a Phase III 3D prostate dose study using outcome measures with an international index of erectile function, FACE, Spitzer (SQLI) and EPIC-bowel. The first two patients just accrued.

The recently approved concept RTOG P-0215 a Phase III Treatment of erectile dysfunction with Sildanafil which is a corollary study for RTOG 99-10. The outcome measures are IIEF, SAQ and Lockes Marital Adjustment Questionnaire. The NCI gave it a favorable review which needs to be submitted by July 12, 2002.

Dr. Movsas gave a report on the developing study RTOG 1042, a Phase III Carafate study to prevent late bowel toxicity during prostate cancer treatment. This study will not go forward since the pharmaceutical company is no longer interested in supporting it.

Dr. Chin reported on the developing study 1026 a Phase III Sandostatin for prevention of radiation-induced diarrhea using outcome measures of QOL-RTI, FACE (Bowel Function Scale), EPIC-Bowel, and the NCI-CTC diarrhea scale. Dr. Andre Konski reported on the costs involved. Another developing study 1084 using Brachytherapy versus brachytherapy plus external beam using outcome measures, EPIC and EuroQol 5D was presented.

6. Cancer Control

Dr. Konski gave a report of the recently opened RTOG 97-14 a Palliation of Bone Metastases using outcome measures of FACT, BPI and measure of utility-HUI Accrual is expected to be 772/772 (100%) with outcome measures.

Dr. Berk reported on the concept RTOG 1050 a Phase I/II Combination of bis-phosphonates and Samarium 153 for a symptomatic bone metastases which has been approved.

The developing study RTOG 1005 a Phase III study with Nutritional Support using Juven for Cancer Cachexia with outcome measures using the Spitzer (SQLI) & Schwartz Fatigue Scale was discussed. The statistics have been completed on the proposed concept using Ukrain for palliative treatment of pancreatic cancer with outcome measures that were the same ones used on the Gemzar study including KPS, and weight loss.

7. Epidemiology Report

Dr. Bruner reported for Dr. Bondy about the secondary analysis of outcomes by sociodemographic variables obtained from zip-code data is the number one priority of the Epidemiology Committee. Senior Statistician Kathy Winter will have the data read by the end of August 2002. Dr. Tim Rebbeck’s analysis of CYP3A4 is high on the priority list, awaiting the primary paper (RTOG 92-02) to be submitted for publication. Dr. Pajak will be submitting this manuscript soon.

8. Special Populations Report

Dr. Diaz reported on the efforts of Hispanic Task Force. Dr. Diaz is working on a grant with Drs. Bruner and Roach as co-investigators to pilot interventions to improve Hispanic recruitment on two RTOG trials, a brain mets study and the Phase III head and neck study. There will be limited participation in this study which will include the University of Miami and University of Texas, San Antonio.

9. Economic Impact Report

Dr. Konski reported on several secondary analyses which are planned including a reanalysis with modeling of costs for RTOG 86-10 and an expanded analysis of a study of sociodemographic factors as predictors of head and neck cancer outcomes.

10. QOL Report

Dr. Movsas reported on the NCI HRQOL page which is being added to the CTEP website (http://ctep.cancer.gov/) due to be functioning by late summer 2002. Presentations are planned for the Group Chairs Meeting on January 31, 2003. Each Cooperative Group will nominate several trials in which HRQOL played a major role in study outcomes. The key elements for successful HRQOL research in multi-institutional studies, including HRQOL expertise, data management, handling of delinquent data, and compliance will be outlined. Avenues for financial support of HRQOL through CTEP and DCP will also be discussed. An Education Session at the ASCO 2003 meeting has been proposed tentatively entitled “State of the Art in HRQOL Research: 2003,” and would include the Cancer Outcomes Measurement Working Group (COMWG), the Mayo Clinical Significance Consensus Meeting Group, and a summary of Cooperative Group efforts in HRQOL.

11. Accrual/Publications Report

Dr. Scott reported as of 6/02 that RTOG has accrued 6394/7082 subjects to protocols with QOL and outcomes endpoints accounting for 90% compliance at the initial assessment. Follow-up accrual has been variable and both Drs. Movsas and Scott have proposed a concept for a grant to assess methods or real time tracking to improve QOL data collection.

12. The Mayo Meeting

Dr. Scott gave an overview of the Mayo Meeting titled “Assessing Clinical Significance for Quality of Life Measures in Oncology Research: State-of-the-Science” which was held from April 5-6, 2002 in Rochester, MN. The Outcomes Committee discussed ways to incorporate measures of clinical significance into current and future trials with QOL endpoints. Proceedings have been published in a series that include the following seven articles:

1. Sloan JA, Cella D, Frost M, Guyatt GH, Sprangers M, Symonds T; Clinical Significance Consensus Meeting Group. Assessing clinical significance in measuring oncology patient quality of life: introduction to the symposium, content overview, and definition of terms. Mayo Clin Proc 2002 Apr;77(4):367-70.
2. Guyatt GH, Osoba D, Wu AW, Wyrwich KW, Norman GR; Clinical Significance Consensus Meeting Group. Methods to explain the clinical significance of health status measures. Mayo Clin Proc 2002 Apr;77(4):371-83.
3. Cella D, Bullinger M, Scott C, Barofsky I; Clinical Significance Consensus Meeting Group.Group vs individual approaches to understanding the clinical significance of differences or changes in quality of life. Mayo Clin Proc 2002 Apr;77(4):384-92
4. Sloan JA, Aaronson N, Cappelleri JC, Fairclough DL, Varricchio C; Clinical Significance Consensus Meeting Group. Assessing the clinical significance of single items relative to summated scores. Mayo Clin Proc 2002 May;77(5):479-87.
5. Frost MH, Bonomi AE, Ferrans CE, Wong GY, Hays RD; Clinical Significance Consensus Meeting Group. Patient, clinician, and population perspectives on determining the clinical significance of quality-of-life scores. Mayo Clin Proc 2002 May;77(5):488-94.
6. Sprangers MA, Moinpour CM, Moynihan TJ, Patrick DL, Revicki DA; Clinical Significance Consensus Meeting Group. Assessing meaningful change in quality of life over time: a users' guide for clinicians. Mayo Clin Proc 2002 Jun;77(6):561
7. Symonds T, Berzon R, Marquis P, Rummans TA; Clinical Significance Consensus Meeting Group. The clinical significance of quality-of-life results: practical considerations for specific audiences. Mayo Clin Proc 2002 Jun;77(6):572-83.

OUTCOMES COMMITTEE (January, 2002)

Deborah Watkins Bruner, Ph.D., Chair

I. Closed Studies:

RTOG 98-09 - Phase III PPS for GI Toxicity (PI, Pilepich, M; QOL PI, Scott, C). Study was closed due to withdrawal of the drug. It is currently being analyzed and the data should be available by the end of October. Outcome measures- the Medical Outcomes Survey (SF-12) and the Spitzer Quality of Life Index (SQLI), as well as Functional Assessment of Changes in Elimination, (FACE).

Status: accrued 176/180 (98%) of patients to initial QOL, closed March 2001 and analysis sent to PI

RTOG 94-08 - Phase III study of Endocrine Therapy as Cytoreductive/static Agent Prior to RT for T1b-2b (PI, McGowan, QOL PI, Bruner, DW). Outcome measure- Sexual Adjustment Questionnaire (SAQ).

Status: accrued 662/751 (88%) of patients to the initial QOL component of the study, closed April 2001 and analysis projected after 2 year follow-up.

II. Open Studies:

RTOG 97-14 - Palliation of Bone Metastases (PI, Hartsell, W; Economic PI, Konski, A; QOL/Utilities PI, Bruner, DW; Pain PI, Cleeland, C). This study gives .7 ca control credits to CCOPs and 1.0 RTOG case credit to all other institutions. Outcome measures – FACT, Brief Pain Inventory; Measure of utility- Health Utilities Index.

Status: has accrued 776/938 patients with 100% QOL and utilities accrual and will close in Summer 2002

RTOG 98-01 - Amifostine for non-small cell lung cancer (PI, Movsas, B; QOL PI, Sarna, L). Survival was shifted from being a primary endpoint to a secondary endpoint, lowering the number of patients needed to complete the trial. This is open to the CCOPs. Outcome measures -EORTC-30 and the QLQ-LC-13.

Status: has accrued 208/244 patients with 96% initial QOL accrual and will close in Spring, 2002.

RTOG 98-03 - Phase I dose escalation in GBM (PI, Michalski, J; QOL PI, None).

Outcome measures – MMSE, Spitzer Quality of Life Index (SQLI).
Status: has not reached MTD. Have accrued 95/97 patients with 98% initial QOL accrual.

RTOG 99-01 - GM-CSF for Radiation Muscositis (PI, LeVeque, QOL PI, Johnson, D). Outcome Measures - UW-QOL. This is a CCOP study also open to non-CCOP centers.

Status: has accrued 42/126 patients and will close around February, 2003.

RTOG 99-03 - Erythropoietin for H&N Cancer (PI, Machtay, M; QOL PI, Johnson D & List, M). Opened to accrual June 30, 2000, has picked up slowly in accrual rate. It now has 32 of 372 needed patients. Platinum is now allowed to be given concurrently with radiation therapy. It is also open to non-CCOP centers. Outcome measures -Fatigue Symptom Inventory and QOL-RTI (H&N) and List Performance Status Scale and the Quality of Life Linear Analog Scale Assessment (LAS).

Status: has accrued 34/372 patients with 88% initial QOL accrual and is projected to close in 2015.

RTOG 99-13 - (Biafine for Head and Neck Cancer) (PI, Elliott, QOL PI, Scott, C). This study is accruing rapidly. This is a CCOP study also open to non-CCOP centers. Outcome Measures- Head and Neck Radiotherapy Questionnaire (QOL-RTI -H&N) and the Spitzer Quality of Life Index (SQLI).

Status: has accrued 301/498 patients with 78% QOL accrual and will close in Spring, 2002

III. Approved Concepts:

RTOG 01-26 - Phase III 3D prostate dose study (PI, Michalski, J; QOL/Outcomes PI, Bruner, DW). An amendment to allow for IMRT is being considered. If this is approved, a cost-utility analysis may also be added. Outcome measures - International Index of Erectile Function, FACE, Spitzer Quality of Life Index (SQLI), EPIC-bowel. Sample size, 1520.

Status: resubmitted to NCI

RTOG 02-15 - Treatment of erectile dysfunction with Sildanafil (corollary for RTOG 9910) (PI, Bruner, DW). Study has been funded through National Institutes of Nursing Research (NINR). First on priority list for NCI submission after RTOG meeting. Patient’s partners to be recruited. Major issue to remember is the one week window open at crossover to collect old drug, give new drug and do QOL assessments. Outcome measures –International Index of Erectile Function, Sexual Adjustment Questionnaire, Lockes Marital Adjustment Questionnaire. Sample size, 332.

Status: to be submitted to NCI in Spring

RTOG 10-02 - A Phase III Trial Comparing Stereotactic Radiosurgery Alone Vs Whole Brain RT And Stereotactic Radiosurgery For 1-3 Unresected Brain Mets (PI, Sperduto, P, Outcomes PI, Bruner, DW) Quality Adjusted Survival is primary endpoint. Outcome measures - EuroQol-Brain Module, EQ-5D, Spitzer Quality of Life Index (SQLI).

Status: to be submitted to DCP in February

RTOG 10-61 - Phase II study of Captopril for lung sequellae of radiotherapy (PI, Small, W, QOL PI, Lutz, S). Outcome Measures- Lung Cancer Symptom Scale and the EORTC (QLQ-C30 and QLQ-L13). Other endpoints include LENT scales and several pulmonary biochemical markers. Sample size, 116.

Status: resubmitted to NCI

RTOG 10-17 - Phase III study of Interleukin-II for prevention of thrombocytopenia with increasing doses of Strontium 89 for patients with symptomatic bone metastases. (PI, , QOL/Outcomes PI, TBN). It has been reviewed at the NCI and is being converted to a Phase I dose-seeking trial, and then to be expanded as a Phase II trial. Outcome may not be measured in the Phase I trial.

Status: awaiting resubmission to DCP

RTOG 10-42 - Phase III trial of Carafate to prevent late bowel toxicity during prostate cancer treatment (PI, Movsas, B; QOL PI, Sanda, M). Outcome Measures – EPIC, Spitzer Quality of Life Index (SQLI). Sample size, 400.

Status: protocol written, needs to be submitted to NCI

RTOG 10-50 - Phase I/II trial of the combination of bisphosphonates and Samarium 153 for a symptomatic bone metastases. (PI, Seider, QOL/Outcomes PI, TBN). Outcome Measures – TBN

Status: concept approved 2-11-01, protocol has not been written

RTOG 10-26 - Sandostatin LAR depot Phase III trial for prevention of radiation-induced diarrhea (PI, Zachariah, QOL/Outcomes PI, Gwede, C; Economic PI, Chin,L). The protocol is being prepared for submission to the NCI. Novartis Oncology will partially fund the study. The Outcomes committee requested the addition of a cost-utility objective to this study. Outcome measures - QOL-RTI, FACE (Changes in Bowel Function Scale), EPIC-Bowel, and the NCI-CTC diarrhea scale. Sample size, 226.

Status: protocol almost complete and is projected to go to the NCI by March

RTOG 10-05 - Phase III trial of Nutritional Support with Juven for Cancer Cachexia (PI, Berk, L; QOL/Outcomes PI, Schwartz, A). the trial has been to the NCI twice and is in process of revision #3. The trial will be modified to be a limited participation trial at centers with bioimpedence measurement capability. The manufacturer has agreed to supply impedence units and substantial funding. Outcome Measures- Spitzer Quality of Life Index (SQLI) & Schwartz Fatigue Scale Sample size, 460.

Status: study resubmitted to DCP

RTOG 10-66 - Phase III trial of Ginseng for Radiation-Induced Fatigue. (PI, Fisher, J) The statistics are very complex (16 endpoints) and