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0421 Broadcast

DATE: February 19, 2009

SUBJECT: RTOG Study Terminations

RTOG Study Terminations

The studies listed below are completed and will be terminated as of February 19, 2009. As of that date all study activity and data collection will cease, and institutions should notify their local IRBs/REBs of the terminations.

Any data received at RTOG Headquarters after February 19, 2009 will be returned to the submitting institution.

Brain:
RTOG 0013: A Phase II Trial of Conventional Radiation Therapy Followed by Intratumoral Bleomycin Delivered Using a Refillable, Sustained Release Device (IND# 46,592) for the Treatment of Supratentorial Glioblastoma
RTOG 0021: A Phase II Trial of Conventional Radiation Therapy Plus High DoseTamoxifen for the Treatment of Supratentorial Glioblastoma Multiforme (GBM)
RTOG 0023: A Phase II Trial of Accelerated Radiotherapy Using Weekly Stereotactic Conformal Boosts for Supratentorial Glioblastoma Multiforme
RTOG 0118: A Phase III Study of Conventional Radiation Therapy Plus Thalidomide (NSC# 66847) Versus Conventional Radiation Therapy for Multiple Brain Metastases
RTOG 0119: A Randomized Phase II Study of A.M. And P.M. Melatonin for Brain Metastasis on RPA Class II Patients

Head & Neck:
RTOG 0421: A Phase III Trial for Locally Recurrent, Previously Irradiated Head and Neck Cancer: Concurrent Re-Irradiation and Chemotherapy Versus Chemotherapy Alone

Lung:
RTOG 0412: Phase III Randomized Trial of Preoperative Chemotherapy Versus Preoperative Concurrent Chemotherapy and Thoracic Radiotherapy Followed by Surgical Resection and Consolidation Chemotherapy in Favorable Prognosis Patients with Stage IIIA (N2) Non-Small Cell Lung Cancer

Symptom Management:
RTOG 97-14: Randomized Trial of Palliative Radiation Therapy for Osseous Metastases: A Study of Palliation of Symptoms and Quality of Life
RTOG 0122: Double-Blind Study of Nutritional Intervention for the Treatment of Cancer Cachexia Using Juven® Nutritional Supplement
RTOG 0435: A Randomized, Phase III, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Palifermin (NSC# 740548; IND #100,192) for the Reduction of Oral Mucositis in Patients with Locally Advanced Head and Neck Cancer Receiving Radiation Therapy with Concurrent Chemotherapy (Followed by Surgery for Selected Patients)

Please notify your affiliates that are not on e-mail.

If you would like to be added or removed from the RTOG broadcast list or wish to update your e-mail address, contact Michelle Buado at mbuado@phila.acr.org.

Sites should not contact Michelle Buado for any other reason or reply directly to this broadcast. Institutions can share a comment or ask a question by accessing the appropriate department at RTOG Headquarters on the RTOG web site at www.rtog.org; select the member information tab, and click Headquarters Information and Telephone Listings. Sites also can call 1-800-227-5463, ext. 4189, which provides prompts to reach each department.
DATE: July 7, 2008

SUBJECT: Form Revision Notice - F1/FS Revisions on Multiple Studies

Form Revision

Multiple RTOG Studies

F1/FS revisionr

The following forms have been revised. Download the new version from the RTOG web site at http://www.rtog.org/members/forms/list.html The edition code for case report forms is found in the lower right corner of the form.

Form TypeNew Version Code/Date
522F1    522F1c     7-3-08
822F1    822F1a     6-26-08
630F1a    630F1b     6-26-08
623F1    623F1a     6-26-08
618F1    618F1a     6-26-08
617F1a    617F1b     6-26-08
615F1b    615F1c     6-26-08
529F1    529F1a     6-26-08
438F1c    438F1d     6-26-08
435FSb    435FSc     6-26-08
435F1b    435F1c     6-26-08
421F1    421F1a     7-2-08
418F1    418F1a     6-26-08
417F1    417F1a     6-26-08
411F1a    411F1b     6-26-08
330F1a    330F1b     6-26-08
247F1b    247F1c     6-26-08
234F1b    234F1c     7-1-08
 
Changes Made: These all involved changes to the Progression and/or New Primary Tables.

Discard obsolete versions and commence use of the revised editions immediately. Obsolete versions received on or after July 15, 2008 will be returned to the site for transcription.

Please notify your joint center institutions and affiliates who are not on e-mail.

Wendy Bergantz, RN

RTOG Data Management

Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html
DATE: March 27, 2007

SUBJECT: Amendment of CTSU logistics: RTOG 0214, 0415, 0421, 0521, 0522

At the request of the Cancer Trials Support Unit (CTSU), RTOG has amended the CTSU logistics in the following studies:

RTOG 0214, “A Phase III Comparison Of Prophylactic Cranial Irradiation Versus Observation In Patients With Locally Advanced Non-Small Cell Lung Cancer”

RTOG 0415, “A Phase III Randomized Study of Hypofractionated 3D-CRT/IMRT Versus Conventionally Fractionated 3D-CRT/IMRT in Patients With Favorable-Risk Prostate Cancer”

RTOG 0421, “A Phase III Trial For Locally Recurrent, Previously Irradiated Head And Neck Cancer: Concurrent Re-Irradiation And Chemotherapy Versus Chemotherapy Alone" (Closed)

RTOG 0521, “A Phase III Protocol of Androgen Suppression (AS) and 3DCRT/IMRT vs AS and 3DCRT/IMRT Followed by Chemotherapy with Docetaxel and Prednisone for Localized, High-Risk Prostate Cancer”

RTOG 0522, “A Phase III Trial of Concurrent Accelerated Radiation and Cisplatin Versus Concurrent Accelerated Radiation, Cisplatin, and Cetuximab (C225) [Followed by Surgery for Selected Patients] for Stage III and IV Head and Neck Carcinomas”

Please see the complete Summary of Changes for each study at

http://www.rtog.org/members/protocols/0214/summary_changes.html
http://www.rtog.org/members/protocols/0415/summary_changes.html
http://www.rtog.org/members/protocols/0421/summary_changes.html
http://www.rtog.org/members/protocols/0521/summary_changes.html
http://www.rtog.org/members/protocols/0522/summary_changes.html

Sites can download a copy of each protocol for IRB review at
http://www.rtog.org/members/protocols/0214/0214.pdf
http://www.rtog.org/members/protocols/0415/0415.pdf
http://www.rtog.org/members/protocols/0421/0421.pdf
http://www.rtog.org/members/protocols/0521/0521.pdf
http://www.rtog.org/members/protocols/0522/0522.pdf

NCI policy requires that the "Version Date" on the protocol title page reflect the date the amendment was submitted by RTOG to NCI; for clarity, the broadcast date is provided in parentheses.

Per CTMB Guidelines, amendments must be submitted and approved by local IRBs within 90 days. Expedited review is allowed; however, site IRB requirements take precedence.

Please notify your affiliates that are not on e-mail.

Web registration is available 24/7. Information and instructions are at https://silver2.phila.acr.org/Clinical_RTOG/pgIndex.html

DATE: January 05, 2007

SUBJECT: RTOG 0421, Closure

Closure

RTOG 0421, “A Phase III Trial for Locally Recurrent, Previously Irradiated Head and Neck Cancer: Concurrent Re-Irradiation and Chemotherapy Versus Chemotherapy Alone", will close to patient accrual today, Friday, January 5th at the close of the business day (5 p.m., EST), due to not meeting accrual goals. (Notice of this closure was previously broadcast on 12/22/06)

Please notify your affiliates that are not on e-mail.

To share a comment or ask a question, access the Headquarters Information and Telephone Listing on the RTOG web site, www.rtog.org, under "Member Info", or call 1-800-227-5463, ext. 4189, which provides a menu to reach the Headquarters departments.If you would like to be added/removed from the RTOG broadcast list or wish to update your e-mail address, contact Michelle Buado at mbuado@phila.acr.org.

Web registration is available 24/7. Information and instructions are at https://silver2.phila.acr.org/Clinical_RTOG/pgIndex.html

DATE: December 22, 2006

SUBJECT: RTOG 0421, Closure

Closure

RTOG 0421, "A Phase III Trial for Locally Recurrent, Previously Irradiated Head and Neck Cancer: Concurrent Re-Irradiation and Chemotherapy Versus Chemotherapy Alone", will close to patient accrual on Friday, January 5th at the close of the business day, due to not meeting accrual goals. (Patients in the process of pre-registration evaluations for the study can be enrolled until 1/5/07.)

Please notify your affiliates that are not on e-mail.

To share a comment or ask a question, access the Headquarters Information and Telephone Listing on the RTOG website, www.rtog.org, under "Member Info", or call 1-800-227-5463, ext. 4189, which provides a menu to reach the Headquarters departments. If you would like to be added/removed from the RTOG broadcast list or wish to update your e-mail address, contact Michelle Buado, mbuado@phila.acr.org.

Web registration is available 24/7. Information and instructions are at https://silver2.phila.acr.org/Clinical_RTOG/pgIndex.html

DATE: October 11, 2006

SUBJECT: Form Revision Notice - RTOG 0421

FORMS REVISION
RTOG 0421
Phase III Head & Neck

The following form for this study has been revised. Download the new version from the RTOG web site at
http://www.rtog.org/pdf_forms.html?members/forms=0421/0421i1.pdf
The edition code for case report forms is found in the lower right corner of the form.


Form Type New Version Code/Date
I1 Initial Evaluation Form I1a   10-10-06
 
Changes Made: Question 7: Hospitalized for COPD or other respiratory illness in last 6 months.This is no longer a requirement . It will be shaded to indicate it does not need to be answered.

Discard obsolete versions and commence use of the revised edition immediately. Obsolete forms received after October 20, 2006 will be returned to the site for transcription.

Please notify your joint center institutions and affiliates who are not on e-mail.

Linda Messett
RTOG Data Management

Web registration is available 24/7. Information and instructions are at https://silver2.phila.acr.org/Clinical_RTOG/pgIndex.html

DATE: October 10, 2006

SUBJECT: RTOG 0421, Amended

Amended

RTOG 0421, "A Phase III Trial for Locally Recurrent, Previously Irradiated Head and Neck Cancer: Concurrent Re-Irradiation and Chemotherapy Versus Chemotherapy Alone", Amendment 1: Patients who refuse surgery or for whom surgery is not in their best interest are now eligible; changes were made to Sections 6 (Radiation Therapy) and 7 (Drug Therapy). Please see the complete summary of changes at http://www.rtog.org/members/protocols/0421/summary_changes.html

Sites can download a copy of the protocol for IRB review by accessing the RTOG web site at http://www.rtog.org/members/protocols/0421/0421.pdf

NCI policy requires that the "Version Date" on the protocol title page reflect the date the amendment was submitted by RTOG to NCI; for clarity, the broadcast date is provided in parentheses.

Per CTMB Guidelines, amendments must be submitted and approved by local IRBs within 90 days. Expedited review is allowed; however, site IRB requirements take precedence.

Please notify your affiliates that are not on e-mail.

To share a comment or ask a question, access the Headquarters Information and Telephone Listing on the RTOG web site, www.rtog.org, under "Member Info", or call 1-800-227-5463, ext. 4189, which provides a menu to reach the Headquarters departments. If you would like to be added or removed from the RTOG broadcast list or wish to update your e-mail address, contact David Corrie at dcorrie@phila.acr.org.

Web registration is available 24/7. Information and instructions available at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html

DATE: June 15, 2006

SUBJECT: RTOG 0421 - Phase III Recurrent Head and Neck - Form Addition

The T2 Dosimetry form has been added to this study and is available on the RTOG website at http://www.rtog.org/pdf_forms.html?members/forms=0421/0421t2.pdf

Please notify your joint center institutions and affiliates who are not on e-mail.

Denise Manfredi RTOG RT Quality Assurance

DATE: November 17, 2005

SUBJECT: RTOG (0225), 0233, 0246, (0247) & 0421 PROTOCOL NOTICE: NCI/NIH Contingency Plan for Potential 5-Fluorouracil/5-FU Shortage

RTOG has received information from the NCI regarding a contingency plan for the potential 5-Fluorouracil/5-FU shortage

The Following RTOG studies involve 5-Fluorouracil/5-FU:

RTOG 0421 "A PHASE III TRIAL FOR LOCALLY RECURRENT, PREVIOUSLY IRRADIATED HEAD AND NECK CANCER: CONCURRENT RE-IRRADIATION

AND CHEMOTHERAPY VERSUS CHEMOTHERAPY ALONE"

RTOG (0247) "RANDOMIZED PHASE II TRIAL OF NEOADJUVANT COMBINED MODALITY THERAPY FOR LOCALLY ADVANCED RECTAL CANCER"

RTOG 0246 "A PHASE II STUDY OF A PACLITAXEL-BASED CHEMORADIOTHERAPY REGIMEN WITH SELECTIVE SURGICAL SALVAGE FOR RESECTABLE LOCOREGIONALLY ADVANCED CARCINOMA OF THE ESOPHAGUS"

RTOG 0233 "A PHASE II RANDOMIZED TRIAL FOR PATIENTS WITH MUSCLE-INVADING BLADDER CANCER EVALUATING TRANSURETHRAL SURGERY AND BID IRRADIATION PLUS EITHER PACLITAXEL AND CISPLATIN OR 5-FLUOROURACIL AND CISPLATIN FOLLOWED BY SELECTIVE BLADDER PRESERVATION AND GEMCITABINE/PACLITAXEL/CISPLATIN ADJUVANT CHEMOTHERAPY"

RTOG (0225) "A PHASE II STUDY OF INTENSITY MODULATED RADIATION THERAPY (IMRT) +/- CHEMOTHERAPY FOR NASOPHARYNGEAL CANCER"

Please send a copy of this information to your institutional IRB. A copy also should be retained in your protocol file.

Note: You will need "Adobe Acrobat Reader" to read the attached PDF document; this program can be downloaded free of charge at http://www.adobe.com/products/acrobat/readstep.html

- Potential 5-FU Shortage and CTEP Clinical Trials-11-16-05 [PDF]

Please notify your affiliates that are not on e-mail.

If you would like to be added/removed from the RTOG broadcast list or wish to update your e-mail address, contact David Corrie at dcorrie@phila.acr.org <mailto:dcorrie@phila.acr.org>

Please do not contact David Corrie for any other reason or reply directly to this broadcast but contact the appropriate department at RTOG HQ to share a comment or ask a question. A telephone listing by department is available on the website at www.rtog.org <http://www.rtog.org> by selecting the member info tab and clicking Headquarters Information and Telephone Listings. You may also use 1-800-227-5463 ext. 4189 which provides a menu to reach the different departments.
DATE: November 17, 2005

SUBJECT: 5-Flurouroucil (5-FU) Shortage

Because of the current nationwide shortage of 5-FU, RTOG is recommending that Principal Investigators and Research Associates check with your local pharmacist about your available supply of 5-FU before working up a patient for entry on the following RTOG studies:

0225, 0233, 0246, 0247, 0421

Current projects are that limited supplies will be available in late November 2005 and that supply will return to normal over the ensuing 2 months.
DATE: November 1, 2005

SUBJECT: Forms Revision Notice - RTOG 0421 - A Phase III Trial for Locally Recurrent, Previously Irradiated Head & Neck Cancer: Concurrent Re-Irradiation and Chemotherapy vs. Chemotherapy Alone

Forms Revision
RTOG 0421
Phase III Recurrent Head and Neck

The following form for this study has been revised. Download the new version from the RTOG web site at
http://www.rtog.org/members/forms/0421/main.html The edition code for case report forms is
found in the lower right corner of the form.

Form Type New Version Code/Date
HP Health Utility Measurement HPb   11-1-05
QOL Instructions for Investigators/RA’s   11-1-05
 
Change Made:
HP – Page 3 Institution to transcribe patient’s response for Health State.
QOL Instructions for Investigators/Research Associates – Page 2 –
Instructions included for HP form

Discard obsolete versions and commence use of the revised editions immediately.
Obsolete versions received after November 11, 2005 will be returned to the site for transcription.

Please notify your joint center institutions and affiliates who are not on e-mail.

Linda Messett,
RTOG Data Management
DATE: June 7, 2005

SUBJECT: Forms Revision Notice - RTOG 0421 - A Phase III Trial for Locally Recurrent, Previously Irradiated Head and Neck Cancer: Concurrent Re-Irradiation and Chemotherapy vs. Chemotherapy Alone

FORMS REVISION NOTICE
RTOG 0421
Phase III Recurrent Head and Neck

The following forms for this study have been revised. Download the new version from the RTOG website at http://www.rtog.org/members/forms/0421/main.html The edition code for case report forms is found in the lower right corner of the form.

Form Type New Version Code/Date
HP Health Utility Measurement HPa   6/7/05
A5 Demographic Form A5a   6/7/05
SS Head & Neck Symptom Index SSa   6/7/05
AE Adverse Event Evaluation Form AEa   6/7/05
TF Treatment Summary Form TFa   6/7/05
 
Change Made:
HP (minor revisions, updated version)
A5: Questions 2A and 2B
SS: Schema renumbered (Headquarters internal use)
AE: Schema renumbered (Headquarters internal use)
TF: Schema renumbered (Headquarters internal use)

Discard obsolete versions and commence use of the revised editions immediately. Obsolete versions received after 6/24/05 will be returned to the site for transcription.

Linda Messett, RN, BSN, CCRP

RTOG Data Management

Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html
DATE: April 27, 2005

SUBJECT: RTOG 0421, Activated

Activated

RTOG 0421, “A Phase III Trial For Locally Recurrent, Previously Irradiated Head And Neck Cancer: Concurrent Re-Irradiation And Chemotherapy Versus Chemotherapy Alone"

You may download a copy of the protocol for IRB review by accessing the RTOG web site at http://www.rtog.org/members/protocols/0421/0421.pdf

Forms for this study are available on the RTOG web site at http://www.rtog.org/members/forms/0421/main.html

Online (versus Dial-in) registration is mandatory for this study. See the link below for web registration information and instructions.

Regulatory Notes: NCI policy requires that the "Version Date" of the protocol reflect the date that the protocol was submitted by RTOG to NCI; therefore, the version date and the activation date on the protocol title page are not the same. The "Update Date" (the same as the activation date) indicates that minor administrative changes were made to the protocol after NCI approval; these changes are detailed in a summary of changes, which can be accessed at http://www.rtog.org/members/protocols/0421/summary_changes.html

To share a comment or ask a question, access the Headquarters Information and Telephone Listing on the RTOG web site, www.rtog.org, under "Member Info", or call 1-800-227-5463, ext. 4189, which provides a menu to reach the Headquarters departments. If you would like to be added/removed from the RTOG broadcast list or wish to update your e-mail address, contact David Corrie at dcorrie@phila.acr.org.

Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html