RTOG: Committee Minutes - CCOP Principal Investigators

Committee Minutes- CCOP PI

CCOP PRINCIPAL INVESTIGATORS COMMITTEE (June, 2002)

Lawrence Berk, M.D., Ph.D., Chair

A presentation was made to Sophie Turner, M.D. by Walter J. Curran, Jr., M.D. in recognition of her service as Chair of the CCOP PI Committee and to the RTOG. All present joined in congratulating her. Dr. Lawrence Berk was then introduced as the new Chair.

The CTSU staff gave a presentation on the mechanics of participating in trials through the CTSU, and on how to put trials into the CTSU system.

Open Trials

RTOG 99-01 – A GM-CSF study for head and neck mucositis is accruing well and should close this year.

RTOG 99-03 – An erythropoeitin study for head and neck anemia continues to have problems accruing. An advertising campaign is to be started to help increase enrollment. The difficulties with the radiation schemata were also reviewed, but there are no changes planned.

RTOG 97-14 - A bone metastases trial is close to completing accrual and should close in the next few months.

Proposed Trials

RTOG 1042 - A trial using Carafate for prevention of radiation procititis. The manufacturer of Sucralfate has withdrawn support. DCP has not voice strong support for this concept. Therefore this has been withdrawn as an active development item.

RTOG 1026 – A trial using Octreotide for prevention of diarrhea. A final protocol has not been submitted to the RTOG. The chair will contact Dr. Zachariah.

A proposed trial for Pentoxifylline and Vitamin E for late GI Toxicity: Dr. Okunieff has not submitted a protocol. The Chair will contact him to determine if this is to remain an active protocol concept.

A proposed trial for Glutamine for prevention of acute abdominal irradiation morbidity. Dr. Yeatman of the Harvard Joint Center presented a trial proposed by him and Dr. Seider to use Glutamine for prevention of acute abdominal irradiation morbidity. Dr. Berk presented (on behalf of Dr. Charles Thomas of the San Antonio Cancer Institute) a similar trial on the use of omega-3-fatty acids for the same purpose. Both trials needed clinical data to support the concept before it could be taken into the protocol stage. Dr. Seider noted that there is a current SWOG protocol using Glutamine for prevention of head and neck mucositis. Background data may be available in this trial. Both groups (Glutamine and omega-3-fatty acids) will contact the chair with the available clinical data and he will then discuss with the DCP representative to determine if this is enough to proceed with protocol development.

Radiation Mucositis options were reviewed by Dr. Scarantino. He discussed our previous musositis and xerostomia trials and where we could go to in the future. KGF does not appear to be viable. GM-CSF is undergoing continuing testing. The use of a GM-CSF mouth rinse looks promising but the drug availability is uncertain. Traumeel is a homeopathic preparation showing promise in chemotherapy trials but there is little or no clinical data in radiation therapy. Dr. Berk will pursue obtaining clinical data and protocol development for Traumeel. Dr Scarantino has proposed developing a limited participation Phase II trial of subcutaneous Amifostine and oral Pilocarpine for patients undergoing head and neck radiation. It is being designed as a limited participation trial because the medications may not be available without cost.

RTOG 02-26 – A study using Celebrex for head and neck chemoprevention was discussed. Concerns over the high dose of Celebrex (800 mg) were discussed. However, this is the dose used in the present cervical cancer trial (C-0128).The final protocol has not been received and the protocol will continue in development.

RTOG 1017 – A developing study using Strontium and IL-11 is at the NCI for review.

RTOG 1053 – A developing study using Samarium and biphosphonates for bone metastases is at RTOG Headquarters for statistical evaluation.

RTOG 1061 – A developing study using Captopril for prevention of radiation mucositis is at the NCI for review.

RTOG 99-10 – This is a add on to this trial using Viagra® for erectile dysfunction after radiation therapy and is at the NCI for review.

Current Activities of the Integrative Oncology Committee

BR-0119 – Melatonin for Brain Metastases has opened for accrual.

M-0122 - Juven for Cancer Cachexia is to be submitted to the NCI within a few weeks for approval.

RTOG 02-20 – A study using Ukrain for Pancreatic Cancer has been approved by the GI Committee and is to be sent to RTOG to be prepared for NCI submission.

Dr. Berk then briefly discussed using Yahoo Groups website for the CCOP PI Committee as the focal point for protocol development. This may allow more participation in the protocol development process while decreasing the development time. He will develop several trials with this site to see if it can be implemented successfully.

CCOP PRINCIPAL INVESTIGATORS COMMITTEE (January, 2002)

Sophie Turner, M.D., Chair

The meeting opened with an overview by Dr. Charles Scarantino. He announced that the Cancer Control Program had again contributed significantly to the overall patient accession with over 600 patients placed on cancer control studies in the last year. There was then a Cancer Trials Support Unit (CTSU) presentation by Detra Robinson, Project Manager of Westat. This is the firm, which manages the CTSU program. The goals of CTSU and the operation were described. It was made clear that the CTSU represents a vehicle for patient accession by a variety of groups. Questions regarding IRB approvals were raised and the concerns regarding this will be elucidated at a future meeting.

The next part of the program dealt with past, current and future cancer control studies.

I. GI STUDIES

Closed

RTOG 98-09

Approved Concepts/Protocols

RTOG 10-42

RTOG 10-26

II. HEAD AND NECK STUDIES

Current Studies

RTOG 99-01

RTOG 99-03

RTOG 99-13

Proposed Concepts

III. BONE METS

Open Studies

RTOG 97-14

Approved concepts/ protocols

RTOG 10-17

⁸⁹

IV. LUNG

Open Studies

RTOG 98-01

Proposed Concepts

RTOG 10-61

V. BULKY TUMORS

RTOG 10-76 - Spatially Fractionated Radiation (SFR) for the study of conventional radiation combined with dose escalation for bulky tumors. Dr. Mohiuddin presented the concept. The objective is to deliver radiation for bulky disease not responding to conventional treatment for palliation of pain, bleeding and quality of life. Patients would receive 1500 cm using SFR. There was a discussion regarding utilizing this modality for palliation rather than definitive treatment and likely keeping the conventional dose to 3000 post SFR. There was approval by the CCOP’s to develop this as a study. An applicator which would be required for this treatment, which cost approximately $2,000 to $3,000, and so participation would be voluntary. It was recommended that this be presented at research strategy to determine its status as a cancer control verse treatment protocol.

Integrative Oncology

Dr. Berk presented on the following studies:

1. RTOG 10-05- Nutritional intervention with Juven. The concept has been approved and requires minor modifications and will be resubmitted to the NCI

2. RTOG 10-06 - Ginseng for Fatigue. The studies are at headquarters and will be finalized for submission to NCI for review.

3. RTOG 10-70 - WOBE-Mugos for Mucositis in Head and Neck was withdrawn due to lack of support by the company.

The cancer control program is completing a number of studies and replacements are underway. We look forward to a number of new and exciting studies.

CANCER CONTROL PROGRAM (May, 2002)

Charles Scarantino, M.D., Ph.D., Chair

The meeting began with a discussion of the Cancer Trial Support Unit (CTSU) by Detra Robinson. The presentation was well received including pertinent questions regarding the Central IRB. Currently there are 22 CALGB sites that have signed up. The goal is for 100 sites.

CCOP-Current Studies

Chuck Scott began with an update on the Current Studies. RTOG 97-14 is accruing well and should be completed this year. RTOG 99-13 is also accruing well and should be completed by April of 2002. RTOG 99-01(GMCSF for H&N) has approximately 50% of the projected number of patients.

CCOP- Approved Concepts

Dr. Movsas presented discussion of Carafate for GI Toxicity, including a current study that reported rectal bleeding but decreased late rectal toxicity and bleeding. The concept was approved as presented.

Dr. Zachariah presented Octreotide for CT/RT induced diarrhea. There was a significant discussion on stratification, which will include site, chemotherapy and field size.

Dr. Okunieff presented a new concept of Pentoxyphyline and Vitamin E. There were several questions regarding the use of placebo, providing drug and cytokine levels.

Dr. Hartsell presented a new study for re irradiation for bone Mets. This will be an international study. There was no indication who will run the study. There was also discussion on the treatment schedules for re irradiation.

Dr. Mohiuddin presented a study for Spatially Fractionated Radiation. The suggestion was that this should be for palliation and not include patients considered for definitive therapy. It was suggested that it be developed as a randomized study for 300x10 +/- SFR.

Integrative Oncology

Dr. Berk presented study on Traumeel for mucositis. This concept was presented to him based on results obtained from patients undergoing transplant. The patients experience less mucositis while on Traumeel. This was presented as a possible replacement for the GM CSF study.

Chemoprevention

Not present.

CCOP PRINCIPAL INVESTIGATORS COMMITTEE (November, 2001)

Sophie Turner, M.D., Chair

There has been no change in the leadership and the CCOPs have continued to accrue rapidly to the open studies.

I. Closed studies:

1. RTOG 98-09 - PPS for GI toxicity closed in March 2001. There were 181 patients entered. It had been planned to continue the study however due to unavailability of the drug, the study was stopped at the originally planned patient number. The study will be analyzed as soon as the data is available and a plea was made to data managers to submit data for patients on this study as soon as possible.

II. Current studies:

1. RTOG 97-14 – Palliation for bone mets. This study is accruing well and will most likely close within the year. Dr. Hartsell, the study chair, clarified that patients are eligible if they are on systemic therapy and systemic therapy can be changed while they are on study. However, if the patient’s systemic therapy stopped while they were on this study they would become ineligible. A plea was also made for more institutions to participate in the economic impact portion of the study, which was a voluntary. The institutions which initially elected to participate in this portion of the study accrued only 30 patients thus far. This makes it difficult to make any meaningful analysis.

2. RTOG 98-01- Non-small cell lung Amisfostine. This study is at the halfway point and accrual has picked up since a positive presentation at ASCO for Amifostine. Dr. Movsas reminded the investigators that each case gets two credits on this study. Pleas were made to speed up accruals to complete this study as soon as possible.

3. RTOG 99-01 - GMCSF for Head and Neck Cancer. This study is accruing slowly. Only 17 patients have been entered out of the required 126. A plea was made to increase accrual so that this study so that it can be completed promptly to allow for the start of new proposed studies.

4. RTOG 99-03 - Erythropoietin for Head and Neck Cancer. This study is also accruing slowly and so far only 19 patients have been entered. A limitation in the accrual is the fact that only patients receiving radiation therapy are eligible and the current practice to combine chemotherapy with radiation in a large number of tumor sites. Dr. Machtay is working with NCI headquarters in attempt to broaden this study to include with concurrent chemotherapy.

5. RTOG 99-13 – Biafine ® for skin in Head and Neck cancer. This study is accruing very rapidly and as of June 1^st, 125 patients have been entered out of a proposed 498 patients. Patients being treated with IMRT are eligible.

III. Approved Concepts / Protocols:

1. RTOG 1061 – Phase II Study. Captopril for lung sequelae post radiotherapy. Revisions have been made in this protocol as recommended by the NCI and the document is now at headquarters being prepared to be resubmitted to NCI.

2. RTOG 1017 – Phase III Study. Interleukin-II for thrombocytopenia in symptomatic bone mets treated with Strontium ⁸⁹. This study is at headquarters and will be submitted to the NCI for approval.

3. RTOG 1042 – Phase III Study. Carafate for GI sequelae following RT for prostate carcinoma. Dr. Movsas is completing the protocol and the study will be submitted to NCI.

4. RTOG 1050 – Phase I/II Study. Bisphosphonates with and without Samarium 153 for asymtomatic bone mets. To evaluate toxicity, survival and time to symptom development. Dr. Seider is writing the protocol.

IV. Proposed Concepts

1. Sandostatintatin LAR Depot Phase III Study for the Prevention of Radiation Induced Diarrhea. This was presented by Dr. R. Danner from Novartis and will replace a previous concept for utilizing Metamucil for GI toxicity. The principal investigators for this study will be the same as those for the Metamucil concept. Sandostatin is similar in action to Somatostatin. It inhibits release of serotonin and decreases intestinal motility and bile secretions. It is long lasting and has been used effectively in chemotherapy induced diarrhea. Mode of delivery is either sub-Q or IM. The aim is to decrease incidence of diarrhea, enabling the course of treatment of carcinoid and certain leukemia’s without tumor protection and, therefore, it is felt that protection of other tumors is unlikely. The study will include patients on chemo and radiation regimens, undergoing study will include patients on chemo and radiation regimens, undergoing treatment for rectal cancer. The concept was approved for development and also to be presented to the GI, Quality of Life and Outcomes Committees.

2. NESP for anemia in CA prostate. Presented by Dr. Valicenti. This is “novel erythropoietin” and the study is for patients who develop anemia while on neoadjuvant hormonal therapy prior to radiation therapy. It is anticipated that the incidence may increase with more widespread use of pelvic radiation for treatment of CA prostate. Toxicity and Quality of Life issues as well as increase in hemoglobin would be endpoints. Modifications to the concept were recommended and the concept should then be presented to the CCOP committee for further review and would also need to be presented to the Outcomes, GU and Quality of Life committees.

V. Integrative Oncology

1. RTOG 1005 – Phase III Nutritional Intervention with Juven. The study is being resubmitted for NCI with revisions.

2. RTOG 1006 – Phase III Study of Ginseng for Fatigue. This study will be sent to NCI for review shortly.

3. RTOG 1070 – Phase III Study of WOBE-Mugos for Mucositis in Head and Neck. Will also be sent to NCI.

With the approval of Research Strategy Committee, the name of the Complementary and Alternative Medicine Subcommittee has been changed to Integrative Oncology Committee. The Committee continues to explore other areas of possible research such as acupuncture and relaxation hypnosis and to also look at other botanicals for development of future concepts.

In conclusion, the Cancer Control Program continues its goals of active participation in current protocols and of developing novel studies to improve quality of life as well as outcomes in patients undergoing cancer treatment.

CANCER CONTROL COMMITTEE (November, 2001)

Charles Scarantino, M.D., Ph.D., Chair

The program was initiated with an overview of the Cancer Control Program in general. Which it was emphasized that particular areas would be targeted to build upon the results of the previous studies. In particular, the results of RTOG 97-09 Pilocarpine showed significant improvement in the salivary flow following Pilocarpine. In addition as will be obvious from today’s discussion, there is increased interest in investigating the GI toxicities secondary to radiation therapy and chemotherapy. Secondly, Dr. Turner reviewed the CCOP studies including: (a) RTOG 98-09, PPS for GI toxicity was has closed. (b) Dr. Hartsell presented a review and update on RTOG 97-14. (c) RTOG 98-01 was discussed by Dr. Ben Movsas. This is looking at Amofostine to address the problems with esophagitis, and the activity is improving. d) RTOG 99-01 GMCSF was briefly discussed with regard to accrual. This has been lagging and hopefully this will improve. The RTOG 99-03 with Dr. Machtay has been open but is accruing slowly at this time. RTOG 99-13 Biafine® for skin reaction in head and neck patients is accruing very well. There were a number of patients placed on this past month. The third part was approved concepts and protocols - RTOG developing studies included 1061 for lung which is currently with Dr. Small - RTOG developing study 1017 which is with Dr. Seider and 1042 with Dr. Movsas are almost complete. The fourth part of the session discussed proposed concepts. 1) Metamucil for GI toxicity by Dr. Zachariah was withdrawn and in its place Dr. Dana discussed the use of octriotide for the prevention of chemo-radiation induced diarrhea. Octriotide is a somatostatin was discussed with regard to background and current information, including the incidence of diarrhea in patients receiving chemotherapy and a small study which was introduced with regard to chemo-radiation. The incidence is significant and does warrant a study of on intervention for the amelioration of GI toxicity. Primarily the discussions revolved around the inclusion of both radiation and chemotherapy. In addition, it was felt that this should be used only for GI malignancies and not Gyn malignancies. It was felt that there should be some consistency with regard to the type of chemotherapy that is being used and therefore we should stratify accordingly. In addition it was recommended that CT scans and treatment planning simulation films be obtained and sent to headquarters for evaluation upon the completion of the study to determine the incidence of diarrhea based on the volume of intestines included in the field. There were also some discussions about the run in period with regard to octriotide and it was felt that since patients do not experience diarrhea within the first two weeks that a run in period would be acceptable. This would be used for pre-op and post-operative patients. Finally an economic impact study was felt to be feasible and should be included. Second the NESP (novel erythropietin stimulatory protein) was discussed by Dr. Valicenti. It was indicated there was usually a fifteen percent incidence of reduction in hemoglobin in patients receiving total androgen suppression. This was less than twelve grams. The endpoint would be to study the fatigue associated with depressed hemoglobin. After some discussion it was felt that there was need for further information in order to indicate the incidence of the anemia as well as the timing of the administration of the NESP. The third study that was discussed was vitamin E for late effects associated with GI toxicity. This was discussed by Dr. Okunieff. The endpoint would be a decrease in symptoms. The secondary endpoint would be the evaluation of the cytokine levels. This is the first study presented by Dr. Okunieff with regard to the cytokines associated with GI late effects. Finally a study on the spatially fractionated radiation therapy utilized in a group for a palliation of bulky tumors within seven centimeters. The proposal was to evaluate the group therapy plus dose escalation. After some discussion it was felt that we should consider a randomize study versus a dose escalation. One of the problems is the purchasing of the grid for each institution that wishes to participate in the study. The endpoint of this would be palliation.

The committee for complimentary and alternative medicine (CAM) was reintroduced as the interactive oncology program and was discussed by Dr. Larry Berk. 1) RTOG developing study1005 the Textixia study is in progress as well the developing study 1066 the fatigue study for ginseng. The RTOG developing study 1070 for Mucositis was also discussed by Dr. Berk.

Late Effects -

Dr. Okunieff chaired this section and introduced the proposal for a LENT IV conference to be held in Clearwater, Florida (March 1st-3^rd 2002). This will be to study the science of late effects including markers associated with late effects and also an integration of the acute toxicity with chronic toxicity scales. The proper papers would be accepted at this time.

Finally chemo prevention was discussed by Dr. Curry who brought us up to date on the several studies as far as their status. The will proceed as planned. In addition he continues to work the surrogate tumor markers, particularly with prostate, and will be looking for new areas that will consider surrogate markers.

We will continue to emphasize the activities of the Cancer Control Program and we look forward to the opening of several new studies within the next six months. We feel confident that this can be achieved. In addition we will make every effort to consult the different site committees with regard to new studies effecting the various primary site committees.

CANCER CONTROL PROGRAM (June, 2000)

Charles W. Scarantino, M.D., Ph.D., Chair

The meeting was initiated with an overview with the Cancer Control Program and the current status of the grant as well as the funding. The grant received a high score on review and funding results will be forthcoming. The meeting was initiated by Dr. Turner who is the CCOP PI and she did call on Dr. Scott to review some of the closed and current studies. For the current closed ones the results will be forthcoming include RTOG 96-04 and 97-09. He did report that RTOG 96-07 was submitted in abstract form and was rejected by ASTRO. In addition to the current studies we have one open and that is RTOG 97-14 a bone mets. This was sent to the Data Monitoring Committee and they requested that it be kept open. It currently has 449 patients. The non-small cell lung Amofostine study by Dr. Movsas was presented briefly and the accrual has increased. RTOG 98-09 PPS by Dr. Pilepich is on temporary hold for lack of packaged agent. RTOG 99-03 should be open by the end of June. The Biafine ® review has been received from NCI and will be sent down a third time. RTOG 1045 is still at the NCI. Dr. Berk then reviewed the complementary and alternative medicine studies and presented several studies including RTOG 1025 and 1026, Ukraine and Helixor. There was good discussion regarding the mechanisms of these agents and whether they are known and that they should be brought up. It was requested that these be presented to the Medical Oncology Committee for further discussion. In addition the head and neck for mucositis was also discussed. Following this Dr. Khuri discussed briefly the chemoprevention studies including the alphatocopherol plus 13 Cis Retonic Acid that will be presented to the committee. In addition, Dr. Zachary presented a study on Metamucil and there were questions regarding the mechanisms for action of these drugs and whether there has been any published information. There is no published information but this has been presented in abstract form. There was concern that we need more information so that Dr. Zachary will gather this over the next several months and present it at our next meeting. Dr. Scott then presented the Gore study, which involves patients with NSCC over 70 years old treated with 3 Gy per day (15 fractions) plus Taxol. Dr. Langer presented this study and there was discussion regarding this approach because of the concern for the toxicity associated with 4500 in three weeks plus Taxol. The recommendations were made and we will look at this in more detail. There was interest that this might receive half a case credit for cancer control. Dr. Khuri then presented a protocol from Dr. Shin for 13 Cis Retonic Acid plus Interferon. There was concern that this might be an adjuvant study rather than a cancer control study.

The last study discussed was a double blind study for patients with prostate cancer following post external beam radiation therapy. The proposal was for low and intermediate risk prostate cancer patients to be randomized to Selenium versus placebo. The main concern was how to distinguish recurrence from new primaries. The group felt that this distinction was not solid enough and that we need more information regarding this distinction. One suggestion was that the patients be placed on this study at a later time.

Finally the last section was Late Effects and Dr. Rubin was introduced. He discussed the overview including RTOG 96-04, which has been closed and will be evaluated in the near future. In addition the SOMA scales will be utilized in brain, lung and prostate patients. Also he discussed the program including pediatrics using SOMA. Dr. Okunieff gave a brief introduction regarding Cytokine cascade that the SOMA scales are trying to identify to determine which patients go on to Late Effects. He presented some evidence which indicated that the KGF Cytokine might protect the GI and bone marrow. The study was suggested utilizing KGF for treatment of GI toxicity and utilizing the LENT SOMA scales. This would be in patients who are two years NED with colorectal or prostate cancer that have measurable toxicity using LENT scales. These patients would then have an evaluation by LENT scales plus blood work for Cytokine studies and then receive the drug, KGF weekly, for two months and then be reevaluated with the LENT scales. The non responders then would be taken off study and the responders would then continue on weekly for four months. This did generate some discussion, which was thought to be an excellent study. This will be developed over the next several months and presented in full form at the next RTOG meeting.

CCOP PRINCIPAL INVESTIGATORS COMMITTEE (January, 2000)

Sophie Turner, M.D., Chair

The meeting was opened with a preliminary announcement that the CCOP grant has been renewed by the NCI with a good score. Further details will be forthcoming shortly. There has been no change in leadership since the June meeting

CURRENT STUDIES:

RTOG 97-09 – Pilocarpine for head and neck. The study opened 3/17/98, and will have completed accrual at the end of January. A total approximately 244 will have been entered.

RTOG 97-14 – A phase III bone mets study. The study is accruing well at a monthly rate of approximately 20. It has accrued a total of almost 366 patients and at the current rate of accrual will complete in April 2002 with a total of approximately 938 patients. Eligibility criteria will be changed to allow entry of patients whose systemic therapy has changed within 30 days of randomization. Patients who have not been on systemic therapy, however, may not start new treatment for 30 days prior to randomization.

RTOG 98-01 – A phase III study of Amifostine for esophageal protection for favorable inoperable non-small cell carcinoma of the lung receiving chemotherapy and radiation. This study opened 9/8/98 and to date accrued approximately 70 patients. Average monthly accrual has increased in the last six months to 6.0 and at this rate projected date of completion is April 2003.

RTOG 98-09 – A phase III study of PPS in treatment of gastrointestinal tract sequelae of radiation. This study opened on 6/14/99. It is accruing well at almost 7 patients per month for a projected date of completion August 2001 with 174 patients required.

APPROVED STUDIES:

RTOG 99-01 – GM-CSF for mucositis in head and neck cancer. The study has been approved by DCPC and is pending IND approval. It is hoped that this study will be activated soon.

RTOG 99-03 – A phase III study of Erythropoietin on locoregional control in anemic patients with head and neck cancer. There will be a quality of life component. Patients on chemotherapy and Amifostine will be excluded.

RTOG 99-13 – A phase III study of Biafine ® for skin toxicity in curative radiotherapy of head and neck cancer. The study has been resubmitted to DCPC.

RTOG 1017 – A phase I/II study of rhIL-11 for prevention of Thrombocytopenia in bone mets treated with Strontium⁸⁹. The endpoints will be Thrombocytopenia and pain control. This study will exclude patients eligible for RTOG 97-14. It will open later this year.

RTOG 1045 – A phase III cross over trial of Viagra post treatment for carcinoma of the prostate. The protocol will be submitted to the NCI after the meeting. A total of approximately 300 patients will be required.

A study of Carafate during CRT for carcinoma of the prostate to prevent late GI toxicities was discussed and approved for development by the CCOP’s. Dr. Movsas will write up a concept which will be circulated

COMPLEMENTARY AND ALTERNATIVE MEDICINE:

1. RTOG 1005 – Randomized study of targeted nutrition utilizing Juven for patients receiving palliative radiation/chemotherapy who have lost in excess of 5% of body weight. Patients with lung, breast and prostate cancer will be eligible. Muscle mass will be measured to assess response. There will be a QOL component.

2. Phase III study of Ginseng for fatigue in patients undergoing radiation therapy for lung, prostate and breast cancer. Patients will be stratified according to hemoglobin level. There will be a quality of life component. The concept was approved for further development.