Committee Minutes - VA/MTF Meeting VA/MTF MEETING (January, 2008) Patrick Tripp, M.D., for Roger W. Byhardt, M.D., Chair Group Administrator Report - Mr. Tom Wudarski Funding and Grant Renewal - Tom Wudarski Funding for RTOG VA/MTF supplemental grant (S) is planned as continuing program within overall RTOG budget. The budget is due February 1st Supplemental Grant for VA/MTF Committee likely to be awarded Accrual - Tom Wudarski 109 VA/MTF patients accrued to RTOG trials in 2007 Uncertainty about accrual credit - Dr. Spring Kong from the Ann Arbor V.A. suspected patients enrolled were credited to the University of Michigan. But Ann Arbor V.A. clinical research R.N. clarified in fact patients were credited to Ann Arbor V.A. Other Questions - Technology, Clinical Trials, Reimbursement Rules Persistent problems with firewall or other security technology were described. Tom Wudarski recommended contacting ACR Information Technology Director, Hank Brasteter who can be contacted at hbrasteter@acr-arrs.org A question was raised about V.A. IRB regulations especially with tissue and blood specimens. Jean Stern, who is the Clinical Research Associate from Milwaukee V.A., described experience of no IRB problems if specimen sent to centralized pathology review site such as LDS hospital. Dr. Kong from Ann Arbor asked about RTOG-funded studies for V.A. patients only. Tom Wudarski described the RTOG funding priority system. V.A. patient accrual represents approximately 3% to 4% of total RTOG accrual, and V.A.-specific study would not be cost effective. The prostate study run by Dr. Mike Hagan at Richmond V.A. - clinical research R.N. from Richmond V.A. gave update, no new patients enrolled on the study, and the study has not been expanded outside Richmond V.A. Question about RTOG reimbursement for V.A. patient treated off-site (for example at adjacent medical school or other setting) - which site is eligible or not eligible for funding? Tom Wudarski answered and stated the amount of money requested in supplemental grant will not change. RTOG reimbursement can be to the radiation oncology department delivering the treatment, even if department is not in the V.A. hospital. Announcements from the RTOG VA/MTF Committee Chair Patrick Tripp, M.D. covering for Roger Byhardt, M.D., who was not able to attend the meeting) Peer review program development continues. Peer review goals include chart review between V.A. radiation oncology departments, including review of technical information about the chart such as correctly recorded stage and diagnosis. Initially the peer review program will be limited to radiation oncology departments within V.A.'s, and would not include review of V.A. patients treated off-site (for example at adjacent medical school or other setting). A Director of Radiation Oncology for the V.A. has been named and will be announced soon. VA/MTF MEETING (February, 2007) Patrick Tripp, M.D., for Roger W. Byhardt, M.D., Chair Group Administrator Report - Mr. Tom Wudarski Tom state the RTOG competing grant renewal application has been given one-year hiatus because of the loss of RTOG Group Statistician Dr. Suzanne Swann. The grant would be year 32-S (supplement). RTOG does not know what to expect from NCI funding. RTOG was asked to develop 12% reduction in budget. Consequences of 12% reduction in budget may include case reimbursement compromised and even requirement to reduce staff. RTOG has been asked by NCI to give list of studies and concepts to close. Tom Wudarski continued by saying 2007 does not look promising. But cuts represent reflection of cuts across federal government. For RTOG 6-year award, grant funds cannot be collected beyond 6 years. Seventh (S? supplemental) year represents indirect cost reimbursement from ACR Entire cooperative group support is approximately $170 million. Tom Wudarski is hopeful that actual decrease in budget for current year would be in range of 3% to 5%. IAA ? Dr. Michael Hagen recommended one solution would be request VA to provide a VA. CRA. Another recommendation was industry could support VA trials and increase accrual. Tom Wudarski described 2007 notice of grant would not be until March, and was projected at 80%. Tom described challenges of management with personnel and protocols. Tom pointed out SWOG had closed its H&N committee. He pointed out RTOG may need to consider closing its "borderline" committees such as Sarcoma, GYN and Breast. This raises the question what would happen when partial breast RT study closes? Report from Dr. Michael Hagan Update of phase II study ? open 1.5 years, 12 patients enrolled at Richmond. Results include no dramatic increases in PSA, testosterone levels of only a few patients higher than castration levels. Richmond cohort (12 patients) shows men can go 18 months without goserelin. Pharmacy at Richmond was able to show a noticeable decrease in spending. VA mechanism for clinical grants ? pilot study that central VA might agree on for example return to goserelin treatment when PSA > 10 or some threshold level (10 was the level used in the two published trials studying this question). On or off LHRH agonist does not appear to change permanent-castration (2-year LHRH agonist) patient outcomes. Richmond anticipates 15 to 20 patients on the study. As rate of PSA failure decreases and salvages treatment is not required, pool of potential recruits becomes smaller. Other participants at VA/MTF meeting talked of a PSA threshold other than 10. For example the urology service at Lackland AFB had concerns about 10. And Jean Stern (not at meeting but Vicki Skinner from Richmond described Jean's concerns) they are concerns about 10 as threshold and concerns about cost of obtaining serum testosterones on patients in the study. Mike Hagen said that serum testosterone should be added to routine evaluation of these patients as standard of care, on or off study. Notes about V.A. Equipment Purchases and VA/MTF Group $75 million spread over 25 centers. Examples of purchased equipment included trilogy system, brain lab, 90 cm bore simulator. VA/MTF committee should campaign for good turnout at RTOG meeting in Philadelphia June 2007. Mike Hagan pointed out something should come out of VA/MTF participation in RTOG. With new equipment we need to show VA's are able to put more patients on trials (part of rationale for new equipment was that old equipment did not meet technological requirements of RTOG studies). Notes on Clinical Trials VA needs a study open for Stage III NSCLC patients. VA needs studies open for all prostate ca patients ? from low-risk to high-risk, and soon-to-open RTOG study for post-op prostate patients would give additional opportunity to enroll VA patients. Based on cost of living estimates in Richmond Virginia, annually 27 patients on phase III studies (based on RTOG reimbursement rates) would be needed to pay salary for a CRA. Other Topics of Interest Encourage turn-out at June RTOG meeting. Ways to encourage turn-out would be identifying VA sites that have made equipment purchases and especially encourage them (again, if rationale for new equipment was "we need the equipment in order to participate in trials," the equipment is now being installed). ACRO accreditation visits ? photos to document equipment and employees, chart review. VA/MTF MEETING (January, 2005) Roger W. Byhardt, M.D., Chair The VA/MTF meeting convened at 10:30 AM and was attended by 12 VA/MTF members and staff representing 8 institutions. Tom Wudarski reviewed the status of the supplemental grant and noted it continues in force until the 2007 grant renewal. It still provides an additional $600 per case accrued. It also supplies travel funds for VA/MTF MD’s and staff. There are a fixed number of travel slots, but we want to encourage more attendance at the meeting, especially for data managers. Tom will work out a system of reminders to be sure there’s good attendance from the CRA’s. Contacts at the meetings are potentially very helpful. VA/MTF accrual continues to fall off and mirrors the fall in overall RTOG accrual, related to a decrease in available large Phase III studies that have eligibility that matches the VA/MTF population. There are multiple other causes of the accrual drop off and these have been detailed in the NCI annual report. Some may not be correctable until the grant renewal and other require VA action at a national level outside of control of this group. VA/MTF accrual for 2004 was 96 cases, representing 5.5% of the overall RTOG accrual of 1726 cases. The drop reflects the absence of a large Phase III prostate cancer trial and also an appropriate head and neck cancer trial. Some less complex CCOP trials have begun to “take up the slack”. Other causes of accrual fall off discussed included increasing trial complexity, persistent weakness in the VA research infrastructure, mismatch of studies and the VA population and IRB issues. Some new trials require RT technology not yet available in the VA hospitals system. Other new trials employ new chemotherapy and biologic agents are more costly than the agents considered “standard” by the VA and there are insufficient funds budgeted to the VA pharmacies to cover drug costs in the trials. Some VA’s are expecting the RTOG investigator to pay for these costs out of case accrual funds, which are obviously inadequate for the purpose. In this regard, the VA has reneged on its Interagency Agreement with NCI to provide for the costs of conducting research in the VA. As such, veterans are being denied access to RTOG trials, since the trials cannot even be activated without these costs being covered. The veteran population also has more comorbities that make it difficult to meet study eligibility requirements. More studies are needed that address the issues faced by the VA “real world” population. Some VA IRB’s are charging up to $1,500 to the investigator for initial trial review. Again, these funds are not available out of case accrual funds, so accrual is essentially stopped. Mike Hagen reported on the status of the Phase II hormone cessation trail for PSA failure patients that have been on LHRH agonists for 2 years or more. The study has been approved by the Genitourinary Cancer Committee and Dr. Hagen’s statistics office at MCV has kindly completed the statistics section. Thus, the trial is ready to activate soon and will be open to all VA/MTF’s for accrual. There should be little difficulty getting 50-60 patients accrued in short order so that we can collect pilot data. It could lead to a future group wide study. Dr. Byhardt discussed the recent activities of the VA Oncology Field Advisory Committee (VAOFAC). The M-9 document (VA Criteria and Standards for Oncology Care) is completed and awaits sign off by VHA HQ (Dr. Holohan). This document specifies space, personnel and equipment standards for VA Oncology programs. Dr. Byhardt has been delegated to help develop site-specific consent forms for use on the VA computerized medical record system (CPRS). Patients would be able to sign these electronically using a device similar to that used in stores for signing credit card purchases. A contract between VA and ACR for ACR accreditation site visits to all in-house VA radiation oncology facilities has been hung up in VA national contracting office in DC. Work is ongoing to implement a software package that can link LANTIS and IMPAC to the VA CPRS system, with still multiple compatibility problems to solve. Lack of IMRT capability in VA’s has hamstrung entry onto such trials, but a plan is being considered to establish IMRT at regional VA sites. The Interagency Agreement has just been renewed between VA and NCI with essentially no change in the language. Dr. Byhardt and Tom Wudarski will be in contact with Andrea Denicoff at NCI who is in charge of NCI’s end of the agreement. Dr. Byhardt will be discussing the agreement further at the upcoming VAOFAC meeting in Cincinnati in April. VA/MTF MEETING (June, 2004) Roger W. Byhardt, M.D., Chair The VA/MTF members met 6/26/04 from 10:30AM to 12:00NOON. There were fourteen attendees representing 7 VA/MTF facilities. Tom Wudarski presented the update on the NCI supplemental VA/MTF grant. He noted the supplement is a permanent part of the RTOG grant and is in place until the next grant renewal in 2007. Accrual from VA/MTF’s was 207 for 2001, 143 for 2002 and 129 for 2003. This downward trend continues in 2004, with 47 accrued through this meeting; this project to an accrual of 90 to 100 for 2004 if nothing changes. The reasons for the accrual decrease over the past 2 years were discussed and, in general, the issues effecting accrual seem to reflect the effect of circumstances outside the control of the VA/MTF members. The significant issued effecting accrual can be summarized as follows: Closure of major phase III prostate cancer studies accounted for the majority of VA/MTF accrual. (e.g. RTOG 99-10, 99-02, etc.) and slow activation of replacement study RTOG 0126. Activation of RTOG 0126 requires credentialing of the dosimetry process for 3D conformal therapy. VA’s who have not previously done this have found this to be an obstacle especially if they don’t have adequate dosimetry personnel. Delays in activation by the RTOG GU committee of the prostate cancer protocol proposed by the VA/MTF group (Dr. Hagen) to evaluate cessation of prolonged duration LHRH therapy. Dr. Hagan was not present at the meeting to report on the status of the prostate cancer hormone cessation protocol the VA/MTF committee had proposed to the GU committee. Availability of an accrual friendly trial such as this may be another means by which to increase accrual. Dr. Byhardt will attend the GU committee meeting and follow up on the status of this study. VA administrative and clinical research program issues: Changes in patient consent procedures and patient data privacy regulations in the VA IRB process related to compliance with HIPPA regulations (activated 4/03). VA clinical research stand-down, which was implemented from 4/03 to 7/03 suspended or delayed accrual and new study activation. New NCQA oversight of VA IRB’s slowed/delayed VA IRB approval process for new studies. Issues related to lack of compliance of individual VA’s to the Memo of Understanding (MOU) between NCI and VHA that states that VA will cover the infrastructure research cost of NCI sponsored clinical research (e.g., drugs, supplies, imaging, labs, IRB approval costs, etc.) with no charge to investigator or patient. NCI reimbursement is to cover only the cost of data management and travel to the closest group meetings. Some VA IRB’s now require up to $1,500 per study for initial approval of an RTOG study and $500 for each annual renewal. The per case reimbursement from RTOG cannot cover this cost. The MOU indicates the cost of IRB review is to born by the VA. Several VA’s have been unable to activate new RTOG trials (e.g., RTOG 0247; preoperative chemo radiation for operable rectal cancer; RTOG 0234, (postoperative chemo radiation for head and neck cancer), because the VA pharmacy will not cover the cost of the study drug. In the RTOG 0247 trial, the VA in question would not pay for Oxaliplatin because of its cost in comparison to 5-FU, ruling it was nonstandard treatment and the research reimbursement should cover the costs. For RTOG 0234, the Taxotere cost could not be covered for the same reason. The Philadelphia VA, a major accruer of about 15 patients per year, lost its affiliation with the University of Pennsylvania and dropped out of RTOG. There was then discussion regarding possible solutions to these problems, including the following: 1) Addressing the MOU issues to the VHA Central Office. Action: Dr. Byhardt will contact Thakor Patel, M.D., VHA Director of Oncology Services, requesting a more specific directive be sent from the VHA to Center Directors to insure IRB fees are waived for NCI sponsored trials. Appropriate budgeting at the VHA Headquarters level with pass through to local sites is needed to deal with increasing drug costs as well as the cost of laboratory studies, imaging studies and other protocol related costs, so that the MOU is more than an unfunded mandate. 2) Addressing the issue to the NCI. Action: Dr. Byhardt will contact Andrea Denicoff at NCI, coordinator for the VA/MTF supplemental grant. She may be able to effectively communicate the above issues to VHA and DOD leadership to effectuate the necessary changes. 3) The VA/MTF members feel the per case reimbursement is helpful but does not address the underlying infra structure problems adequately. Most VA/MTF’s would benefit more from support that’s not accrual-based. Accrual can’t be achieved without adequate data management, but the sites cannot receive funds until they begin accrual. The NCI supplement could perhaps be restructured in the renewal grant to be in the form of partial support of data management costs. Perhaps a matching funds approach from the VA/MTF site or affiliated academic center could be adopted for the next grant cycle. An incentive for case accrual could perhaps kick in above an accrual minimum. Action: Dr. Byhardt and Tom Wudarski will conduct a conference call with Dr. Curran to develop a strategy for the grant renewal that meets the above objectives. 4) The possibility of having the VHA and/or DOD consider allowing the use of the CIRB for cooperative group trials was discussed as a means to simplify the IRB issues. Obviously, the local institution would still have to conduct ethical review and oversight, but their work burden could be decreased by permitting scientific review via the CIRB. Action: Dr. Byhardt will discuss the issue with the VA Oncology Field Advisory Committee and Dr. Patel. The committee also discussed a better system for e-mail notification from RTOG to the key VA/MTF’s physicians in order to notify them of availability of reimbursement for meeting travel to RTOG. Dr. Kasimis and Dr. Byhardt will communicate to develop a better e-mail broadcast list. VA/MTF MEETING (January, 2004) Roger W. Byhardt, M.D., Chair Fifteen Veterans Administration (VA) and four Military Treatment Facilities (MTF) representatives attended the meeting. Dr. Byhardt, Committee, Chair called the meeting to order. Tom Wudarski, RTOG Administrator gave a report of the supplemental grant and VA/MTF accrual. The supplemental grant continues along with regular NCI grant until renewal scheduled for 2007. VA/MTF accrual is down from about 200 for 2001 to 129 for 2003. Tom noted that the grant can only be used for case accrual and travel and encouraged the committee to examine possible reasons for decreased accrual. After some discussion the main reasons for the fall off were identified as: 1) A decrease in the number of available protocols for prostate cancer, lung and head and neck cancer, the main cancer types seen at the VA/MTF's. This problem could become more acute next year when RTOG 9910 closes. The replacement trial RTOG 0126 is a dose-escalation study using 3D-CRT that not all VA's will be able to qualify for. 2) Increased complexity of available studies (e.g., RTOG 0126) for these three sites, requiring technology or techniques not available at all the VA/MTF sites (e.g., 3D-CRT, IMRT, prostate localization equipment such as BAT, immobilization devices, etc.). 3) Continued lack of infrastructure support from the VA, such as data management, clerical assistance, etc. 4) Increasing burden of regulatory requirements from VA Research stand down, HIPAA, and, in turn, from local IRB's. The latter includes requests by some IRB's for up-front payment of up to $1,500 to process a new protocol and $500 for annual renewal. Also, some local VA's do not recognize the VHA's portion of the NCI/VA agreement to provide the necessary imaging and other supportive services to facilitate carrying out protocol treatment. Some VA's are still asking for payment of the costs of protocol-mandated imaging ("aid-required") and other tests they consider not within the standard of care. Even with the supplemental payment, the cost of paying for these studies would quickly exhaust and/or outstrip per-case reimbursement, especially when the reimbursement must also cover the cost of data management. The subsequent discussion made the following key points: 1) We need to remind the site committees to design simpler "real world" studies to facilitate broader group participation. In the meantime, the VA/MTF will continue to develop straightforward trials that target our unique population and run these as pilot studies that can be taken to the site committees for larger group-wide study development. 2) VA headquarters and the VA Oncology FAC are trying to compile an inventory of VA Radiation Therapy equipment and determine what equipment replacement time lines are so that a master list of new equipment needs can be compiled to take advantage of bulk ordering discounts through the VA NAC. At the same time, the master list should look toward bringing the capability of the larger facilities up to a standard of care level that will permit them to match that in their communities and to participate in clinical trials. The inventory effort has been stalled by only a 40% response from the queried facilities. There is very little VHA infrastructure support to conduct a proper inventory. It was also noted that the M-9 document written by the VA Oncology FAC, was not signed by VHA HQ and is now dead. It gave equipment and personnel guidelines and would have provided a basis for making the staffing and equipment of all VA in-house RT facilities more uniform. Nevertheless, it is still a document that can be referenced. 3) It was suggested to have RTOG HQ put in a request to NCI to be able to divert some of the supplemental funds towards data management support or to simplify the protocol submission process for VA/MTF's by allowing the use of a central IRB. Judging from the tenor of recent developments in local IRB's, VHA/DOD would have to convince the local IRB's to give up some of their control over the approval process and administratively approve studies approved by the CIRB. 4) The details of the NCI/VA agreement were discussed so that committee members could reference the appropriate documents in dealing with their local IRB's about cost and charge issues. It was again noted that increasing regulatory burden from both the VA and NCI has further stressed the limited research infrastructure within the VA/MTF's to the point where some major VA accruers (20 cases per year) have been forced to cease RTOG activity. Other means to facilitate the infrastructure issue were discussed, including joint center arrangements with full member academic institutions. 5) It was suggested that Dr. Byhardt, as a member of the VA Oncology FAC, take several of the above issues to the FAC as agenda items for their next meeting, namely, the CIRB, the IRB charge issues, and the lack of uniform radiation therapy equipment. 6) It was also suggested that within a month of the time when the new VA Chief of Research and Development is named, a VA/MTF delegation meet with the aim of convincing him to advocate for the changes needed to facilitate VA accrual. The delegation would consist of Tom Wudarski, and Drs. Byhardt, Hagen, Kasimis, and Gardner. This could either be in the form of the delegation going to Washington or inviting the new Chief to come to RTOG HQ where we could meet or to invite him to come to the next meeting and speak to the VA/MTF about his goals. Finally, Dr. Hagan discussed the progress of the VA/MTF prostate pilot study that will examine the cessation of hormone therapy in patients who have been receiving long-term hormone therapy for PSA failure after radiation therapy. It will look at the percentage of patients that achieve permanent castrate level of testosterone even after cessation of long-term hormone therapy. It will also monitor the PSA level. This study is targeted to accrue 50 patients and will be run as an in-house trial at about 10 of the VA/MTF member facilities. The data will be sent to MCV, where Dr. Hagen's data management team will compile and collate the data. The completed data will then be presented to the Genitourinary Cancer Committee as the basis for a larger group-wide study that can look at the issue more comprehensively. It was felt that the best use of our VA/MTF group is to develop simple and straightforward pilots that can form the basis for larger group-wide studies. In this way, the accrual can be increased from VA/MTF's by having available studies that easily target our unique patient population and we can serve as a useful pilot development tool for RTOG. As a final note, Dr. Vijaykumar informed the group that he has just gone to UC Davis and will be working with the Sacramento VA in bringing them on-line for RTOG studies. This association could facilitate further VA/MTF accrual. VA/MTF MEETING (January, 2003) Roger W. Byhardt, M.D., Chair 1. Tom Wudarski spoke to the group about the supplemental grant and noted that the $600 per case supplement will probably continue through the rest of the grant period. He answered some questions about use of the grant money for travel to the meeting, indicating he should be contacted for travel approval to be sure there are enough funds. He noted we have sufficient funds in the grant to cover a larger VA/MTF accrual and encouraged us to develop means to increase accrual. 2. The group then discussed the protocol proposed by Mike Hagan. A Phase II trial of attempted cessation of prolonged duration LHRH therapy in patients with adenocarcinoma of the prostate. He noted that the concept has been approved by the Gastrointestinal Cancer Committee, but needs a source of funding for the statistics section. It was decided that the study would run as a VA/MTF only study and that the VA/MTF group would function conceptually as the "University of VA/MTF" to pilot unique ideas that might later be adaptable to group-wide study in RTOG. Chuck Scott subsequently approved having the protocol sent to him to be assigned to an RTOG statistician. When completed, the trial will be run as an RTOG study but open only to RTOG VA/MTF's. Roger Byhardt will explore the details with Wally Curran and Tom Wudarski of just how the VA/MTF group and RTOG should inter-relate regarding this protocol. 3. The stereotactic radioablation study for lung cancer was briefly discussed and it was decided that the VA/MTF group would participate in the group-wide SRA when it opens and focus its protocol development energy primarily on the prostate study. 4. Roger Byhardt noted that in response to queries made after the last meeting about addressing VA equipment issues with VA HQ, he was put in contact with Dr. Patel at VA HQ and appointed him as a member of the VA Oncology Field Advisory Committee (VAOFAC). They have already met several times to address equipment, space and personnel issues in updating and modified the "M-9 Document", The VA Criteria and Standards for Oncology Programs. New language in this document, which should be approved soon by HQ, will make it easier for VA-based oncology programs to meet their equipment, space, and personnel needs. At the next meeting of the VAOFAC, issues of funding sources for VA-based clinical trials will be discussed. Several VA/MTF members requested a copy of the M-9 document. VA/MTF MEETING (June, 2002) Roger Byhardt, M.D., Chair The VA/MTF meeting was held on 6/15/02 at 10:30 am with seven members in attendance. Tom Wudarski gave a brief presentation on the status of the supplemental grant. Basically, the grant has been renewed and will continue to pay an additional per case reimbursement of $600 for cases accrued from VA/MTF facilities. There was discussion carried over from the last meeting of the stereotactic radiosurgery protocol for small cell lung cancer in medically unresectable patients and the study for evaluating osteoporosis risk in prostate cancer patients on TAS. It was decided that most VA's could not participate in the stereotactic study until VA Central Office provides the necessary hardware. In the meantime the study continues to develop in the full Lung Cancer Committee. Mike Hagan was not able to attend the meeting so further discussion on the prostate study was tabled. Basil Kasimis suggested that VA Central Office be contacted through the Oncology Field Advisory Committee (FAC) regarding purchase of stereotactic body frames and breath control devices for selected VISN-based VA's. Dr. Byhardt is a member of the FAC and will bring the issue to their next meeting in September. It was also suggested that in order to get a higher profile for Radiation Oncology in the VA, that speakers be invited to present information on PET/CT fusion (Jeff Bradley) and on stereotactic radiosurgery (Ron McGarry) at the October VA Oncology Symposium. While it may be too late to get them on as plenary speakers this year, they could submit an abstract for these presentations. VA/MTF MEETING (January, 2002) Roger W. Byhardt, M.D., Chair 1. The meeting was called to order at 10:30 am and 10 participants signed in. 2. Tom Wudarski spoke to the group about the supplemental grant and noted that the $600 per case supplement will continue thru the next year with a good expectation that it will continue thru the grant period. He then addressed a few questions, such as, how to transfer money to an RT department within an MTF and how to deal with an affiliated medical school in crediting the supplement to the VA without the VA research office making a claim on it. 3. The VA/MOG proposal was briefly discussed and it was concluded that the proposal would not be resubmitted until the group can demonstrate its ability to design and initiate a protocol on its own. After that, it was felt that it was best to meet with Dr. Feussner again before submitting anything. 4. Then a discussion was held regarding two protocols that have been proposed. The first was stereotactic radiosurgery for small lung cancers in medically inoperable patients, which the VA has a large number of. It was decided that we cannot participate in this until the RTOG VA have the appropriate equipment for immobilization and dealing with breathing motion. It was decided that a delegation of the VA/MTF committee would meet with Dr. Holohan, in Washington, to discuss means by which the VA could assure this resource was available in each VISN. 5. The second was to submit a proposal to the RTOG Epidemiology Subcommittee to add several new data points on the patient entry forms for RTOG study enrollment that would ask about service in Vietnam, Gulf War, etc., to capture information about exposure to Agent Orange and other toxins that might have a carcinogenic link. Only 10% of all veterans are treated at VA's. The rest receive care at private hospitals since they have private health insurance. Thus, this data needs to be obtained on all RTOG study patients. Doug Martin, of Portsmouth Naval Hospital will put together this proposal and submit it along with Roger Byhardt. 6. The third study presented was a proposal to evaluate the relationship of the duration of TAS and return of normal testosterone function in patients treated with TAS for PSDA failure after RT. The aim would be to minimize the length of time patients would have to remain on TAS. At the first sign of rise in PSA after TAS cessation and testosterone recovery, TAS could be reinstated. This could limit the risk of osteoporosis. The concept was presented by Mike Hagan, who already has a first draft protocol. He has discussed the study with Howard Sandler, Chair of the Genitourinary Cancer Committee, who likes the concept. Mike had plans to present the concept to the Genitourinary Cancer Committee for consideration. If approved there it would go forward as a VA/MTF initiated study. The group decided that accrual could come from VA/MTF's alone and be completed in a reasonable length of time. If accrual is slow, it could be opened for group-wide accrual, but would still be identified as a VA/MTF initiative. 7. Roger Byhardt and Basil Kasimis will make arrangements in the near future to discuss the equipment issue with Dr. Holohan. They will obtain data from NCI regarding the benefits that the VA has derived from involvement in clinical trials through RTOG, as well as the other cooperative groups, which was made possible by the NCI/VA memo of understanding. For example, veterans have had access to investigation agents and approaches that would not have been otherwise available and have received other agents at no cost. This information will be presented to Dr. Holohan to illustrate the advantages of study participation and the need to keep VA cancer treatment resources up to community standards so that such participation can continue.