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ASTRO 2004 CDRP Annual Symposium Expanding Clinical Trials Participation

This annual symposium explores strategies to increase minority access and enrollment in clinical trials. Topics include cooperative group trials, CDRP program metrics, and the role of various cooperative groups such as RTOG, GOG, ECOG, and NSABP. Specific trials discussed include RTOG 0321 for intermediate-risk prostate cancer and RTOG trials for breast, lung, and head and neck cancers.

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ASTRO 2004 CDRP Annual Symposium Expanding Clinical Trials Participation

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  1. ASTRO 2004CDRP Annual SymposiumExpanding Clinical Trials Participation Daniel G. Petereit, MD Rapid City Regional Hospital Rapid City, SD Bobby Bains, MD Laredo Medical Center Laredo, Tx Michael Steinberg, MD Daniel Freeman Hospital Inglewood, CA

  2. Univ. of Wisconsin, Madison, WI Clinical Center, NIH National Navy Medical Center, Bethesda, MD Daniel Freeman Memorial Hospital, Inglewood, CA Wheeling Hospital, WV New Hanover Regional Medical Center, Wilmington, NC UNC Chapel Hill, Chapel Hill, NC Singing River Hospital, Pascagoula, MS Holy Cross Hospital, Fort Lauderdale, FL CDRP Sites UPMC McKeesport Hospital, McKeesport, PA Rapid City Regional Hospital, Rapid City, SD Univ. Pittsburgh Medical Center, Pittsburgh, PA Children’s National Medical Center, Washington, DC USC, California Univ. Texas Health Science Center, San Antonio, TX Mercy Hospital, Laredo, TX Univ. of Alabama, Tuscaloosa, AL

  3. Expanding Clinical Trials Participation • Increasing minority access and enrollment on clinical trials • Major metric CDRP program • Cooperative group trials • RTOG – partner with CDRP program • Other cooperative group trials • CTSU mechanism • GOG, ECOG,NSABP, etc • CDRP trials • Prostate, breast, lung, H&N

  4. RTOG 0321- HDR Brachytherapy Intermediate-Risk Prostate CancerDaniel Freeman Trial • Intermediate risk patients • 45 Gy EBRT, HDR boost 19 Gy 2 fractions • Primary goal: determine Grade 3 or greater GU and GI toxicities • Secondary goal: FFR, OS, and DFS • N= 110 • Michael Steinberg, MD

  5. HDR Brachytherapy Intermediate-Risk Prostate CancerRapid City Trial • PI: Daniel Petereit, MD Co-PIs: Jack Fowler, PhD, Mark Ritter, MD, PhD, Richard Chappell, PhD • Patient eligibility: intermediate, high-risk prostate cancer • Androgen ablation: 6 to 12 months • EBRT: 2.2 Gy x 16 over 15 treatment days, HDR 6.5 Gy x 3 • Endpoints: • Evaluate the rate acute, late toxicities • Enhance the participation of Native Americans on clinical trials • Influence stage at presentation • Efficacy HDR boost • 50 pts Rapid City • CDRP study: Rapid City, Laredo, others

  6. Rapid City HDR Prostate Study • 81 patients • Low, Intermediate, High: 25%, 40%, 35% • Median F/U: 4 years • 45 Gy WP, 5.5 – 6.5 Gy in 3 to 4 Fx • 5 failures • Overall: 92% bNED • Low, Intermediate, High: 100%, 95%, 85% • Urethral stricture rate: 5 (6%)

  7. RAPID CITY REGIONAL HOSPITAL John T. Vucurevich Cancer Care Institute

  8. Š 50 PTS Š 50 PTS Š 50 PTS 4.3 Phase I/II Tomotherapy Prostate Trial UW /Rapid City Trial Level 1: 50 patients, modest acute toxicities G2 rectal toxicities: 2 Level II: 1 patient

  9. Daniel Freeman Trials Other RTOG Trials • RTOG 0232- Phase III Study comparing combined EBRT and PSI with brachytherapy alone for select intermediate prostatate CA • RTOG 0247- Randomized phase II trial of neoadjuvant combined modality therapy for locally advanced rectal cancer • Michael Steinberg, MD

  10. Daniel Freeman Trials Other Trials • RTOG 9804- Phase III trial of observation+/- tamoxifen vs RT +/- tamoxifen for good risk (DCIS) • RTOG 0214- A Phase III comparison of PCI versus observation in patients with locally advanced non-small cell cancer • Michael Steinberg, MD

  11. Daniel Freeman Trials Other Trials • Mammosite DCIS Trial- To determine the toxicity and local control with Mammosite brachytherapy for DCIS • P4 – Prostate Profile Project To develop a data/tissue/blood/specimen/anatomical part/cell line repository that can be used for studying the biology, etiology, genetics, and pharmacogenetics of prostate cancer and related diseases • Michael Steinberg, MD

  12. Phase II Trial HDR Brachytherapy Stage I and II Breast Carcinoma Rapid City Trial • PI: Daniel Petereit, MD Co-PIs: Scott Tannehill, MD, Jack Fowler, PhD, Richard Chappell, PhD • Western, South Dakota: historically, very low breast conservation rate • Tumors < 3 cm, NO, N1 (1-3 LNs) • 34 Gy/10 Fxs, or 32 Gy/8 Fxs • Endpoints: • Evaluate the rate acute, late toxicities • Enhance the participation of Native Americans on clinical trials • Influence stage at presentation • Efficacy, local control, cosmesis • 50 pts: • DSMB • Parallel study open enrollment • CDRP study

  13. STRATIFY # of positive nodes (0,1-3,>3) Type of chemotherapy (anthracycline, other, or none) Hormonal therapy (yes, no) # of axillary nodes removed (<10 or ≥10) Centre Radiation toBreast, Ipsilateral Axilla, Supraclav and Internal Mammary Lymph nodes CTSU Regional RT Breast TrialLaredo Trials Randomize Radiation only to Breast Bobby Bains, MD

  14. STRATIFY RPA Class (good features vs adverse) Chemotherapy after XRT planned (yes or no) Whole Brain Radiation alone 37.5 Gy in 2.5 Gy fractions over 3 weeks. Phase III Trial WBRT + Thalidomide (RTOG) Laredo Trials Randomize Oral Thalidomide + Whole Brain Radiation 37.5 Gy in 2.5 Gy Fx over 3 weeks Bobby Bains, MD

  15. Ataxia TelangiectasiaUW /Rapid City Trial • ATM mutations in female breast cancer patients may predict for an increase in radiation-induced late effects. • Atencio DP et al. Environmental & Molecular Mutagenesis 38:200-8, 2001 • 46 patients, breast conservation, HPLC ID genetic variants • 9 ATM mutations 6 patients • A significant correlation between ATM mutation status and the development of Grade 3-4 subcutaneous late effects • All 3 of the patients (100%) who manifested Grade 3-4 subcutaneous late sequelae possessed ATM mutations, whereas only 3 (7%) of the 43 patients who did not develop this form of severe toxicity harbored an ATM mutation

  16. ATM MUTATIONS in Native Americans: Possible Association with Cancer and Radiotherapy ToxicitiesUW /Rapid City Trial • Exploratory pilot study to compare the baseline incidence of ATM heterozygosity of Native Americans with cancer, who are undergoing radiation therapy, to a similar group of non-Native Americans. • To determine the association between ATM heterozygosity and sensitivity to radiation. • University of Wisconsin: Mark Ritter, MD,PhD Amy Moser, PhD; Roger Wiseman, PhD

  17. Obtaining Approval Indian Health Service • Dilemma: seeking approval nation, not just an individual • Required process • Resolution from Tribal Health Council • Letter from Service Unit Director • Resolution from Aberdeen Area Tribal Chairmens Health Board • Each requires special meeting and presentation and packet of summary materials • Each protocol • 4 Native American Populations • NINE LETTERS OR RESOLUTIONS • Total: 6 protocols • 54 LETTERS/RESOLUTIONS

  18. Prot 1/1: Prostate Brachy - NAI Prot 1/2: Prostate Brachy RCRH IRB Prot 2/1: Breast Brachy - NAI Prot 2/2: Breast Brachy Prot 3: Community Survey Prot 4: Navigator Prot 5: Tomo Bone Prot 6: Tomo Prostate Prot 1/1: Prostate Brachy - NAI Prot 1/2: Prostate Brachy Prot 2/1: Breast Brachy - NAI UW IRB Prot 2/2: Breast Brachy Prot 5: Tomo Bone Prot 6: Tomo Prostate Submitted Approved withfinal letter Ready to enroll after NCI appr. January 04 February 04 March 04 October 03 June 03 July 03 August 03 September 03 November 03 December 03 April 04 May 04 June 04 July 04 August 04 September 04 Prot 1/1: Prostate Brachy - NAI Prot 2/1: Breast Brachy - NAI AAIRB Prot 3: Community Survey Prot 4: Navigator Prot 5: Tomo Bone Prot 6: Tomo Prostate Prot 1/1: Prostate Brachy - NAI Nat.IRB Prot 2/1: Breast Brachy - NAI Prot 3: Community Survey Prot 4: Navigator Prot 5: Tomo Bone Prot 6: Tomo Prostate Protocol Timeline 2003 - 2004

  19. Goal of Research Grant Through the use of technologically advanced radiation delivery systems, the potential exists that some treatment barriers will be lowered, and therefore, cure rates enhanced.

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