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Cancer Disparities Research Partnership (CDRP) Clinical Trials

Cancer Disparities Research Partnership (CDRP) Clinical Trials. Patrick D. Maguire, MD New Hanover Regional Medical Center Wilmington, NC. CDRP “Eastern” Sites. Radiation Oncology Community Outreach Group (ROCOG). Dwight E. Heron, M.D. UPMC-McKeesport & Western PA Consortium

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Cancer Disparities Research Partnership (CDRP) Clinical Trials

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  1. Cancer Disparities Research Partnership (CDRP) Clinical Trials Patrick D. Maguire, MD New Hanover Regional Medical Center Wilmington, NC

  2. CDRP “Eastern” Sites

  3. Radiation Oncology Community Outreach Group (ROCOG) Dwight E. Heron, M.D. UPMC-McKeesport & Western PA Consortium Pittsburgh, PA

  4. ROCOG sites • 5 Hospital, 3 Health Systems • UPMC McKeesport, McKeesport, PA (lead) • Jameson Hospital, New Castle, PA • Somerset Cancer Center, Somerset, PA • UPMC Murtha Cancer Center, Johnstown, PA • Mercy Cancer Center, Pittsburgh, PA • National Mentors • Roswell Park, Buffalo, NY • Washington University, St. Louis, MO

  5. Clinical Trials: ROCOG Breast • Partial breast irradiation (investigator initiated) • Breast brachytherapy • External beam partial breast (3D CRT±IMRT) • Eligible patients • T1 & T2, N1 (no ECE) invasive breast cancer • Uni-focal disease • Negative margins • Study Objective • Acute toxicity • Cosmesis • Late toxicity • Plan to roll into NSABP/RTOG partial breast irradiation when open in Winter 2004

  6. Clinical Trials: ROCOG Prostate • Hypofractionated RT with IMRT • Phase I dose escalation • Eligible patients: • Clinically localized adenocarcinoma of the prostate • T1c-T3b, Gleason score 5-9; PSA ≤20. • Neoadjuvant hormones for 2 months prior to XRT • Treatment with IMRT • Hypofractionation using 2.95 Gy/fraction to 59 Gy in 20 fractions; other fractionation schemes to follow • Study objectives: • Acute and chronic toxicity of hypofractionated IMRT • Efficacy of hypofractionated RT for prostate

  7. Clinical Trials: ROCOG Lung • CDRP Partnership with Dr. Raymond Wynn--Lung Amifostine • Eligible patients • Investigator initiated Phase II • Medically inoperable Stage II, IIIA, IIIB • Study objective: • Incidence of treatment breaks • Acute & Chronic esophagitis, pneumonitis • Impact of RT on pulmonary function (FEV1 & DLCO) • Planned enrollment of at least 10 patients

  8. Other Protocols under consideration • Samarium-153 for osseous carcinomatosis • Investigator-initiated • Conformal RT for pancreatic cancer • ECOG sponsored • Dose escalation for prostate cancer • RTOG

  9. Improving Cancer Outcomes for African-Americans in Southeastern NC Patrick D. Maguire, MD New Hanover Regional Medical Center Wilmington, NC

  10. New Hanover Regional Medical Center (NHRMC) PI: Maguire Co-PIs: Hamann & Kotwall UNC-Wilmington UNC-Chapel Hill Mentor: Tepper Co-Mentors: Rosenman & Morris North Carolina’s CDRP Team

  11. Local Research Team

  12. NHRMC • Largest health care provider in Southeastern NC (New Hanover Health Network) • Nine county service area, mostly rural • Public, county-owned, JCAHO ‘87 • 769 beds; tertiary, teaching hospital • Surgery, Ob/Gyn, IM, & Family Med Residencies

  13. Pilot #1: CMT for Advanced SCC of Head & Neck (SCCHN)

  14. “Toxic Cure” Results (N=50) • 2-year Survival 80% • 2-year PFS 75% • G3 Mucosal Toxicity 100% • Pharynx Stricture 15%

  15. Phase II Trial of Hyperfractionated IMRT with Concurrent Weekly Cisplatin for Stage III and IVa SCCHN Investigator Initiated (NHRMC) Trial Zimmer Cancer Center (ZCC) 0204 PI: Patrick Maguire, MD

  16. ZCC 0204 • Eligibility: III & IVa, excluding N2c & N3 • Regimen: • 70 Gy at 1.25 Gy bid to GTV • CDDP at 33 mg/m2/wk • Planned break after 40 Gy • Endpoints: • Primary = QOL; Secondary = Survival, PFS

  17. Expectations for ZCC 0204 Trial • 10-15 patients per year • 30% African Americans & low income • QOL: prospective swallowing… • Collaboration with UNC-CH for IMRT expertise: TELESYNERGY!!!

  18. Pilot #2: CMT for Stage III Non-Small Cell Lung Cancer (NSCLC)

  19. Induction Chemotherapy Using Paclitaxel, Carboplatin, and CPT-11 with Pegfilgrastim Support Followed by Conformal Radiotherapy and Paclitaxel/Carboplatin/ZD1839 in Unresectable Stage IIIa/b NSCLC Mentor Institution (UNC) Trial Lineberger Comp Cancer Center (LCCC) 0215 PI: David Morris, MD

  20. LCCC 0215 • Patients: • Stage IIIa/b, unresectable • Expect 30% African American • Treatment: • RT - 74Gy qd • Chemo – induction & concurrent • Radiosensitizer - ZD1839 (Iressa)

  21. Cooperative Group Priority Trials for CDRP • BREAST (CALGB 49801): • Tam +/- RT for “Good Risk” DCIS • ANUS (RTOG 9811): • RT/5FU + MMC vs. CDDP • PROSTATE (RTOG 0232): • Brachy +/- EBRT for Intermediate Risk • LUNG PCI (RTOG 0214 & 0212): • NSCLC (phase III) & SCLC (3 fx schemes)

  22. Mississippi-Alabama Radiation Oncology Research Project Raymond Wynn, M.D. Singing River Hospital Pascagoula, MS

  23. Mississippi-Alabama Radiation Oncology Research Project Sharon Spencer, MD John Russell, MD Univ. Alabama CCC Gulf Coast MBCCOP Birmingham, AL Mobile, AL

  24. Pilot #1: IMRT for Head & Neck Cancer Drs. Sharon Spencer, Judith Meredith, & Raymond Wynn

  25. Pilot #2: Phase II Trial of Gamma Knife Radiosurgery & Temozolomide for Newly Diagnosed Brain Metastases Drs. Raymond Wynn, Sharon Spencer, & Joaquin Sariego

  26. RTOG Affiliation • Approved through UAB • Final group approval pending • Nine (9) RTOG protocols IRB-approved • Xerostomia/Mucositis trial under review

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