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Gynecologic Oncology Group Uterine Corpus Trials: GCIG

Gynecologic Oncology Group Uterine Corpus Trials: GCIG . David Scott Miller, M.D., F.A.C.O.G., F.A.C.S. Director and Dallas Foundation Chair in Gynecologic Oncology Professor of Obstetrics & Gynecology University of Texas Southwestern Medical Center Dallas, Texas, U.S.A.

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Gynecologic Oncology Group Uterine Corpus Trials: GCIG

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  1. Gynecologic Oncology GroupUterine Corpus Trials: GCIG David Scott Miller, M.D., F.A.C.O.G., F.A.C.S. Director and Dallas Foundation Chair in Gynecologic Oncology Professor of Obstetrics & Gynecology University of Texas Southwestern Medical Center Dallas, Texas, U.S.A.

  2. PHASE III TRIAL OF PELVIC RADIATION THERAPY VERSUS VAGINAL CUFF BRACHYTHERAPY FOLLOWED BY PACLITAXEL/CARBOPLATIN CHEMOTHERAPY IN PATIENTS WITH HIGH RISK, EARLY STAGE ENDOMETRIAL CANCER

  3. GOG0249 • Objectives • Recurrence free survival • Survival • Patterns of failure • QOL • Stats • 49% decrease in recurrence/death • 85% > 92% 3 yr RFS • N = 562 • Activated 23 Mar 2009

  4. Uterine Corpus Committee0184R • GOG0258 (UC0704): A Randomized Phase III Trial of Cisplatin and Tumor Volume Directed Irradiation Followed by Carboplatin and Paclitaxel vs. Carboplatin and Paclitaxel for Optimally Debulked, Advanced Endometrial Carcinoma

  5. GOG258

  6. GOG0258 • Objectives • Recurrence free survival • Survival • Adverse effects • Stats • 28% decrease recurrence/death • 61% > 70% 3 yr RFS • N = 804

  7. Uterine Corpus Committee Pelvic Recurrence • 33 + 99 has resulted in: • TAH-BSO lymphadenectomy alone • fewer using adjuvant WPRT • GOG0238: A Randomized Trial of Pelvic Irradiation With or Without Concurrent Weekly Cisplatin in Patients With Pelvic-Only Recurrence of Carcinoma of the Uterine Corpus

  8. GOG0238

  9. GOG0238 • Objectives • PFS • Sites of recurrence • OS • Stats • Phase II-III • Interim analysis > 60 failures • Opened Feb ‘08 • N = 164

  10. Uterine Corpus Committee150R & 161R • GOG0261 (UC0701): Randomized Phase III Trial of Carboplatin plus Paclitaxel versus Ifosfamide plus Taxol in Patients with Advanced, Persistent or Recurrent Carcinosarcoma

  11. GOG0261

  12. Objectives OS PFS Toxicity QOL Stats Noninferiority Death rate < 11% N = 415, (264 deaths) GOG261

  13. Concept Biweekly dactinomycin now needs to be tested against 8-day MTX/FAR, arguably the most commonly used regimen worldwide. The 8-day regimen has a similar primary response but a vastly different cost, resource and utility profile, and it has never been subjected to the scrutiny of a multi-centred RCT.

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