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Endometrial Committee. 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. Resected Endometrial.
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Endometrial Committee 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.
Resected Endometrial • GOG0249: A 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 (23 Mar 2009) • RTOG
Resected Endometrial • PORTEC 3: Randomized Phase III Trial Comparing Concurrent Chemoradiation and Adjuvant Chemotherapy with Pelvic Radiation Alone in High Risk and Advanced Stage Endometrial Carcinoma • MaNGO, ANZGOG, NRCI, NCIC-CTG, NSGO
Resected Endometrial • GOG258 (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 Cancer (29 Jun 2009) • RTOG
Results of previous studies: Study proposal Pooled survival data NSGO The combination of RT + CT is better than RT Proposed new study exploring if the combination of RT and CT is superior to CT: After 4 - A Phase III intergroup trial on adjuvant therapy in radically operated endometrial cancer patients (FIGO stage IC-IIIC) with high risk for micrometastatic disease Thomas Hogberg, Lund Univ Hosp Oct 2009
Proposed study RT Randomization N=1000 Radical surgery TAH+BSO±LA CTx4 CTx2 Main inclusion criteria a. Endometrioid carcinoma b. Stage 1C grade 3 c. Stage IIA grade 3 and MI≥50%, IIB d. Stage IIIA-C Radical surgery, LA recommended but optional Main exclusion criteria Serous or clear cell carcinoma IIIA with only pos fluid cytology CT :Paclitaxel 175 mg/m2, carboplatin AUC 5-6 (calculated) q 3 weeks Primary endpoint Overall survival (OS) Thomas Hogberg, Lund Univ Hosp Oct 2009
Pelvic Recurrence • 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 • RTOG, NCRI, SWOG
EN.8 - A PHASE III STUDY OF STANDARD THERAPY VERSUS RIDAFOROLIMUS IN WOMEN WITH RECURRENT OR METASTATIC ENDOMETRIAL CANCER WHO HAVE PREVIOUS HAD CHEMOTHERAPY Interested Groups: ACRIN, AGO-AUST, AGO-OVAR, ANZGOG?, DUTCH GOG, EORTC, GEICO, GINECO, JGOG, MANGO, MITO, NCRI, NSGO, SWOG
Schema R A N D O M I Z E Women with recurrent or metastatic endometrial cancer 1-2 Prior Chemotherapy Arm 1: ridaforolimus 40 mg po days 1-5 each week Imaging q 8 weeks Disease progression Survival follow-up Arm 2: medroxy progesterone 200 mg or megestrol 160 mg (as per local practice) po daily Chemotherapy options Sample size: Approximately 460 patients
Carcinosarcoma GOG0261: Randomized Phase III Trial of Carboplatin plus Paclitaxel versus Ifosfamide plus Taxol in Patients with Advanced, Persistent or Recurrent Carcinosarcoma NCRI, GINECO, JGOG, RTOG
GTN • Charge from the Executive • RFP • ISSTD
GTD Concepts • Hydatidiform Mole Registry (Quinn) • Pulse Act-D vs. 8 day MTX for Low Risk GTN