Endometrial Committee
David Scott Miller, M.D., F.A.C.O.G., F.A.C.S.
Director and Dallas Foundation Chair in Gynecologic O...
Resected Endometrial
• GOG0249: A Phase III Trial of Pelvic
Radiation Therapy versus Vaginal Cuff
Brachytherapy Followed b...
Resected Endometrial
• PORTEC 3: Randomized Phase III Trial
Comparing Concurrent Chemoradiation
and Adjuvant Chemotherapy ...
Resected Endometrial
• GOG258 (UC0704): A Randomized Phase
III Trial of Cisplatin and Tumor Volume
Directed Irradiation Fo...
Study proposal
Proposed new study exploring if the
combination of RT and CT is superior to
CT:
After 4 - A Phase III inter...
Radical surgery
TAH+BSO±LA
CTx4
Primary endpoint
Overall survival (OS)
CTx2
RT
Randomization
Main inclusion criteria
a. En...
Pelvic Recurrence
• GOG0238: A Randomized Trial of Pelvic
Irradiation with or without Concurrent
Weekly Cisplatin in Patie...
EN.8 - A PHASE III STUDY OF STANDARD
THERAPY VERSUS RIDAFOROLIMUS IN
WOMEN WITH RECURRENT OR METASTATIC
ENDOMETRIAL CANCER...
Schema
Sample size: Approximately 460 patients
Arm 2:
medroxy progesterone 200 mg
or
megestrol 160 mg (as per local
practi...
Carcinosarcoma
GOG0261: Randomized Phase III Trial of
Carboplatin plus Paclitaxel versus
Ifosfamide plus Taxol in Patients...
GTN
• Charge from the Executive
• RFP
• ISSTD
GTD Concepts
• Hydatidiform Mole Registry (Quinn)
• Pulse Act-D vs. 8 day MTX for Low Risk
GTN
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Endometrial Committee General Assembly report - David Miller

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Endometrial Committee General Assembly report - David Miller

  1. 1. 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.
  2. 2. 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
  3. 3. 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
  4. 4. 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
  5. 5. Study proposal 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 NSGO HR 0.51 (95 % CI 0.29-0.91) p=0.02 0.77 0.87 0.000.250.500.751.00 197 187 164 149 118 87random = 1 187 175 153 130 106 75random = 0 Number at risk 0 1 2 3 4 5 analysis time random = 0 random = 1 CSS endometrioid carcinomas POOLED DATA Pooled survival data The combination of RT + CT is better than RT Results of previous studies: Thomas Hogberg, Lund Univ Hosp Oct 2009
  6. 6. Radical surgery TAH+BSO±LA CTx4 Primary endpoint Overall survival (OS) CTx2 RT Randomization 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 N=1000 Proposed study Thomas Hogberg, Lund Univ Hosp Oct 2009
  7. 7. 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
  8. 8. 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,Interested Groups: ACRIN, AGO-AUST, AGO-OVAR, ANZGOG?, DUTCH GOG, EORTC, GEICO, GINECO,ANZGOG?, DUTCH GOG, EORTC, GEICO, GINECO, JGOG, MANGO, MITO, NCRI, NSGO, SWOGJGOG, MANGO, MITO, NCRI, NSGO, SWOG
  9. 9. Schema Sample size: Approximately 460 patients Arm 2: medroxy progesterone 200 mg or megestrol 160 mg (as per local practice) po daily Chemotherapy options Survival follow-up Disease progression Imaging q 8 weeks Arm 1: ridaforolimus 40 mg po days 1-5 each week R A N D O M I Z E Women with recurrent or metastatic endometrial cancer 1-2 Prior Chemotherapy
  10. 10. 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
  11. 11. GTN • Charge from the Executive • RFP • ISSTD
  12. 12. GTD Concepts • Hydatidiform Mole Registry (Quinn) • Pulse Act-D vs. 8 day MTX for Low Risk GTN

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