ENDOMETRIAL CANCER COMMITTEE AGENDA Gynecologic Cancer Intergroup (GCIG) GCIG Autumn 2010 3:30 p.m. – 4:30 p.m., October 21, 2010 Corinthia Hotel, Prague Tiber-Seine-Rhine Room Chairs: David Miller & Ketta Lorusso PROPOSED GCIG STUDIES FOR REVIEW: Staging LYTEC/NESTEC: LYmphadenectomy Trial in Endometrial Cancer Advanced/recurrent: GOG: GOG-0238: 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 participating. NCRI & SWOG interested. NCIC CTG EN 8: Randomized Phase III Study of progestational hormone therapy versus deforolimus in women with recurrent or metastatic endometrial cancer – Interested groups: ACRIN, AGO-AUST, AGO-OVAR, ANZOG, EORTC, GEICO, GINECO, JGOG, MANGO, MITO, NCRI, NSGO, SWOG Trophoblastic neoplasia: ANZGOG: 1.CHM with neg HCG 8 weeks post evacuation 2.PHM reaching neg HCG 1 The diagnosis of molar pregnancy has a major impact on women’s lives. Not only is pregnancy loss a major issue but the need for often prolonged follow up and resultant delay in fertility compounds the situation. An analysis of the Hydatidiform Mole Registry 1,2 results in Melbourne, Australia has revealed no case of persistent trophoblast disease if the HCG is normalised by 8 weeks in Complete Moles and once it is normal in Partial Moles. Validation of the safety of these observations could be.undertaken by cross registry analysis or alternatively by a randomised trial in which patients are randomised to current local policy or to discontinuation of follow up according to the above findings. The end points would be a comparison of the incidence of persistent GTN in either arm. 1. Kerkmeiier L, Wiesma S, Bekkers R, Pyman J, Tan J, Quinn M (2006) Guidelines following hydatidiform mole: a reappraisal. Aust NZ J Obstet Gynaecol 46(2):112-118. 2. Wiesma S, Kerkmeiier, Bekkers R, Tan J, Pyman J and Quinn M (2006) Persistent Trophoblast Disease following Partial Molar Pregnancy Aust NZ J Obstet Gynaecol 46 119-123 GOG: UC1005: A sequential phase II/III randomized trial comparing three widely used regimens for the management of low risk gestational trophoblastic neoplasia UPDATE ON ACTIVE STUDIES: AGO: AGO-GYN 5: Antitumoral Activity and Safety of AEZS-108 in Women with LHRH Receptor Positive Gynecological Tumors DGOG: PORTEC-3: Randomized Phase III Trial Comparing Concurrent Chemoradiation and Adjuvant Chemotherapy with Pelvic Radiation Alone in High Risk and Advanced Stage Endometrial Carcinoma – Participating groups: MaNGO, ANZGOG, NCRI, and NCICCTG. NSGO interested. GOG: 2 GOG-0242: A Phase II Study to Determine the Response to Second Curettage as Initial Management for Persistent Low Risk, Non-Metastatic Gestational Trophoblastic Neoplasia GOG-0248: A Randomized Phase II Trial of Temsirolimus or the Combination of Hormonal Therapy Plus Temsirolimus in Women with Advanced or Recurrent Endometrial Carcinoma GOG-0249: 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 – RTOG would like to participate GOG-0258: 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 – RTOG would like to participate GOG-0261: A Randomized Phase III trial of Carboplatin plus Paclitaxel VERSUS Ifosfamide plus Paclitaxel in Chemotherapy Naïve Patients with Newly Diagnosed Stage I-IV, Persistent or Recurrent Carcinosarcoma (Mixed Mesodermal Tumors) of the Uterus – Interested groups: NCRI, GINECO, JGOG, RTOG NCIC CTG NCIC CTG IND192: Ridaforolimus in Treating Patients with Recurrent Metastatic and/or Locally Advanced Endometrial Cancer NCIC CTG IND ###: Completing phase I of temsirolimus, taxol, and carboplatin; have an expanded cohort in endometrial cancer that will continue; NCIC CTG EN 8: Randomized Phase III Study of progestational hormone therapy versus deforolimus in women with recurrent or metastatic endometrial cancer After 4: A Phase III intergroup trial on adjuvant therapy in radically operated endometrial cancer patients with high risk for micro-metastatic disease: 4 courses of adjuvant CT (CT) followed by radiation therapy (RT) versus 2 more courses of CT 3