Endometrial Cancer Commitee Minutes Chicago June 3, 2010
David Miller, Ketta Lorusso
Endometrial Cancer Commitee Agenda Chicago June 3, 2010
PROPOSED GCIG STUDIES FOR REVIEW STAGING
LYTEC LYmphadenectomy Trial in Endometrial Cancer
Treatment Algorithm
Participating Institutions Endorsed by ENGOT 2/2010 • • • • • • • • •
AGO Aust
GROIN
EORTC GCG
ICORG
BGOG
MANGO
GEICO
MITO
HECOG
NCRI
GINECO
NOGGO
NSGO
DGC
JGOG
KGOG
TRSGO
Endometrial Cancer Commitee Agenda Chicago June 3, 2010
PROPOSED GCIG STUDIES FOR REVIEW ADVANCED/RECURRENT NCIC CTG EN8 Randomized Phase III trial on Progestational Hormone Therapy vs Deferolimus in women with recurrent or metastatic endometrial cancer
Schema R A Women with N recurrent or D metastatic O endometrial M cancer I 1-2 Prior Z Chemotherapy E
Arm 1: ridaforolimus 40 mg po days 1-5 each week
Imaging Disease Survival q8 progression follow-up weeks Arm 2: medroxy progesterone 200 mg or megestrol 160 mg (as per local practice) po daily Chemotherapy options Sample size: Approximately 460 patients
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, ANZOG, DGOG, EORTC, GEICO, GINECO, JGOG, MANGO, MITO, NCRI, NSGO, SWOG
Endometrial Cancer Commitee Agenda Chicago June 3, 2010
PROPOSED GCIG STUDIES FOR REVIEW TROPHOBLASTIC NEOPLASIA ANZGOG: 1. CHM with negative HCG 8 weeks post evacuation 2. PHM reaching negative HCG Cross registry analysis or randomized trial of current local policy FU vs discontinuation of FU according to the above findings. End point: comparison of incidence of persistent GTN in either arms. To be presented in Prague
Endometrial Cancer Commitee Agenda Chicago June 3, 2010
PROPOSED GCIG STUDIES FOR REVIEW TROPHOBLASTIC NEOPLASIA GOG UC 1005 A sequential phase II/III randomized trial comparing 3 widely used regimens for the management of low risk Gestational Trophoblastic Neoplasia
A randomized trial comparing three widely used regimens for the management of low risk gestational trophoblastic neoplasia –UC1005 Potential trial arms • 8 day 50mg I.M. MTX with folinic acid rescue • 5 day 125mg/m2 I.V. MTX • Biweekly dactinomycin 1.25mg/m2 I.V All arms • QOL assessment Would a two arm trial 8 day MTX vs Act-D be better?
Endometrial Cancer Commitee Agenda Chicago June 3, 2010
PROPOSED GCIG STUDIES FOR REVIEW TROPHOBLASTIC NEOPLASIA GOG UC 1005 A sequential phase II/III randomized trial comparing 3 widely used regimens for the management of low risk Gestational Trophoblastic Neoplasia (John Tidy:
[email protected]). Interested groups: AGO Aust., JGOG, MITO
Endometrial Cancer Commitee Agenda Chicago June 3, 2010
UPDATE ON ACTIVE STUDIES: 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. 22/164 Interested groups: RTOG, NCRI, SWOG
GOG-0242 A phase II study to determine the response to Second Currettage as Initial Management of persistent, low risk, non metastatic GTN: 28/66
Endometrial Cancer Commitee Agenda Chicago June 3, 2010
UPDATE ON ACTIVE STUDIES: GOG 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: 43/84
GOG-0249 A phase III trial of pelvic RT vs Vaginal Cuff Brachitherapy followed by Paclitaxel-Carboplatin Chemotherapy in patients with high risk, early stage endometrial cancer: 112/562 Intersted group: RTOG
Endometrial Cancer Commitee Agenda Chicago June 3, 2010
UPDATE ON ACTIVE STUDIES: GOG GOG-0258 A randomized phase III trial of Cisplatin and Tumor Directed RT followed by Carboplatin/Paclitaxel vs Carboplatin/Paclitaxel for optimally debulked advanced endometrial cancer: 67/804. Interested group: RTOG
GOG-0261 A randomized phase III trial of Carboplatin-Paclitaxel vs Ifosfamide-Paclitaxel in chemotherapy naive patients with newly diagnosed stage I-IV, persistent or recurrent uterine MMT: 47/424. Interested groups: NCRI, GINECO, JGOG, RTOG
Endometrial Cancer Commitee Agenda Chicago June 3, 2010
UPDATE ON ACTIVE STUDIES: NCIC CTG NCIC CTG IND 192 Ridaforolimus in treating patients with recurrent metastatic and/or locally advanced endometrial cancer: 29/32
NCIC CTG IND 179 Phase I of Temsirolimus, Paclitaxel and Carboplatin; have an expanded cohort in endometrial cancer that will continue: completed
Endometrial Cancer Commitee Agenda Chicago June 3, 2010
UPDATE ON ACTIVE STUDIES: DGOG PORTEC 3 Randomized phase III trail comparing Concurrent Chemoradiation and Adjuvant Chemotherapy with palvic Radiation Alone in High Risk and Advanced Endometrial Carcinoma Participating groups: NCRI MaNGO, ANZGOG, NCIC-CTG. NSGO interestd.
AFTER 4 A phase III intergroup trial of adjuvant therapy in radically operated endometrial cancer patients with high risk for micro-metastatic disease: 4 courses of adjuvant CT followed by RT versus 2 more courses of CT: Nothing to report
