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
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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: john.tidy@sth.nhs.uk). 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