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Two GOG projects on endometrial carcinoma

As members of the Gynecologic Oncology Group (GOG) we are involved in two exciting projects

A randomized Phase 3 trial of Cisplatin and tumor-volume-directed irradiation followed by Carboplatin and Paclitaxel versus Carboplatin and Paclitaxel alone, for optimally debulked advanced endometrial carcinoma

Advanced endometrial cancer (Stages III and IVA) comprises a heterogeneous group of patients, whose survival remains generally poor. A combined approach of chemotherapy and radiotherapy may provide better disease control, by preventing both local/pelvic recurrences (radiation), as well as failure at distant sites, as opposed to chemotherapy alone. Such approach has been tested in promising Phase II protocols, but has not been validated in a randomized fashion. 

Objective
To determine if treatment with cisplatin and volume-directed radiation followed by carboplatin and paclitaxel for 4 cycles (experimental arm) reduces the rate of recurrence or death (i.e., increases recurrence-free survival) when compared to chemotherapy consisting of carboplatin and paclitaxel for 6 cycles (control arm).

Method
Eliglble patients will have Stages III-IVA endometrial carcinoma (<2 cm residual disease) or patients with FIGO 2009 Stage I or II serous (UPSC) or clear cell endometrial carcinoma and positive cytology. They will be randomized to either:

  • REGIMEN 1: Cisplatin IV Days 1 and 29 plus Volume-directed radiation therapy followed by Carboplatin plus Paclitaxel for 4 cycles, or
  • REGIMEN 2: Carboplatin plus Paclitaxel for 6 cycles 

Principal Investigator: Dr. Lucy Gilbert profile
Co-Investigators: Dr. L. Souhami, Dr. M. Duclos, Dr. Jaroslav Prchal

A molecular staging study of endometrial carcinoma

Data collected will be used to establish centralized database systems for molecular and clinical correlation. This protocol has been structured to address two of the overall high-impact priorities identified by the Gynecologic Cancer Progress Review Group (GYN PRG):

  1. The first involves the identification of markers of risk, molecular disease classifications, prognostic indicators and new targets for prevention and treatment.
  2. The second recognizes the added value of conducting translational research that may improve the quality of life of gynecologic cancer patients.

Objective
Establish a repository of clinical specimens (tissue, urine and serum) with detailed clinical and epidemiologic data from patients with surgically staged endometrial carcinoma.

Method
Translational research, Molecular and Surgico-Pathological staging study of endometrial carcinoma.

Principal Investigator: Dr. Lucy Gilbert profile
Sub-Investigators: Dr. J. Arseneau, Dr. Jaroslav Prchal

Study Coordinator: Natacha Albarracin 514-934-1934 x 31975

Funding:  Gynecologic Oncology Group (GOG) website