PORTEC-2, Postoperative Radiation Therapy for Endometrial Carcinoma - A Multicenter Randomised Phase III Trial Comparing External Beam Radiation and Vaginal Brachytherapy
- Compare the rate of 5-year locoregional relapse in patients undergoing external-beam
radiotherapy or vaginal brachytherapy vs observation only after surgery for stage I
- Compare 5-year rate of distant metastases in these patients.
- Determine overall survival rate in these patients.
- Determine prognostic factors for relapse and morbidity.
OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2
- Arm I: Patients undergo either vaginal brachytherapy or external-beam radiotherapy.
- Arm II: Patients are observed and undergo no further treatment. After completion of
study treatment, patients are followed for approximately 83 days.
PROJECTED ACCRUAL: A total of 104 patients will be accrued for this study.
Allocation: Randomized, Primary Purpose: Treatment
Rate of locoregional relapse at 5 years
Carien C. L. Creutzberg, MD, PhD
Leiden University Medical Center
United States: Federal Government