Objectives: This phase III postoperative trial compares a standard regimen of conventional or intensity-modulated pelvic radiotherapy, with an experimental regimen of high-dose or low-dose vaginal cuff brachytherapy followed by up to three cycles of intravenous paclitaxel and carboplatin chemotherapy. Investigators hope not only to improve recurrence-free survival, but also to reduce severe side effects that can impair quality of life.
Key entry or exclusion criteria: Patients must have undergone hysterectomy and bilateral salpingo-oophorectomy with or without pelvic and para-aortic lymphadenectomy within the past 4-12 weeks.
Locations: 412 sites.
Goal: 562 patients.
Study sponsor: Gynecologic Oncology Group in collaboration with the National Cancer Institute.
Link for more information: clinicaltrials.gov/ct2/show/NCT00807768
NIH clinical trials identifier: NCT00807768