Phase II Trial of Vaginal Cuff Brachytherapy Followed by Carboplatin and Paclitaxel Chemotherapy in Patients With Stage I-IIb Papillary Serous, Clear Cell and Endometrioid Endometrial Cancer With High-Intermediate Risk Factors
All patients must have undergone complete surgical staging including bilateral pelvic and
para-aortic lymphadenectomy. All patients will receive radiation therapy. Treatment will be
delivered either by LDR or HDR brachytherapy. The treatment plan must be started at the time
of enrollment. The vaginal brachytherapy should be started within 4 weeks of surgery
(within 2 weeks of enrollment), in order to avoid delays in initiation of systemic therapy,
which should start on post-operative day 21. The dose will be prescribed to the vaginal
(mucosal) surface as defined at the surface of the applicators. Following vaginal cuff
radiation therapy, all patients will receive chemotherapy.
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine the progression-free survival of patients with surgically staged, Stage I-II papillary serous, clear cell, or endometrioid carcinomas with high-intermediate risk factors treated by vaginal cuff brachytherapy followed by chemotherapy.
Scott McMeekin, MD
University of Oklahoma
United States: Institutional Review Board
Vaginal Cuff Brachy
|University of Oklahoma Health Sciences Center||Oklahoma City, Oklahoma 73104|