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
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- University of Oklahoma
- Enrollment
- 23
- Locations
- 2
- Primary Endpoint
- Number of Patients With Progression-free Survival at 2 Years
Study Overview
Brief Summary
The purpose of this study is 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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •All patients must have undergone specified complete surgical staging.
- •Patients must be surgically staged endometrial cancer patients at high-risk for recurrence.
- •Patients must have adequate bone marrow, renal and hepatic function.
Exclusion Criteria
- •Patients with recurrent disease.
- •Patients with GOG performance status of 3 or 4.
Outcomes
Primary Outcomes
Number of Patients With Progression-free Survival at 2 Years
Time Frame: 2 years
Secondary Outcomes
- Number of Patients With at Least One Toxicity Related to Vaginal Cuff Brachytherapy Followed by Carboplatin and Paclitaxel Chemotherapy(2 years)