Vaginal Cuff Brachytherapy Followed by Chemotherapy in Patients With Endometrioid Cancer
Status and phase
Conditions
Treatments
Details and patient eligibility
About
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.
Full 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.
Enrollment
Sex
Ages
Volunteers
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.
Trial design
Primary purpose
Allocation
Interventional model
Masking
23 participants in 1 patient group
Trial contacts and locations
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal