Vaginal Cuff Brachytherapy Followed by Chemotherapy in Patients With Endometrioid Cancer
| Status: | Completed |
|---|---|
| Conditions: | Cervical Cancer, Cancer, Endometrial Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 9/29/2017 |
| Start Date: | September 2007 |
| End Date: | February 2016 |
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
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.
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.
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.
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.
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.
We found this trial at
1
site
940 NE 13th St
Oklahoma City, Oklahoma 73190
Oklahoma City, Oklahoma 73190
(405) 271-6458
University of Oklahoma Health Sciences Center The OU Health Sciences Center is composed of seven...
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