NCT03189446

Vaginal Cuff Brachytherapy Followed by Chemotherapy in Endometrial Cancer

Phase II Trial of Vaginal Cuff Brachytherapy Followed by Adjuvant Chemotherapy With Carboplatin and Dose Dense Paclitaxel in Patients With High-Risk Endometrial Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 39 (actual)
• Sponsor: University of Oklahoma · Academic / Other
• Sex: Female
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the feasibility of treatment in patients with high risk endometrial cancer treated by vaginal cuff brachytherapy followed by 3 cycles of dose dense paclitaxel and carboplatin chemotherapy.

Detailed description

Before the patient begins the study: Endometrial cancer is commonly treated with surgery. The patient must have already had surgery including hysterectomy (removal of the uterus) prior to being considered eligible for this study. The surgery may also include removal of pelvic and para-aortic lymph nodes. Following the surgery, the doctor will identify if the patient has factors related to the cancer which places the patient at a greater risk for the cancer returning. Prior to participating in this study there are exams, tests or procedures to find out if the patient can be treated in the study. Most are part of regular cancer care. Treatment: All patients will receive radiation therapy followed by three cycles of dose dense paclitaxel and carboplatin chemotherapy. Radiation therapy will be delivered either by LDR or HDR brachytherapy and must be specified at the time of enrollment. The vaginal brachytherapy should be started within 12 weeks of surgery (within 2 weeks of enrollment). Chemotherapy should start within 3 weeks of initiating brachytherapy. Study participation will be up to two years.

Conditions

• Endometrial Cancer
• Papillary Serous
• Clear Cell Endometrial Cancer

Interventions

Type	Name	Description
RADIATION	Vaginal Cuff Brachytherapy	Within 12 weeks of surgery. Either LDR or HDR brachytherapy will be permitted
DRUG	Carboplatin	Carboplatin IV on day 1 of a 21 day cycle for 3 cycles
DRUG	Paclitaxel	Paclitaxel IV on days 1,8 and 15 of a 21 day cycle for 3 cycles

Timeline

• Start date: 2017-10-02
• Primary completion: 2019-12-13
• Completion: 2021-10-06
• First posted: 2017-06-16
• Last updated: 2024-03-08
• Results posted: 2021-01-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study