Vaginal Cuff Brachytherapy Followed by Chemotherapy in Endometrial Cancer

Endometrial Cancer Clinical Trial

Official title: 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

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Clear Cell Endometrial Cancer
• Endometrial Cancer
• Endometrial Neoplasms
• Papillary Serous

• NCT number: NCT03189446
• Study type: Interventional
• Source: University of Oklahoma
• Status: Completed
• Phase: Phase 2
• Start date: October 2, 2017
• Completion date: October 6, 2021