Vaginal Cuff Brachytherapy Followed by Chemotherapy in Patients With Endometrioid Cancer

Phase 2

Completed

• Conditions: Papillary Serous; Clear Cell Endometrial Cancer; Endometrial Cancer
• Interventions: Radiation: Vaginal Cuff Brachytherapy

• Registration Number: NCT00542490
• Lead Sponsor: University of Oklahoma

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 Timeline

• Study Start: 2007-09
• Study First Submitted: 2007-10-10
• Study First Submitted QC: 2007-10-10
• Study First Posted: 2007-10-11
• Primary Completion: 2016-02
• Study Completion: 2016-02
• Results First Submitted: 2017-04-14
• Results First Submitted QC: 2017-09-25
• Results First Posted: 2017-09-27
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-07
• Last Update Posted: 2020-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 23

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.

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Exclusion Criteria

• Patients with recurrent disease.
• Patients with GOG performance status of 3 or 4.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Vaginal Cuff Brachytherapy	Vaginal Cuff Brachytherapy	-

Primary Outcome Measures

Name	Time	Method
Number of Patients With Progression-free Survival at 2 Years	2 years

Secondary Outcome Measures

Name	Time	Method
Number of Patients With at Least One Toxicity Related to Vaginal Cuff Brachytherapy Followed by Carboplatin and Paclitaxel Chemotherapy	2 years

Trial Locations

Locations (1)

University of Oklahoma Health Sciences Center; 🇺🇸 Oklahoma City, Oklahoma, United States