Overview

This trial is active, not recruiting.

Conditions endometrial cancer, papillary serous, clear cell endometrial cancer
Treatment vaginal cuff brachytherapy
Phase phase 2
Sponsor University of Oklahoma
Start date September 2007
End date December 2015
Trial size 25 participants
Trial identifier NCT00542490, 1524

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
vaginal cuff brachytherapy
Clinical stage I-II endometrial cancer surgically staged. Stage I-II with any high-intermediate risk (H-IR) features OR Stage IIb any histology OR Stage I-II Papillary Serous or Clear Cell Histology Vaginal cuff brachytherapy Followed by Paclitaxel (175 mg/m2 over 3 hours) and carboplatin (AUC 6) Chemotherapy X 3 (high risk)

Primary Outcomes

Measure
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.
time frame: 2 years

Secondary Outcomes

Measure
To determine the toxicity of vaginal cuff brachytherapy followed by carboplatin and paclitaxel chemotherapy.
time frame: 2 years

Eligibility Criteria

Female participants at least 18 years old.

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.

Additional Information

Official title 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
Principal investigator Scott McMeekin, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2015.
Information provided to ClinicalTrials.gov by University of Oklahoma.