Vaginal Cuff Brachytherapy Followed by Chemotherapy in Patients With Endometrioid Cancer
This trial has been completed.
|Conditions||endometrial cancer, papillary serous, clear cell endometrial cancer|
|Treatment||vaginal cuff brachytherapy|
|Sponsor||University of Oklahoma|
|Start date||September 2007|
|End date||February 2016|
|Trial size||25 participants|
|Trial identifier||NCT00542490, 1524|
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.
|Intervention model||single group assignment|
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
To determine the toxicity of vaginal cuff brachytherapy followed by carboplatin and paclitaxel chemotherapy.
time frame: 2 years
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.
|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.|
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