Brief Title
Vaginal Cuff Brachytherapy Followed by Chemotherapy in Patients With Endometrioid Cancer
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
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 Phase
Phase 2
Study Type
Interventional
Primary Outcome
Number of Patients With Progression-free Survival at 2 Years
Secondary Outcome
Number of Patients With at Least One Toxicity Related to Vaginal Cuff Brachytherapy Followed by Carboplatin and Paclitaxel Chemotherapy
Condition
Endometrial Cancer
Intervention
Vaginal Cuff Brachytherapy
Study Arms / Comparison Groups
Vaginal Cuff Brachytherapy
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Radiation
Estimated Enrollment
23
Start Date
September 2007
Completion Date
February 2016
Primary Completion Date
February 2016
Eligibility Criteria
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.
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Scott McMeekin, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT00542490
Organization ID
1524
Responsible Party
Sponsor
Study Sponsor
University of Oklahoma
Study Sponsor
Scott McMeekin, MD, Principal Investigator, University of Oklahoma
Verification Date
August 2020