Brief Title
Vaginal Cuff Brachytherapy Followed by Chemotherapy in Endometrial Cancer
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
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 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 able to complete 6 cycles of treatment
Secondary Outcome
Number of participants with treatment related adverse events
Condition
Endometrial Cancer
Intervention
Vaginal Cuff Brachytherapy
Study Arms / Comparison Groups
Vaginal Cuff Brachytherapy + Chemotherapy
Description: Vaginal cuff brachytherapy followed by Carboplatin (AUC 6) on day 1and Paclitaxel 80 mg/m2 IV over 1 hour days 1, 8, and 15 X 3 total cycles
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
41
Start Date
October 2, 2017
Completion Date
June 1, 2023
Primary Completion Date
June 1, 2022
Eligibility Criteria
Inclusion Criteria:
- All patients must have undergone hysterectomy. Bilateral salpingooophorectomy is
strongly encouraged but not mandatory. Pelvic and para-aortic lymphadenectomy are
optional, but strongly encouraged. Peritoneal washing are optional. If either a
bilateral salpingo-oophorectomy or nodal dissection was not performed, post-operative
pre-treatment CT/MRI is required. All patients will be staged according to the FIGO
2009 staging system and with endometrial carcinoma (endometrioid types) confined to
the corpus uteri or with endocervical glandular involvement. Patients with Stage II
endometrial carcinoma with cervical stromal invasion. Patients with serous or clear
cell histology (with or without other high-intermediate risk factors) are eligible if
disease is uterine confined. Adequate bone marrow, renal, hepatic and neurologic
function.
Exclusion Criteria:
- Patients with recurrent disease. Greater than 12 weeks elapsed from surgery to
enrollment. Prior pelvic or abdominal radiation therapy. Known hypersensitivity to any
component of study treatment. Active pregnancy or lactation. Treatment for prior
malignancy in the last 3 years.
Gender
Female
Ages
18 Years - 99 Years
Accepts Healthy Volunteers
No
Contacts
Lisa Landrum, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT03189446
Organization ID
7964
Responsible Party
Sponsor
Study Sponsor
University of Oklahoma
Study Sponsor
Lisa Landrum, MD, Principal Investigator, OUHSC
Verification Date
November 2019