Vaginal Cuff Brachytherapy Followed by Chemotherapy in Endometrial Cancer



Status:Recruiting
Conditions:Cervical Cancer, Cancer, Endometrial Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - 99
Updated:11/2/2017
Start Date:October 2, 2017
End Date:June 1, 2023
Contact:Ingrid Block
Email:ingrid-block@ouhsc.edu
Phone:405 271-8777

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Phase II Trial of Vaginal Cuff Brachytherapy Followed by Adjuvant Chemotherapy With Carboplatin and Dose Dense Paclitaxel in Patients With High-Risk Endometrial Cancer

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.

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.

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.
We found this trial at
1
site
Oklahoma City, Oklahoma 73104
Phone: 405-271-8777
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mi
from
Oklahoma City, OK
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