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 feasibility of treatment in patients with high
risk endometrial cancer treated by vaginal cuff brachytherapy followed by 3 cycles of dose
dense paclitaxel and carboplatin chemotherapy.
Detailed Description
Before the patient begins the study:
Endometrial cancer is commonly treated with surgery. The patient must have already had
surgery including hysterectomy (removal of the uterus) prior to being considered eligible for
this study. The surgery may also include removal of pelvic and para-aortic lymph nodes.
Following the surgery, the doctor will identify if the patient has factors related to the
cancer which places the patient at a greater risk for the cancer returning.
Prior to participating in this study there are exams, tests or procedures to find out if the
patient can be treated in the study. Most are part of regular cancer care.
Treatment:
All patients will receive radiation therapy followed by three cycles of dose dense paclitaxel
and carboplatin chemotherapy. Radiation therapy will be delivered either by LDR or HDR
brachytherapy and must be specified at the time of enrollment. The vaginal brachytherapy
should be started within 12 weeks of surgery (within 2 weeks of enrollment). Chemotherapy
should start within 3 weeks of initiating brachytherapy.
Study participation will be up to two years.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Number of Patients Completing the Protocol
Secondary Outcome
Frequency of Adverse Events Related to Acute Toxicity During Treatment
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
39
Start Date
October 2, 2017
Completion Date
December 13, 2022
Primary Completion Date
December 13, 2019
Eligibility Criteria
Inclusion Criteria:
1. All patients must have undergone hysterectomy. Bilateral salpingooophorectomy is
strongly encouraged but not mandatory.
2. Pelvic and para-aortic lymphadenectomy are optional, but strongly encouraged.
Peritoneal washing are optional.
3. If either a bilateral salpingo-oophorectomy or nodal dissection was not performed,
post-operative pre-treatment CT/MRI is required and must not demonstrate evidence
suggestive of metastatic disease (adnexa, nodes, intraperitoneal disease).
Post-operative, pre-treatment CT/MRI must be performed if a pelvic and para-aortic
nodal dissection was not performed.
4. 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 fitting one of the following high-intermediate risk
factor categories:
- age ≥18 years with 3 risk factors
- Risk factors:
1. Grade 2 or 3 tumor, (+) lymphovascular space invasion, outer ½ myometrial
invasion. Patients with these risk criteria may be enrolled with either
positive or negative cytology.
2. Patients with Stage II endometrial carcinoma (any histology) with cervical
stromal invasion. (occult or gross involvement), with or without
high-intermediate risk factors.
3. Patients with serous or clear cell histology (with or without other
high-intermediate risk factors) are eligible provided the disease is
uterine-confined (with or without cervical stromal invasion or endocervical
glandular involvement).
5. Patients must have GOG performance status 0, 1, or 2.
6. Patients must have adequate bone marrow, renal, hepatic and neurologic function per
protocol.
7. Patients who have met the pre-entry requirements specified in protocol; testing
values/results must meet eligibility criteria specified in protocol.
8. Patients must have signed an approved informed consent and authorization permitting
release of personal health information.
Exclusion Criteria:
1. Patients with recurrent disease.
2. Patients with GOG performance status of 3 or 4.
3. Greater than 12 weeks elapsed from surgery to enrollment.
4. Patients have prior pelvic or abdominal radiation therapy.
5. Known hypersensitivity to any component of study treatment that resulted in drug
discontinuation.
6. Significant intercurrent illness including, but not limited to, unstable angina
pectoris, and cardiac arrhythmia, or psychiatric illness/social situation that would
limit compliance with study requirements
7. Active pregnancy or lactation.
8. Prior malignancy requiring treatment within the last 3 years.
Gender
Female
Ages
18 Years - 99 Years
Accepts Healthy Volunteers
No
Contacts
Kathleen Moore, 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
Kathleen Moore, MD, Principal Investigator, Stephenson Cancer Center
Verification Date
August 2021