Status:
RECRUITING
Short Course Vaginal Cuff Brachytherapy in Treating Participants With Stage I-II Endometrial Cancer
Lead Sponsor:
University of Utah
Collaborating Sponsors:
Huntsman Cancer Institute
Conditions:
Endometrial Clear Cell Adenocarcinoma
Endometrial Endometrioid Adenocarcinoma
Eligibility:
All Genders
Phase:
PHASE3
Brief Summary
This randomized phase III trial studies short course vaginal cuff brachytherapy to see how well it works compared with standard of care vaginal cuff brachytherapy in treating participants with stage I...
Detailed Description
Endometrial cancer is the most common gynecologic cancer in the Western world and primarily affects postmenopausal women. The primary form of treatment is surgery, consisting of a total abdominal or l...
Eligibility Criteria
Inclusion
- Histologically confirmed endometrial carcinoma: endometrioid type, serous, and clear cell, to include tumors originating in the cervix, but are primarily located in the uterus, and for whom vaginal cuff brachytherapy is indicated. Carcinosarcoma and other sarcomas are permitted; Federation of Gynecology and Obstetrics (FIGO) stage I and stage II, with one of the following combinations of stage and grade:
- Stage IA, grade 1 with LVSI, 2, 3
- Stage IB, grades 1-3
- Stage II, grades 1-3
- Stage IIIA, grades 1-3, not receiving EBRT as part of adjuvant therapy.
- Participants post-hysterectomy and free from residual disease.
- World Health Organization (WHO)/Eastern Cooperative Oncology Group (ECOG)-performance status 0-2.
- Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines.
- Life expectancy of \>2 years.
Exclusion
- Stages of endometrial carcinoma other than described.
- Previous pelvic radiotherapy.
- Concurrent malignancy requiring non-protocol anti-cancer treatment other than surgery.
Key Trial Info
Start Date :
February 2 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 31 2029
Estimated Enrollment :
188 Patients enrolled
Trial Details
Trial ID
NCT03422198
Start Date
February 2 2018
End Date
October 31 2029
Last Update
December 12 2025
Active Locations (5)
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1
Stanford Cancer Center
Palo Alto, California, United States, 94304
2
Loyola University Medical Center
Maywood, Illinois, United States, 60153
3
MD Anderson
Houston, Texas, United States, 77030
4
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, United States, 84112