Short Course Vaginal Cuff Brachytherapy in Treating Participants With Stage I-II Endometrial Cancer

ConditionsEndometrial Clear Cell Adenocarcinoma Endometrial Endometrioid Adenocarcinoma Endometrial Serous Adenocarcinoma Stage I Uterine Corpus Cancer Stage IA Uterine Corpus Cancer Stage IB Uterine Corpus Cancer Stage II Uterine Corpus Cancer Uterine Corpus Carcinosarcoma Uterine Corpus Sarcoma

Trial statusRecruiting

Trial phasePhase 3

Trial typeInterventional

Biological sexAll

AgeNot listed

SponsorUniversity of Utah

About this trial

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-II endometrial cancer. Short course vaginal cuff brachytherapy, also known as internal radiation therapy, uses (over a shorter period) radioactive material placed directly into or near a tumor in the upper portion of the vagina to kill tumor cells.

After completion of cohort 1 (108 participants), the protocol was expended to add a second cohort of 80 additional participants, and re-opened study recruitment.

Eligibility criteria

Qualifiers

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.

Disqualifiers

Stages of endometrial carcinoma other than described.

Previous pelvic radiotherapy.

Concurrent malignancy requiring non-protocol anti-cancer treatment other than surgery.

Trial design

Treatments tested in this trial

Vaginal Cuff Brachytherapy
Short course vaginal cuff brachytherapy

Treatment groups

188 Participants

are divided into 2 treatment groups

Sponsors and collaborators

University of Utah

Lead sponsor

Huntsman Cancer Institute

Collaborator

Source ClinicalTrials.gov