RecruitingPhase 3NCT03422198

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

Short Course Adjuvant Vaginal Cuff Brachytherapy (VCB) in Early Endometrial Cancer Compared to Standard of Care (SAVE)

Sponsor

University of Utah

Enrollment

188 participants

Start Date

Feb 2, 2018

Study Type

INTERVENTIONAL

Conditions

Endometrial 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

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-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

Inclusion Criteria9

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 Criteria3

Stages of endometrial carcinoma other than described.
Previous pelvic radiotherapy.
Concurrent malignancy requiring non-protocol anti-cancer treatment other than surgery.