CI

At a glance

ClinicalIndex Comparison Record
Phase 3Recruiting· 188 target
Drug / intervention
Vaginal Cuff Brachytherapy +1 moreradiation
Likely dose
Not stated in record
Key inclusion· 9
  • Histologically confirmed endometrial carcinoma: endometrioid type, serous, clear cell, carcinosarcoma, or other sarcomas
  • FIGO stage IA grade 1 with LVSI, or grades 2-3
  • FIGO stage IB grades 1-3
  • FIGO stage II grades 1-3
Key exclusion· 3
  • Stages other than those specified (I, II, or IIIA without EBRT)
  • Previous pelvic radiotherapy
  • Concurrent malignancy requiring non-protocol anti-cancer treatment other than surgery

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03422198
NCT03422198Phase 3RecruitingOn TrackUpdated 6mo ago
Long Recruiting

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

University of Utah·interventional·Posted Feb 5, 2018·Updated Dec 12, 2025

In Brief

A Phase 3 clinical trial evaluating Vaginal Cuff Brachytherapy and Short course vaginal cuff brachytherapy for Endometrial Clear Cell Adenocarcinoma and 8 related conditions. Currently recruiting, targeting 188 participants across 5 sites.

Detailed 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.

Study Details

Timeline

Phase 3Recruiting
2018201920202021202220232024202520262027202820292030
First PostedFeb 5, 2018
Enrollment StartFeb 2, 2018
Primary CompletionNov 30, 2026
Study CompletionOct 31, 2029
TodayJul 2, 2026
Enrollment to primary: 8.8 yearsPosted 8.4 years agoPrimary completion in 5 months

Interventions

Vaginal Cuff Brachytherapyradiation

Undergo standard of care vaginal cuff brachytherapy

Short course vaginal cuff brachytherapyradiation

Undergo short course vaginal cuff brachytherapy