Short course vaginal cuff brachytherapy for early-stage endometrial cancer
Short Course Adjuvant Vaginal Cuff Brachytherapy (VCB) in Early Endometrial Cancer Compared to Standard of Care (SAVE)
PHASE3 · University of Utah · NCT03422198
This study is testing if a shorter type of radiation treatment for early-stage endometrial cancer is just as effective as the standard longer treatment, while also looking at how it affects patients' quality of life and other factors.
Quick facts
| Phase | PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 188 (estimated) |
| Sex | All |
| Sponsor | University of Utah (other) |
| Drugs / interventions | radiation |
| Locations | 5 sites (Palo Alto, California and 4 other locations) |
| Trial ID | NCT03422198 on ClinicalTrials.gov |
What this trial studies
This phase III trial evaluates the effectiveness of short course vaginal cuff brachytherapy compared to standard care in treating stage I-II endometrial cancer. Participants are randomized into two groups: one receiving the short course treatment and the other receiving the standard treatment over a longer duration. The study aims to assess health-related quality of life, treatment-related symptoms, cost-effectiveness, and patterns of recurrence. It also evaluates the impact on organs at risk and the total distance traveled for treatment visits.
Who should consider this trial
Good fit: Ideal candidates include individuals with histologically confirmed stage I-II endometrial carcinoma who have undergone a hysterectomy and are free from residual disease.
Not a fit: Patients with stages of endometrial carcinoma other than those specified or those with previous pelvic radiation therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a more efficient and effective treatment option for patients with early-stage endometrial cancer.
How similar studies have performed: Other studies have shown promise with similar brachytherapy approaches, but this specific short course method is being evaluated for its unique benefits.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * Stages of endometrial carcinoma other than described. * Previous pelvic radiotherapy. * Concurrent malignancy requiring non-protocol anti-cancer treatment other than surgery.
Where this trial is running
Palo Alto, California and 4 other locations
- Stanford Cancer Center — Palo Alto, California, United States (COMPLETED)
- Loyola University Medical Center — Maywood, Illinois, United States (RECRUITING)
- MD Anderson — Houston, Texas, United States (RECRUITING)
- Huntsman Cancer Institute/University of Utah — Salt Lake City, Utah, United States (RECRUITING)
- Intermountain Medical Center / LDS Hospital — Salt Lake City, Utah, United States (COMPLETED)
Study contacts
- Principal investigator: Cristina DeCesaris, MD — Huntsman Cancer Institute/ University of Utah
- Study coordinator: Rachel Kingsford
- Email: Rachel.Kingsford@hci.utah.edu
- Phone: 801-585-0115
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
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