NCT03422198 Short Course Vaginal Cuff Brachytherapy in Treating Participants With Stage I-II Endometrial Cancer
| NCT ID | NCT03422198 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | University of Utah |
| Condition | Endometrial Clear Cell Adenocarcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 188 participants |
| Start Date | 2018-02-02 |
| Primary Completion | 2026-11-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 188 participants in total. It began in 2018-02-02 with a primary completion date of 2026-11-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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-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
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.
Contact & Investigator
Cristina DeCesaris, MD
PRINCIPAL INVESTIGATOR
Huntsman Cancer Institute
Frequently Asked Questions
Who can join the NCT03422198 clinical trial?
This trial is open to participants of all sexes, studying Endometrial Clear Cell Adenocarcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT03422198 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 188 participants.
Is NCT03422198 currently recruiting?
Yes, NCT03422198 is actively recruiting participants. Contact the research team at Rachel.Kingsford@hci.utah.edu for enrollment information.
Where is the NCT03422198 trial being conducted?
This trial is being conducted at Palo Alto, United States, Maywood, United States, Houston, United States, Salt Lake City, United States and 1 additional location.
Who is sponsoring the NCT03422198 clinical trial?
NCT03422198 is sponsored by University of Utah. The principal investigator is Cristina DeCesaris, MD at Huntsman Cancer Institute. The trial plans to enroll 188 participants.