3- vs 4-fraction high-dose-rate brachytherapy for cervical cancer
Official title: Brachytherapy Fractionation Individualized by Treatment Feasibility in Cervical Cancer: Phase II Trial Comparison of 3 vs 4 Fractions (BRACHY-FIT).
Run by Stanford University · NCT07022470 · Data updated 2026-11-12
This will test whether a three-fraction high-dose-rate brachytherapy schedule works as well as the standard four-fraction schedule for adults with locally advanced cervical cancer.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 41 (estimated) |
| Sponsor | Stanford University Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Palo Alto, California) |
| Status | Recruiting |
| Started | June 3, 2025 |
| Main results expected | June 2028 |
| Study ends | June 2028 |
| Registry record updated | June 12, 2026 |
| Trial ID | NCT07022470 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (age ≥18) with histologically confirmed cervical cancer planned for definitive brachytherapy, ECOG performance status 0-2, who can undergo MRI and provide informed consent are the ideal candidates.
✕Probably not a fit
Patients with prior recent pelvic radiation, contraindications to radiotherapy or MRI, or those who are pregnant or breastfeeding may not be eligible or likely to benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective, non-randomized Phase II single-center trial at Stanford comparing a 3-fraction HDR brachytherapy regimen to the standard 4-fraction regimen in patients receiving definitive treatment for locally advanced cervical cancer. Eligible adults (ECOG 0-2) with histologically confirmed cervical cancer who can undergo MRI and consent are enrolled. Participants receive either three or four HDR brachytherapy fractions as part of their definitive radiotherapy, with close monitoring of treatment delivery and early toxicity. The trial focuses on feasibility and safety of the shorter regimen with follow-up for treatment-related adverse events.
Why it matters
Potential benefit: If successful, the 3-fraction schedule could reduce the number of invasive procedures and clinic visits while maintaining similar cancer control and safety.
How similar studies have gone: Shorter HDR brachytherapy schedules have been reported in single-center and retrospective series with promising toxicity and control rates, but randomized data directly comparing 3 versus 4 fractions are limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Histologically documented malignancy of the cervix and planned to receive brachytherapy as part of definitive treatment. * ECOG performance status of 0-2 * Age ≥ 18 years old. * Ability to understand and the willingness to provide written informed consent. Exclusion Criteria: * Contraindication to receiving radiotherapy as determined by treating radiation oncologist. * Contraindication to receiving MRI. * Prior radiation to the pelvis \> 3 months ago * Age \< 18 years old. * Pregnant or breast-feeding
Where it's running
-
Stanford University
Palo Alto, California, United States Recruiting
Study contacts
- Principal investigator: Elizabeth Kidd, MD — Stanford University
- Study coordinator: Alyssa Yauger
- Email: ayauger@stanford.edu
- Phone: (650) 498-5271
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.