Actively Recruiting
Brachytherapy Fractionation Individualized by Treatment Feasibility in Cervical Cancer: Phase II Trial Comparison of 3 vs 4 Fractions (BRACHY-FIT)
Led by Stanford University · Updated on 2025-06-15
41
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the feasibility of a shorter high dose rate (HDR) brachytherapy regimen for patients with locally advanced cervical cancer. This non-randomized Phase II trial compares a 3-fraction HDR brachytherapy schedule against the standard 4-fraction schedule. The study aims to determine whether the shorter 3-fraction regimen can be safely delivered based on specific dosimetric criteria during treatment planning. Participants who meet certain dosimetric thresholds at their first brachytherapy session will receive the investigational 3-fraction regimen, consisting of 8 Gy per fraction for a total of 24 Gy. Those who do not meet these criteria will receive the standard care 4-fraction regimen, with 7 Gy per fraction totaling 28 Gy. The treatment allocation is based on individualized planning rather than random assignment. During the study, researchers will monitor how many patients can complete the 3-fraction regimen within about 8 months. Patients will undergo standard evaluations including clinical assessments and imaging as required for brachytherapy planning and delivery. Safety and treatment feasibility will be closely followed, with participation lasting through the treatment period and follow-up as scheduled by the clinical team.
CONDITIONS
Brief Title
Phase II Trial Comparison of 3 vs 4 Fractions (BRACHY-FIT).
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically documented malignancy of the cervix and planned to receive brachytherapy as part of definitive treatment.
- ECOG performance status of 0-2
- Age 2 18 years old.
- Ability to understand and the willingness to provide written informed consent.
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to treatment completion (typically several weeks)
Participants receive high-dose-rate brachytherapy in either 3 or 4 fractions based on individual dosimetric criteria.
3 to 4 treatment visits (in-person)
Trial Site Locations
Total: 1 location
1
Stanford University
Palo Alto, California, United States, 94304
Actively Recruiting
Research Team
A
Alyssa Alyssa
J
Jillian Skerchak
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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