Phase II Trial Comparison of 3 vs 4 Fractions (BRACHY-FIT).
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 3-Fraction HDR Brachytherapy, 4-Fraction HDR Brachytherapy.
- Who it may be relevant to
- Registry conditions: Cervical Cancers. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Brachytherapy Fractionation Individualized by Treatment Feasibility in Cervical Cancer: Phase II Trial Comparison of 3 vs 4 Fractions (BRACHY-FIT).
Overview
This is a prospective non-randomized clinical trial to evaluate the feasibility of 3 fraction versus a standard 4 fraction high dose rate brachytherapy regimen in patients with locally advanced cervical cancer.
Interventions
- Radiation 3-Fraction HDR Brachytherapy
8 Gy per fraction for 3 fractions (total 24 Gy) for patients with locally advanced cervical cancer, based on individualized planning. - Radiation 4-Fraction HDR Brachytherapy
7 Gy per fraction for 4 fractions (total 28 Gy) as the standard-of-care brachytherapy regimen.
Primary outcome measures
- Proportion of Patients Receiving 3-Fraction Brachytherapy Regimen [Time frame: Up to 8 months]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Stanford University — Palo Alto
Identifiers
NCT: NCT07022470 · IRB-79234 · NCI-2025-06274