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RecruitingInterventionalPhase 2
Brachytherapy Fractionation Individualized by Treatment Feasibility in Cervical Cancer: Phase II Trial Comparison of 3 vs 4 Fractions (BRACHY-FIT).
NCT ID: NCT07022470Sponsor: Stanford UniversityLast updated: 2026-06-12
Summary
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.
Arms & interventions
- Radiation3-Fraction HDR Brachytherapy
8 Gy per fraction for 3 fractions (total 24 Gy) for patients with locally advanced cervical cancer, based on individualized planning.
- Radiation4-Fraction HDR Brachytherapy
7 Gy per fraction for 4 fractions (total 28 Gy) as the standard-of-care brachytherapy regimen.
Outcome measures
Primary
Proportion of Patients Receiving 3-Fraction Brachytherapy Regimen
Proportion of patients that underwent a 3 fraction brachytherapy regimen.
Time frame: Up to 8 months
Eligibility criteria
Sex: AllAge: 18 Years and olderHealthy volunteers: No
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
Study locations (1)
Stanford University
Palo Alto, California, 94304
Elizabeth Kidd, MD · Principal Investigator