Brachytherapy Fractionation Individualized by Treatment Feasibility in Cervical Cancer: Phase II Trial Comparison of 3 vs 4 Fractions (BRACHY-FIT).
Stanford University
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy 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
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.
Location
- Stanford UniversityPalo Alto, California