NCT07022470PHASE2Recruiting

Phase II Trial Comparison of 3 vs 4 Fractions (BRACHY-FIT).

Stanford University

Start Date

6/3/2025

Completion Date

6/1/2028

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 Criteria

Age Range: 18 years to No maximum

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

RADIATION

3-Fraction HDR Brachytherapy

RADIATION

4-Fraction HDR Brachytherapy

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Conditions

Cervical Cancers

Locations

Stanford University

Palo Alto, California 94304

United States