Phase II Study Comparing 3-Fraction Versus 4-Fraction High Dose Rate Brachytherapy for Treating Locally Advanced Cervical Cancer

What this Trial Is About

Researchers are evaluating the feasibility of delivering high dose rate brachytherapy in 3 fractions compared to the standard 4 fractions for patients with locally advanced cervical cancer. This Phase II clinical trial aims to compare these two radiation regimens to determine if the shorter 3-fraction course can be safely administered based on individualized treatment planning. The study is sponsored by Stanford University and follows a non-randomized parallel design. Participants who meet specific dosimetric criteria during their first brachytherapy session will receive the investigational 3-fraction regimen, delivering a total of 24 Gy 8 Gy per fraction. Those who do not meet these criteria will follow the standard institutional regimen of 4 fractions, totaling 28 Gy 7 Gy per fraction. Treatment is tailored based on tumor volume and organ-at-risk constraints assessed with imaging. Throughout the study, participants will undergo brachytherapy sessions as scheduled and receive monitoring to assess treatment feasibility. The primary outcome is the proportion of patients who successfully receive the 3-fraction brachytherapy regimen, measured up to 8 months. Participants will be followed for treatment response and safety until study completion, which is anticipated by June 2028.

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