Brachytherapy Fractionation Individualized by Treatment Feasibility in Cervical Cancer: Phase II Trial Comparison of 3 vs 4 Fractions (BRACHY-FIT).
Status: Recruiting
Location: See location...
Intervention Type: Radiation
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
United States
California
Stanford University
RECRUITING
Palo Alto
Contact Information
Primary
Alyssa Alyssa
ayauger@stanford.edu
(650) 498-5271
Backup
Jillian Skerchak
jskerch1@stanford.edu
(650) 721-4072
Time Frame
Start Date: 2025-06-03
Estimated Completion Date: 2028-06
Participants
Target number of participants: 41
Treatments
Experimental: 3-Fraction Brachytherapy Arm
Patients who meet dosimetric criteria at the first brachytherapy session (HR CTV D90 \> 85 Gy and acceptable OAR constraints) will receive an investigational 3-fraction HDR brachytherapy regimen (24 Gy total).
Active_comparator: Investigational Treatment
Patients who do not meet dosimetric criteria for the investigational regimen will receive the institutional standard-of-care regimen of 4 fractions (28 Gy total).
Related Therapeutic Areas
Sponsors
Leads: Stanford University