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

Phase 2

Recruiting

• Conditions: Cervical Cancers

• Registration Number: NCT07022470
• Lead Sponsor: Stanford University

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-06
• Study Start: 2025-06-03
• Study First Submitted: 2025-06-06
• Study First Submitted QC: 2025-06-06
• Last Update Submitted: 2025-06-06
• Study First Posted: 2025-06-15
• Last Update Posted: 2025-06-15
• Primary Completion: 2028-06
• Study Completion: 2028-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 41

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Proportion of Patients Receiving 3-Fraction Brachytherapy Regimen	Up to 8 months	Proportion of patients that underwent a 3 fraction brachytherapy regimen.

Trial Locations

Locations (1)

Stanford University; 🇺🇸 Palo Alto, California, United States