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

Stanford University

Status and phase: Enrolling; Phase 2

Conditions: Cervical Cancers

Treatments: Radiation: 3-Fraction HDR Brachytherapy; Radiation: 4-Fraction HDR Brachytherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT07022470

IRB-79234

Details and patient eligibility

About

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.

Enrollment: 41 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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41 participants in 2 patient groups

3-Fraction Brachytherapy Arm

Experimental group

Description:

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).

Treatment:

Radiation: 3-Fraction HDR Brachytherapy

Investigational Treatment

Active Comparator group

Description:

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).

Treatment:

Radiation: 4-Fraction HDR Brachytherapy