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

Sponsor: Stanford University

Sponsor score: 40

ClinicalTrials ID:NCT07022470

This Phase II trial assesses the feasibility of a 3-fraction (8 Gy each) versus a standard 4-fraction (7 Gy each) HDR brachytherapy regimen in patients with locally advanced cervical cancer. Eligible participants must have a histologically confirmed cervical malignancy, be aged 18 or older, have an ECOG status of 0-2, and provide informed consent.

Patient Parameters

Program Overview

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

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

Locations

FACILITYZIPCITYSTATE
Stanford University94304Palo AltoCalifornia

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