RecruitingPhase 2NCT07022470

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

Brachytherapy Fractionation Individualized by Treatment Feasibility in Cervical Cancer: Phase II Trial Comparison of 3 vs 4 Fractions (BRACHY-FIT).


Sponsor

Stanford University

Enrollment

41 participants

Start Date

Jun 3, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria4

  • 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 Criteria5

  • 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

Interventions

RADIATION3-Fraction HDR Brachytherapy

8 Gy per fraction for 3 fractions (total 24 Gy) for patients with locally advanced cervical cancer, based on individualized planning.

RADIATION4-Fraction HDR Brachytherapy

7 Gy per fraction for 4 fractions (total 28 Gy) as the standard-of-care brachytherapy regimen.


Locations(1)

Stanford University

Palo Alto, California, United States

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NCT07022470


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