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

Plain Language Summary

Simplified for easier understanding

This study (BRACHY-FIT) is comparing two brachytherapy schedules — 3 radiation sessions versus 4 radiation sessions — in women with cervical cancer receiving brachytherapy (internal radiation therapy placed directly inside or near the tumor) as part of their definitive treatment. **You may be eligible if...** - You are 18 or older - You have histologically confirmed cervical cancer - You are receiving brachytherapy as part of your curative treatment plan - You are generally well enough for treatment (ECOG 0–2) **You may NOT be eligible if...** - You have a medical reason that makes radiation therapy unsafe - You cannot have an MRI scan - You have had prior pelvic radiation more than 3 months ago - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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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