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

  • PhasePhase 2
  • StatusRecruiting
  • Planned enrollment41 people
  • Recruiting US sites1
  • SponsorStanford University
  • RegistryNCT07022470

Recruitment re-checked on ClinicalTrials.gov Oct 30, 2026. Public record; not medical advice.

Phase II Trial Comparison of 3 vs 4 Fractions (BRACHY-FIT).: a one-minute explainerNCT070224701 min

Eligibility

Who can join

The film gives the main points. The full list below is copied from the registry; the study team makes the final decision.

  • Age18 Years to no maximum
  • SexAll
  • Healthy volunteersNo

You may be able to join if

  • 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.

You cannot join if

  • 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

The treatment

How it is intended to work

This is how the treatment is meant to work. Whether it helps, and how safe it is, is what this trial is testing.

Treatments listed in the registry

  • 3-Fraction HDR Brachytherapy (Radiation): 8 Gy per fraction for 3 fractions (total 24 Gy) for patients with locally advanced cervical cancer, based on individualized planning.
  • 4-Fraction HDR Brachytherapy (Radiation): 7 Gy per fraction for 4 fractions (total 28 Gy) as the standard-of-care brachytherapy regimen.

The study

Treatment groups

Non Randomized · Parallel · masking: None

3-Fraction Brachytherapy Arm (Experimental)

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).

Investigational Treatment (Active Comparator)

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).

Goals

What the study measures

Main goals

  • Proportion of Patients Receiving 3-Fraction Brachytherapy Regimen (Up to 8 months)

Planned enrollment: 41 (estimated).

Where

Recruiting US sites

  • Stanford University, Palo Alto, California

Site status as of Oct 30, 2026. Check the live record before contacting a site.

Sources

Where this comes from

Registry record reviewed as fetched Oct 30, 2026, last updated by the sponsor Jun 11, 2026. Public record; not medical advice.

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