Phase II Trial Comparison of 3 vs 4 Fractions (BRACHY-FIT).
NCT ID: NCT07022470
Last Updated: 2025-06-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
41 participants
INTERVENTIONAL
2025-06-03
2028-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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3-Fraction Brachytherapy Arm
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).
3-Fraction HDR Brachytherapy
8 Gy per fraction for 3 fractions (total 24 Gy) for patients with locally advanced cervical cancer, based on individualized planning.
Investigational Treatment
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).
4-Fraction HDR Brachytherapy
7 Gy per fraction for 4 fractions (total 28 Gy) as the standard-of-care brachytherapy regimen.
Interventions
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3-Fraction HDR Brachytherapy
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
7 Gy per fraction for 4 fractions (total 28 Gy) as the standard-of-care brachytherapy regimen.
Eligibility Criteria
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Inclusion Criteria
* 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 MRI.
* Prior radiation to the pelvis \> 3 months ago
* Age \< 18 years old.
* Pregnant or breast-feeding
18 Years
ALL
No
Sponsors
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Stanford University
OTHER
Responsible Party
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Principal Investigators
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Elizabeth Kidd, MD
Role: PRINCIPAL_INVESTIGATOR
Stanford University
Locations
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Stanford University
Palo Alto, California, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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IRB-79234
Identifier Type: -
Identifier Source: org_study_id
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