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

Part of paid clinical trials in Palo Alto, California.

Sponsor
Stanford University
Study ID
NCT07022470
Phase
PHASE2
Status
Recruiting
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Conditions

  • Cervical Cancers

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Jun 3, 2025
Status verified
Jun 2025
Primary completion
Jun 30, 2028
Completion
Jun 30, 2028

Study Design

Enrollment
41 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 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).
  • Active Comparator: 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).

Primary Outcome Measure

Proportion of Patients Receiving 3-Fraction Brachytherapy Regimen [ Time Frame: Up to 8 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Stanford UniversityPalo AltoCalifornia94304
Alyssa Yauger
[email protected]
650-498-5271
Jillian Skerchak
[email protected]
(650) 721-4072
Elizabeth Kidd, MD (PRINCIPAL_INVESTIGATOR)

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