Phase II Trial Comparison of 3 vs 4 Fractions (BRACHY-FIT).
ConditionCervical Cancers
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorStanford University
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
3-Fraction HDR Brachytherapy
Radiation8 Gy per fraction for 3 fractions (total 24 Gy) for patients with locally advanced cervical cancer, based on individualized planning.
4-Fraction HDR Brachytherapy
Radiation7 Gy per fraction for 4 fractions (total 28 Gy) as the standard-of-care brachytherapy regimen.
Treatment groups
41 Participants
are divided into 2 treatment groupsGroup A: 3-Fraction Brachytherapy ArmExperimental treatment 1 intervention
Group B: Investigational TreatmentActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Proportion of Patients Receiving 3-Fraction Brachytherapy Regimen
Proportion of patients that underwent a 3 fraction brachytherapy regimen.
Time frame
Up to 8 monthsSponsors and contacts
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Source ClinicalTrials.gov