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
Qualifiers
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
Treatments tested in this trial
- 3-Fraction HDR Brachytherapy
- 4-Fraction HDR Brachytherapy
Treatment groups
41 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov