RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Brachytherapy Fractionation Individualized by Treatment Feasibility in Cervical Cancer: Phase II Trial Comparison of 3 vs 4 Fractions (BRACHY-FIT).

Quick Facts

Study Start:2025-06-03
Study Completion:2028-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07022470

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Histologically documented malignancy of the cervix and planned to receive brachytherapy as part of definitive treatment.
  2. * ECOG performance status of 0-2
  3. * Age ≥ 18 years old.
  4. * Ability to understand and the willingness to provide written informed consent.
  1. * Contraindication to receiving radiotherapy as determined by treating radiation oncologist.
  2. * Contraindication to receiving MRI.
  3. * Prior radiation to the pelvis \> 3 months ago
  4. * Age \< 18 years old.
  5. * Pregnant or breast-feeding

Contacts and Locations

Study Contact

Alyssa Alyssa
CONTACT
(650) 498-5271
ayauger@stanford.edu
Jillian Skerchak
CONTACT
(650) 721-4072
jskerch1@stanford.edu

Principal Investigator

Elizabeth Kidd, MD
PRINCIPAL_INVESTIGATOR
Stanford University

Study Locations (Sites)

Stanford University
Palo Alto, California, 94304
United States

Collaborators and Investigators

Sponsor: Stanford University

  • Elizabeth Kidd, MD, PRINCIPAL_INVESTIGATOR, Stanford University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-06-03
Study Completion Date2028-06

Study Record Updates

Study Start Date2025-06-03
Study Completion Date2028-06

Terms related to this study

Keywords Provided by Researchers

  • high dose rate brachytherapy

Additional Relevant MeSH Terms

  • Cervical Cancers