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

NCT07022470 | Recruiting Phase 2

• 1 other identifier: IRB-79234
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cervical Cancers

Keywords

high dose rate brachytherapy

Outcome Measures

Primary Outcomes (1)

• Proportion of Patients Receiving 3-Fraction Brachytherapy Regimen

  Proportion of patients that underwent a 3 fraction brachytherapy regimen.

  Up to 8 months

Study Arms (2)

3-Fraction Brachytherapy Arm

EXPERIMENTAL

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).

Radiation: 3-Fraction HDR Brachytherapy

Investigational Treatment

ACTIVE COMPARATOR

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).

Radiation: 4-Fraction HDR Brachytherapy

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.

3-Fraction Brachytherapy Arm

4-Fraction HDR Brachytherapy RADIATION

7 Gy per fraction for 4 fractions (total 28 Gy) as the standard-of-care brachytherapy regimen.

Investigational Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Pregnant or breast-feeding

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University

Palo Alto, California, 94304, United States

RECRUITING

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Elizabeth Kidd, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alyssa Alyssa

CONTACT

(650) 498-5271; ayauger@stanford.edu

Jillian Skerchak

CONTACT

(650) 721-4072; jskerch1@stanford.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2025
• First Posted: June 15, 2025
• Study Start: June 3, 2025
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: June 15, 2025

Record last verified: 2025-06

Locations

US (1)