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

Phase 2RecruitingNCT07022470

Stanford University41 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Cervical Cancers

Interventions

3-Fraction HDR BrachytherapyRADIATION

8 Gy per fraction for 3 fractions (total 24 Gy) for patients with locally advanced cervical cancer, based on individualized planning.

4-Fraction HDR BrachytherapyRADIATION

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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. Exclusion Criteria: * 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

Locations (1)

Stanford University

Palo Alto, California, United States

RECRUITING

Outcomes

Primary Outcomes

Proportion of Patients Receiving 3-Fraction Brachytherapy Regimen

Proportion of patients that underwent a 3 fraction brachytherapy regimen.

Time frame: Up to 8 months

Central Contacts

Alyssa Alyssa

CONTACT

(650) 498-5271 ayauger@stanford.edu

Jillian Skerchak

CONTACT

(650) 721-4072 jskerch1@stanford.edu

Data from ClinicalTrials.gov

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