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NCT Number: NCT07022470

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

4-Fraction HDR Brachytherapy

Radiation

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

Primary outcomes

  1. Proportion of Patients Receiving 3-Fraction Brachytherapy Regimen

    Time frame: Up to 8 months

    Proportion of patients that underwent a 3 fraction brachytherapy regimen.

Study contacts

Contact information is provided by the study sponsor or research team.

Alyssa Yauger

CONTACT

[email protected]

(650) 498-5271

Jillian Skerchak

CONTACT

[email protected]

(650) 721-4072

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Jun 15, 2025
Registry last updated
Jun 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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