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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
3-Fraction Brachytherapy Arm 		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
    8 Gy per fraction for 3 fractions (total 24 Gy) for patients with locally advanced cervical cancer, based on individualized planning.
Active Comparator
Investigational Treatment 		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
    7 Gy per fraction for 4 fractions (total 28 Gy) as the standard-of-care brachytherapy regimen.

Recruiting Locations

Stanford University
Palo Alto, California 94304
Contact:
Alyssa Yauger
650-498-5271
ayauger@stanford.edu

More Details

NCT ID
NCT07022470
Status
Recruiting
Sponsor
Stanford University

Study Contact

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

Notice

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Vanderbilt University Medical Center