Recruiting
Phase 2

High Dose Rate Brachytherapy

Sponsor:

Stanford University

Code:

NCT07022470

Conditions

Cervical Cancers

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

3-Fraction HDR Brachytherapy

4-Fraction HDR Brachytherapy

Study Details

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

Study ID

NCT07022470

Start date

Jun 3, 2025

Status verified date

Jun, 2026

Completion date

Jun, 2028

Anticipated

Primary completion date

Jun, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

41 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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).

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).

Interventions

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.

4-Fraction HDR Brachytherapy

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

Primary outcome measure

  • Proportion of Patients Receiving 3-Fraction Brachytherapy Regimen [ Time Frame: Up to 8 months ]

Central Contacts and Locations

Central contacts

Alyssa Yauger

(650) 498-5271ayauger@stanford.edu

Jillian Skerchak

(650) 721-4072jskerch1@stanford.edu

Locations

Stanford University

Recruiting

Palo Alto, California, United States, 94304

Contacts

Alyssa Yauger

650-498-5271ayauger@stanford.edu

Jillian Skerchak

(650) 721-4072jskerch1@stanford.edu

Principal Investigator:

Elizabeth Kidd, MD

More Information

Sponsor

Stanford University

Last update posted

Jun 12, 2026

Last verified

Jun, 2026

Keywords

  • high dose rate brachytherapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Stanford University on 2026-06-12.