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RECRUITING
NCT06529809
PHASE1/PHASE2

Accelerated Brachytherapy Forward Chemo Radiation Therapy (ABC-RT) for Locally-advanced Cervical Cancer

Sponsor: Washington University School of Medicine

View on ClinicalTrials.gov

Summary

The standard treatment for locally advanced cervical cancer is well established as a combination of chemotherapy and radiation, typically over 25-28 daily fractions with the addition of a brachytherapy boost to the primary tumor. An important component to treatment efficacy is overall treatment time. Prolongation of overall treatment time has been shown to lead to worse local control and overall survival; thus, strategies to effectively deliver radiation efficiently is required. This is a pragmatic feasibility study to determine the impact of upfront brachytherapy combined with hypofractionated external beam radiation for patients with locally advanced cervical cancer (FIGO 2018 stage IB3-IVA) on late gastrointestinal and genitourinary toxicity, oncologic outcomes including recurrence free survival, and systemic and local immune response.

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2025-02-11

Completion Date

2031-12-31

Last Updated

2025-12-24

Healthy Volunteers

No

Interventions

RADIATION

Hypofractionated external beam radiation

Central pelvis (19.05 Gy in 15 fractions), nodal basins (40 Gy in 15 fractions), with a simultaneous integrated boost to grossly positive lymph nodes (48 Gy in 15 fractions)

DRUG

Chemotherapy

Concurrent chemotherapy are not dictated by the protocol and will follow standard of care guidelines

RADIATION

Image-guided brachytherapy

HDR boost 7.3 Gy x 6 fractions

Locations (1)

Washington University School of Medicine

St Louis, Missouri, United States