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

NCT06529809 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2025-12-24

No results posted yet for this study

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.

Conditions

  • Locally Advanced Cervical Carcinoma

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

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Washington University School of Medicine

    lead OTHER

Principal Investigators

  • Jessika A Contreras, M.D. · Washington University School of Medicine

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-11
Primary Completion
2031-12-31
Completion
2031-12-31
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06529809 on ClinicalTrials.gov