RecruitingPhase 1Phase 2NCT06529809

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


Sponsor

Washington University School of Medicine

Enrollment

50 participants

Start Date

Feb 11, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a treatment approach for locally advanced cervical cancer that combines chemoradiation (chemotherapy with radiation) with brachytherapy (internal radiation placed close to the tumor) in an accelerated (faster) schedule, to see if it is as effective and safe as standard treatment. **You may be eligible if...** - You have been newly diagnosed with locally advanced cervical cancer (FIGO stage IB3–IVA) - Your cancer type is squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma of the cervix - Your doctor has recommended radiation therapy as the primary treatment **You may NOT be eligible if...** - You have had previous treatment for cervical cancer - Your cancer has spread beyond the pelvis (stage IVB) - You are pregnant - You have other serious medical conditions that make radiation therapy unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONHypofractionated 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)

DRUGChemotherapy

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

RADIATIONImage-guided brachytherapy

HDR boost 7.3 Gy x 6 fractions


Locations(1)

Washington University School of Medicine

St Louis, Missouri, United States

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NCT06529809


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