Study of Accelerated Brachytherapy Combined With Hypofractionated Chemoradiation for Locally Advanced Cervical Cancer

What this Trial Is About

Researchers are studying a treatment approach for locally advanced cervical cancer, specifically stages IB3 to IVA according to FIGO 2018 criteria. The study aims to evaluate the impact of combining upfront brachytherapy with hypofractionated external beam radiation therapy on late gastrointestinal and genitourinary side effects, cancer control outcomes such as recurrence-free survival, and immune system responses. This is a phase 1 and 2 interventional trial sponsored by Washington University School of Medicine. The treatment being studied, called Accelerated Brachytherapy Forward Chemo Radiation Therapy ABC-RT, involves giving two fractions of brachytherapy before starting chemoradiotherapy with hypofractionated external beam radiation and concurrent chemotherapy. The radiation doses include 19.05 Gy to the central pelvis, 40 Gy to nodal basins, and a higher dose of 48 Gy to grossly positive lymph nodes, all delivered in 15 fractions. The brachytherapy boost is given as six fractions of 7.3 Gy each. The overall treatment duration from planning to completion is approximately 36 to 42 days. Participants will be monitored for late treatment-related side effects occurring between day 91 and up to two years after treatment. The study will also track cancer recurrence locally and regionally, as well as progression-free survival during this follow-up. Assessments include clinical evaluations and safety monitoring throughout the study period. The total participation time can last up to about two years and six weeks, allowing researchers to gather long-term data on treatment effects and outcomes.

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