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Hypofractionated Whole Pelvic Chemoradiotherapy With iRex Optimization in Cervical Cancer
Sponsor: Siriraj Hospital
Summary
This study is a randomized controlled trial designed to compare hypofractionated whole pelvic radiotherapy with conventional radiotherapy in patients with cervical cancer undergoing concurrent chemoradiotherapy. Hypofractionated radiotherapy delivers a higher dose per treatment over a shorter overall treatment time, which may reduce the number of hospital visits and improve treatment convenience for patients. Conventional radiotherapy requires more treatment sessions over a longer period. The purpose of this study is to evaluate whether hypofractionated radiotherapy is as safe and effective as conventional radiotherapy. The primary outcomes focus on treatment-related toxicity, while secondary outcomes include tumor response, survival outcomes, quality of life, and treatment-related factors. In addition, this study will evaluate a novel planning approach called the indirect excess dose volume ratio (iRex) to optimize brachytherapy planning and potentially reduce radiation-related side effects.
Official title: HYPOfractionated Whole Pelvic Concurrent Chemoradiotherapy in Cervical (Cx) Cancer With "Indirect Excess Dose Volume Ratio (iRex)" - Optimized Image Guided Adaptive Brachytherapy (HYPOCx-iRex Trial) : A Phase II Non-inferiority Randomized Controlled Trial
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
40
Start Date
2021-07-15
Completion Date
2028-07-31
Last Updated
2026-05-26
Healthy Volunteers
No
Conditions
Interventions
Hypofractionated Radiotherapy
Whole pelvic radiotherapy delivered using hypofractionation (2.2 Gy per fraction over 20 fractions) with IMRT.
Conventional Radiotherapy
Whole pelvic radiotherapy delivered using conventional fractionation (1.8 Gy per fraction over 25 fractions) with IMRT.
Concurrent chemotherapy once a week
Cisplatin-based concurrent chemotherapy administered intravenously at a dose of 40 mg/m² once weekly during external beam radiotherapy for 5 to 6 cycles.
Image-guided Adaptive Brachytherapy
Image-guided adaptive brachytherapy delivered following external beam radiotherapy.
iReX Optimization
Brachytherapy treatment planning optimized using iReX in addition to standard D2cc constraints.
Standard D2cc Planning
Conventional brachytherapy treatment planning using standard D2cc constraints without iReX optimization.
Locations (1)
Siriraj Hospital
Bangkok, Bangkok, Thailand