RecruitingPhase 3NCT07709650

Hypofractionated Chemoradiotherapy for Cervical Cancer

HYPOfractionated Whole Pelvic Concurrent Chemoradiotherapy in Cervical Cancer (HYPOCx Trial): A Phase III Randomized Controlled Trial


Sponsor

Mahidol University

Enrollment

250 participants

Start Date

Aug 3, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this clinical trial is to evaluate whether hypofractionated whole pelvic or extended-field concurrent chemoradiotherapy can improve treatment access and efficiency while potentially providing superior oncologic efficacy and safety compared to conventional chemoradiotherapy in patients with early-stage node-positive and locally advanced cervical cancer. Building on encouraging safety and efficacy outcomes from our Phase II HYPOCx-iRex trial (TCTR20210812003), this study will provide data for a critical evidence gap regarding the safety, feasibility, and oncologic efficacy of hypofractionated radiotherapy, including extended-field para-aortic treatment, delivered with concurrent chemotherapy. The main questions it aims to answer are: * Does hypofractionated chemoradiotherapy achieve superior nodal control compared to conventional chemoradiotherapy? * Does hypofractionated chemoradiotherapy achieve superior overall survival compared to conventional chemoradiotherapy? Researchers will compare patients receiving hypofractionated external beam radiotherapy to those receiving conventional fractionation to evaluate if the shortened hypofractionated schedule provides comparable disease control, acceptable toxicity, improved quality of life, and cost-effectiveness. Participants will: * Be randomized to receive either hypofractionated external beam radiotherapy or conventional fractionation radiotherapy, both delivered using modern IMRT/VMAT techniques targeting either the whole pelvis or extended fields (including para-aortic lymph nodes). * Receive concurrent platinum-based chemotherapy during external beam radiation. * Complete image-guided adaptive brachytherapy following external beam radiotherapy. * Attend scheduled follow-up visits to evaluate tumor response, disease control, treatment-related toxicities, quality of life, and survival outcomes.


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Concurrent chemotherapy, Conventional Chemoradiotherapy, and others for people with cervival cancer. The study is currently recruiting participants at 1 location.

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 Chemoradiotherapy

Whole pelvic external beam radiotherapy delivered using IMRT or VMAT techniques at a dose of 44 Gy in 20 fractions (2.2 Gy per fraction), administered once daily, five fractions per week. Treatment is given concurrently with weekly platinum-based chemotherapy and followed by image-guided adaptive brachytherapy according to institutional protocols.

RADIATIONConventional Chemoradiotherapy

Whole pelvic external beam radiotherapy delivered using IMRT or VMAT techniques at a dose of 45 Gy in 25 fractions (1.8 Gy per fraction), administered once daily, five fractions per week. Treatment is given concurrently with weekly platinum-based chemotherapy and followed by image-guided adaptive brachytherapy according to institutional protocols.

DRUGConcurrent chemotherapy

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.


Locations(1)

Siriraj Hospital

Bangkok Noi, Bangkok, Thailand

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NCT07709650