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Hypofractionated Chemoradiotherapy for Cervical Cancer

Study acronym: HYPOCx
StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Notable Recruitment opened Start date changed from estimate of Aug 2026 to Aug 3, 2026 · Secondary endpoints: details revised at 1 of 11 entries · Study description expanded, about 13 words · 2 morev2 Show 5 more changesShow less
    • Start date changed from estimate of Aug 2026 to Aug 3, 2026
    • Secondary endpoints: details revised at 1 of 11 entries
    • Study description expanded, about 13 words
    • Site details revised
    • Collaborators: 7 to 1

    See this version in full on ClinicalTrials.gov ↗

  2. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07709650
Lead Sponsor Mahidol University
Collaborators: Siriraj Hospital
Conditions Cervival Cancer
Enrollment 250 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov