Hypofractionated Chemoradiotherapy for Cervical Cancer

NCT07709650 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2026-07-16

No results posted yet for this study

Summary

Cervical cancer remains a major health problem in Thailand and other lowand middle-income countries. The current standard treatment for locally advanced cervical cancer consists of conventionally fractionated external beam radiotherapy delivered over 5-7 weeks with concurrent chemotherapy, followed by brachytherapy. This prolonged treatment schedule requires frequent hospital visits and may limit access to care. Hypofractionated radiotherapy delivers a higher dose of radiation per treatment session while maintaining a comparable total radiation dose, thereby reducing the overall treatment duration. Preliminary studies suggest that hypofractionated chemoradiotherapy using modern radiotherapy techniques may provide similar disease control and acceptable toxicity compared with conventional treatment, while improving treatment convenience and reducing healthcare burden. This multicenter phase III randomized controlled trial aims to compare hypofractionated whole pelvic concurrent chemoradiotherapy with conventional chemoradiotherapy in patients with early-stage node-positive and locally advanced cervical cancer. The study will evaluate nodal control and overall survival, as well as tumor response, treatment-related toxicities, quality of life, and cost-effectiveness.

Conditions

  • Cervival Cancer

Interventions

RADIATION

Hypofractionated 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.

RADIATION

Conventional 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.

DRUG

Concurrent 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.

Sponsors & Collaborators

  • Chiang Mai University

    collaborator OTHER
  • Prince of Songkla University

    collaborator OTHER
  • Siriraj Hospital

    collaborator OTHER
  • Ratchaburi Hospital

    collaborator OTHER
  • Tha Chalom Hospital

    collaborator UNKNOWN
  • Chulabhorn Hospital

    collaborator OTHER
  • Lopburi Hospital

    collaborator UNKNOWN
  • Mahidol University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-31
Primary Completion
2031-06-30
Completion
2033-06-30

Countries

  • Thailand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07709650 on ClinicalTrials.gov