Hypofractionated Chemoradiotherapy for Cervical Cancer

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18+
SponsorMahidol University

About this trial

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.

Eligibility criteria

Qualifiers

Cancer of the uterine cervix considered suitable for curative treatment with definitive radio-(chemo)therapy including imaged-guided BT

Positive biopsy showing squamous-cell carcinoma, adenocarcinoma, or adeno-squamous cell carcinoma of the uterine cervix

Locally advanced staging according to FIGO 2018 and TNM guidelines (Stage IA1-IVA)

MRI of the pelvis at diagnosis is performed

Disqualifiers

Other primary malignancies except carcinoma in situ of the cervix and basal cell carcinoma of the skin

Small cell neuroendocrine cancer, melanoma and other rare cancers in the cervix

Metastatic disease beyond intervertebral disc L2/3 level

Previous pelvic or abdominal radiotherapy

Trial design

Treatments tested in this trial

  • Hypofractionated Chemoradiotherapy
  • Conventional Chemoradiotherapy
  • Concurrent chemotherapy

Treatment groups

250 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Mahidol University

Lead sponsor

Chiang Mai University

Collaborator

Prince of Songkla University

Collaborator

Siriraj Hospital

Collaborator

Ratchaburi Hospital

Collaborator

Tha Chalom Hospital

Collaborator

Chulabhorn Hospital

Collaborator

Lopburi Hospital

Collaborator