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NOT YET RECRUITING
NCT07709650
PHASE3

Hypofractionated Chemoradiotherapy for Cervical Cancer

Sponsor: Mahidol University

View on ClinicalTrials.gov

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.

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

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

250

Start Date

2026-08

Completion Date

2033-06

Last Updated

2026-07-16

Healthy Volunteers

No

Conditions

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.

Locations (1)

Siriraj Hospital

Bangkok Noi, Bangkok, Thailand