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Hypofractionated Whole Pelvic Chemoradiotherapy With iRex Optimization in Cervical Cancer

NCT07605507 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-05-26

No results posted yet for this study

Summary

This study is a randomized controlled trial designed to compare hypofractionated whole pelvic radiotherapy with conventional radiotherapy in patients with cervical cancer undergoing concurrent chemoradiotherapy.

Hypofractionated radiotherapy delivers a higher dose per treatment over a shorter overall treatment time, which may reduce the number of hospital visits and improve treatment convenience for patients. Conventional radiotherapy requires more treatment sessions over a longer period.

The purpose of this study is to evaluate whether hypofractionated radiotherapy is as safe and effective as conventional radiotherapy. The primary outcomes focus on treatment-related toxicity, while secondary outcomes include tumor response, survival outcomes, quality of life, and treatment-related factors.

In addition, this study will evaluate a novel planning approach called the indirect excess dose volume ratio (iRex) to optimize brachytherapy planning and potentially reduce radiation-related side effects.

Conditions

Interventions

RADIATION

Hypofractionated Radiotherapy

Whole pelvic radiotherapy delivered using hypofractionation (2.2 Gy per fraction over 20 fractions) with IMRT.

RADIATION

Conventional Radiotherapy

Whole pelvic radiotherapy delivered using conventional fractionation (1.8 Gy per fraction over 25 fractions) with IMRT.

DRUG

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.

PROCEDURE

Image-guided Adaptive Brachytherapy

Image-guided adaptive brachytherapy delivered following external beam radiotherapy.

PROCEDURE

iReX Optimization

Brachytherapy treatment planning optimized using iReX in addition to standard D2cc constraints.

PROCEDURE

Standard D2cc Planning

Conventional brachytherapy treatment planning using standard D2cc constraints without iReX optimization.

Sponsors & Collaborators

  • Siriraj Hospital

    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
2021-07-15
Primary Completion
2028-07-31
Completion
2028-07-31

Countries

  • Thailand

Study Locations

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Entities

Diseases

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 NCT07605507 on ClinicalTrials.gov