RecruitingPhase 2NCT07439497

Definitive Hypofractionated Intensity-modulated Radiation Theraphy With Concurrent Chemotherapy in Cervical Cancer

Definitive Hypofractionated Intensity-modulated Radiation Theraphy With Concurrent Chemotherapy in Cervical Cancer: A Prospective Phase II Trial (DEHIM_CCRT Trial)


Sponsor

Samsung Medical Center

Enrollment

34 participants

Start Date

Dec 9, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This study aims to evaluate the efficacy and safety of hypofractionated intensity-modulated radiation therapy (IMRT) combined with concurrent chemotherapy in patients with cervical cancer. Conventional treatment usually requires 7-8 weeks, which increases the risk of toxicities and treatment delays. This trial seeks to shorten the overall treatment time while maintaining non-inferior tumor response and survival outcomes compared to standard therapy. The primary endpoint is tumor volume reduction rate (TVRR) assessed by pelvic MRI at 1 month after treatment. Secondary endpoints include 3-year local recurrence rate, progression-free survival, and incidence of acute and late grade ≥3 toxicities. The results of this study are expected to contribute to establishing an optimal treatment strategy for cervical cancer.


Eligibility

Sex: FEMALEMin Age: 20 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a shorter, more intense course of radiation therapy (called hypofractionated IMRT) combined with chemotherapy as a treatment for locally advanced cervical cancer. The goal is to see if this condensed schedule is as effective as the standard approach while being more convenient for patients. **You may be eligible if...** - You have been diagnosed with cervical cancer confirmed by biopsy (squamous cell, adenocarcinoma, or adenosquamous types) - Your cancer is stage IIB through IVA (advanced but not spread outside the pelvis) - You are 20 years or older - You are in good enough health to tolerate treatment (ECOG 0–1) - Your blood counts and kidney function are within acceptable ranges **You may NOT be eligible if...** - Your cancer has spread to distant organs (metastatic) - You have had prior pelvic radiation - You have already received chemotherapy or chemoradiation for cervical cancer - You have had surgery for this cancer - You have had a cervical cone biopsy or LEEP procedure before radiation - You have another active cancer (except minor skin cancers or early bladder cancer) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONDefinitive hypofractionated intensity-modulated radiation theraphy

Patients receive weekly cisplatin at 40 mg/m² intravenously on days 1, 8, 15, 22, and 29, concurrently with external beam radiotherapy (EBRT). EBRT is delivered to the pelvic nodal regions at 1.8-2.0 Gy per fraction up to a total dose of 40-50 Gy. Sequential EBRT boost of 10-20 Gy to grossly positive nodal disease or 5-10 Gy to the parametrium may be applied if needed. The overall treatment course lasts approximately 7-8 weeks, and intracavitary brachytherapy (ICR) may be additionally performed when indicated.

DRUGconcurrent chemotherapy

Patients receive weekly cisplatin at 40 mg/m² intravenously on days 1, 8, 15, 22, and 29, concurrently with external beam radiotherapy (EBRT). EBRT is delivered to the pelvic nodal regions at 1.8-2.0 Gy per fraction up to a total dose of 40-50 Gy. Sequential EBRT boost of 10-20 Gy to grossly positive nodal disease or 5-10 Gy to the parametrium may be applied if needed. The overall treatment course lasts approximately 7-8 weeks, and intracavitary brachytherapy (ICR) may be additionally performed when indicated.


Locations(1)

Samsung Medical Center

Seoul, Gangnam-gu, South Korea

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NCT07439497


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