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

NCT07439497 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2026-02-27

No results posted yet for this study

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.

Conditions

Interventions

RADIATION

Definitive 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.

DRUG

concurrent 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.

Sponsors & Collaborators

  • Samsung Medical Center

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-09
Primary Completion
2026-05-30
Completion
2028-05-30

Countries

  • South Korea

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 NCT07439497 on ClinicalTrials.gov