drugset / Trial / NCT07439497

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

NCT07439497 ↗

Phase 2 Recruiting 34 enrolled Samsung Medical Center
NaSingle-groupOpen-labelTreatment

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.

Timeline

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

Drugs

EvaluationDrugModalityDoseRoute
Background Cisplatin Other / unclassified 40 mg/m2 Intravenous

Indications