Definitive Hypofractionated Intensity-modulated Radiation Theraphy With Concurrent Chemotherapy in Cervical Cancer: A Prospective Phase II Trial (DEHIM_CCRT Trial)
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.
• Histologically confirmed cervical cancer (squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma)
• FIGO stage IIB-IVA (2018)
• Measurable primary tumor on pelvic MRI within 30 days prior to treatment initiation
• Age ≥ 20 years
• ECOG performance status 0-1
• Adequate bone marrow function: WBC ≥ 3,000/µL, ANC ≥ 1,000/µL, platelets ≥ 100,000/µL, hemoglobin ≥ 9 g/dL
• Adequate renal function: Creatinine \< 2.0 mg/dL
• Ability to provide written informed consent