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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
34
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.
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.
Samsung Medical Center
Seoul, Gangnam-gu, South Korea
RECRUITINGTumor Volume Redution Rate (TVRR) at 1 month after completion of treatment based on MRI
Time frame: 1 month after completion of treatment
3 years local recurrence
Time frame: 3 years after treatment initiation
3 years progression-free survival (PFS)
Time frame: 3 years after treatment initiation
incidence of acute and late adverse events ≥ Grade 3
Time frame: During RT treatment to Post RT 3 years
Prognostic factor analysis for local recurrence and progression-free survival
Time frame: 3 years after treatment initiation
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