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Reduced vs Conventional Dosage Intensity-modulated Radiotherapy for Chemotherapy-sensitive Stage II-III Nasopharyngeal Carcinoma
Sponsor: Sun Yat-sen University
Summary
Through multicenter, open-label, randomised clinical trials, we intend to demonstrate that radiotherapy with reduced dose could significantly reduce the incidence of radiotherapy toxicities, improve the quality of life of patients while ensuring the tumor control rates for NPC patients staged as II-III who are sensitive to induction chemotherapy (imaging evaluation of CR/PR and EBV DNA copy number decreased to 0 copies/mL after induction chemotherapy)
Official title: A Multicenter Randomized Controlled Trial Comparing Reduced Dose With Regular Dose Intensity-modulated Radiotherapy for Chemotherapy Sensitive Stage II-III Nasopharyngeal Carcinoma
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
508
Start Date
2020-08-18
Completion Date
2028-08
Last Updated
2020-09-28
Healthy Volunteers
No
Interventions
reduced dosage IMRT
1. Gemcitabine plus cisplatin induction chemotherapy: gemcitabine is injected intravenously at the dose of 1000 mg/m2 on the 1st and 8th day (within 30 minutes) for 3 cycles; cisplatin is injected intravenously at the dose of 80 mg/m2 on the 1st day, for 3 cycles. 1 cycles per 3 weeks. 2. Concurrent cisplatin chemotherapy: cisplatin is given at a dose of 100 mg/m2 via a continuous intravenous infusion during radiotherapy and starts on the 1st day of radiotherapy for 2 cycles. 1 cycles per 3 weeks. 3. IMRT: PTVnx:63.6Gy/30Fr/2.12Gy; PTVnd:63.6Gy/30Fr/2.12Gy; PTV1:54Gy/30Fr/1.8Gy; PTV2:49.2Gy/30Fr/1.64Gy
conventional dosage IMRT
1. Gemcitabine plus cisplatin induction chemotherapy: gemcitabine is injected intravenously at the dose of 1000 mg/m2 on the 1st and 8th day (within 30 minutes) for 3 cycles; cisplatin is injected intravenously at the dose of 80 mg/m2 on the 1st day, for 3 cycles. 1 cycles per 3 weeks. 2. Concurrent cisplatin chemotherapy: cisplatin is given at a dose of 100 mg/m2 via a continuous intravenous infusion during radiotherapy and starts on the 1st day of radiotherapy for 2 cycles. 1 cycles per 3 weeks. 3. IMRT: PTVnx:69.96Gy/33Fr/2.12Gy; PTVnd:69.96Gy/33Fr/2.12Gy; PTV1:59.4Gy/33Fr/1.8Gy; PTV2:54Gy/33Fr/1.64Gy
Locations (6)
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Cancer Center of Guangzhou Medical University
Guangzhou, Guangdong, China
Yuebei People's Hospital
Shaoguan, Guangdong, China
Zhongshan People's Hospital
Zhongshan, Guangdong, China
Wuzhou Red Cross Hospital
Wuzhou, Guangxi, China
National Cancer Centre Singapore
Singapore, Singapore