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Reduced-dose Radiotherapy for Stage III Nasopharyngeal Carcinoma Based on the Treatment Response
Sponsor: Sun Yat-sen University
Summary
This is an Open Label, Non-Inferiority, Multicenter, Randomized Phase 3 Trial aimed to investigate the impact of reduced-dose radiotherapy in combination with chemotherapy and immunotherapy on patients' prognosis and complication compared with conventional-dose radiotherapy in combination with chemotherapy and immunotherapy for treatment-sensitive stage III NPC patients screened out according to the treatment response.
Official title: Reduced-dose Radiotherapy for Stage III Nasopharyngeal Carcinoma Based on the Treatment Response: an Open Label, Non-Inferiority, Multicenter, Randomized Phase 3 Trial
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
593
Start Date
2024-03-01
Completion Date
2030-02-20
Last Updated
2026-03-06
Healthy Volunteers
No
Conditions
Interventions
PD-1 blocking antibody
1. IC phase of PD-1 blocking antibody: every 3 weeks × 3 cycles; 200 mg, day 1; start on day 1 of the first cycle IC and continue every 3 weeks for 3 cycles till the end of IC. 2. Adjuvant PD-1 blocking antibody: every 3 weeks × 9 cycles; 200 mg, day 1.
Gemcitabine
Gemcitabine as induction chemotherapy, 1000 mg/m2 day 1, 8 per cycle, every 3 weeks for 3 cycles.
Cisplatin (80 mg/m2)
Cisplatin as induction chemotherapy, 80 mg/m2 day 1 per cycle, every 3 weeks for 3 cycles.
Reduced-dose Intensity-modulated radiotherapy
1. Definitive IMRT, 30 fractions, 5 fractions/week, 1 fraction/day 2. Radiotherapy dose: pGTV: 6360cGy/30F; pCTV1: 5460cGy/30F; pCTV2: 4920cGy/30F.
Conventional-dose Intensity-modulated radiotherapy
1. Definitive IMRT, 33 fractions, 5 fractions/week, 1 fraction/day 2. Radiotherapy dose: pGTV: 6996cGy/33F; pCTV1: 6006cGy/33F; pCTV2: 5412cGy/33F.
Cisplatin (100 mg/m2)
Cisplatin as concurrent chemotherapy, 100 mg/m2 day 1 per cycle, every 3 weeks for 2 cycles
Capecitabine
Metronomic adjuvant capecitabine chemotherapy: 650 mg/m2 p.o. bid, 1 year, adminstration starts immediately after concurrent chemoradiotherapy.
Locations (26)
Fujian Cancer Hospital
Fuzhou, Fujian, China
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China
Dongguan People's Hospital
Dongguan, Guangdong, China
The First People's Hospital of Foshan
Foshan, Guangdong, China
Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong, China
The Affiliated Panyu Central Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
Cancer Hospital of Shantou University Medical College
Shantou, Guangdong, China
Affiliated Hospital of Guangdong Medical University
Zhanjiang, Guangdong, China
Guangdong Nongken Central Hospital
Zhanjiang, Guangdong, China
Cancer Hospital of Guangxi Medical University
Nanning, Guangxi, China
Cancer Hospital of Guizhou Medical University
Guiyang, Guizhou, China
The Second Affiliated Hospital of Hainan Medical University
Haikou, Hainan, China
Hubei Province Cancer Hosiptal
Wuhan, Hubei, China
Tongji Hospital Affiliated with Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, China
Union Hospital Affiliated with Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, China
Hunan Cancer Hospital
Changsha, Hunan, China
Xiangya Hospital Central South University
Changsha, Hunan, China
Jiangsu Cancer Hospital
Nanjing, Jiangsu, China
Jiangsu Provinee Hospital of Chinese Medicine
Nanjing, Jiangsu, China
Jiangxi Cancer Center
Nanchang, Jiangxi, China
The First Affiliated Hospital of Xian Jiaotong University
Xian, Shanxi, China
Sichuan Cancer Hospital
Chengdu, Sichuan, China
West China Hospital,Sichuan University
Chengdu, Sichuan, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
Chongqing Cancer Hospital
Chongqing, China
Tianjin Medical University Cancer Institute & Hospital
Tianjin, China