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40.2Gy Versus 49.2Gy Radiotherapy in Low-Risk Target Volume for Chemosensitive Stage II Nasopharyngeal Carcinoma
Sponsor: Ming-Yuan Chen
Summary
This study aims to explore the efficacy and adverse events of reduced-dose radiotherapy (40.2Gy) versus conventional-dose radiotherapy (49.2Gy) to low-risk target volume for chemosensitive intermediate-stage nasopharyngeal carcinoma patients.
Official title: 40.2Gy Versus 49.2Gy Radiotherapy in Low-Risk Target Volume for Chemosensitive Stage II Nasopharyngeal Carcinoma Under Full-Course Immunotherapy: a Multicentre, Randomised, Phase 3 Trial
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
346
Start Date
2025-11-20
Completion Date
2032-06-30
Last Updated
2026-01-09
Healthy Volunteers
No
Conditions
Interventions
Cisplatin-based induction chemotherapy
Gemcitabine + cisplatin: Gemcitabine, 1,000 mg/m², Q3W, d1+d8, IV drip; cisplatin, 80 mg/m², Q3W, d1-3, IV drip. A total of 3 cycles. (Note: Gemcitabine can be replaced by docetaxel, albumin-bound paclitaxel, paclitaxel, etc.)
Full course of PD-1 monoclonal antibody
Tislelizumab 200 mg , once every 3 weeks (Q3W), intravenous infusion (iv). A total of 12 courses of treatment will be administered, including 3 courses during the induction chemotherapy phase, 3 courses during the radiotherapy phase, and 6 courses during the post-radiotherapy maintenance phase. Administration will start on Day 1 of induction chemotherapy and continue after the end of radiotherapy until the occurrence of intolerable toxicities, disease progression, withdrawal of consent, determination by the investigator that the patient needs to withdraw from treatment, or the completion of 12 courses, whichever comes first.
Reduced-dose radiotherapy to CTV2
GTV, 63.6Gy/30Fr/2.12Gy; CTV1, 54Gy/30Fr/1.8Gy; CTV2, 40.2Gy/30F/1.34Gy
Conventional-dose radiotherapy to CTV2
GTV, 63.6Gy/30Fr/2.12Gy; CTV1, 54Gy/30Fr/1.8Gy; CTV2, 49.2Gy/30Fr/1.64Gy
Locations (15)
Anhui Provincial Cancer Hospital
Hefei, Anhui, China
Fujian Cancer Hospital
Fuzhou, Fujian, China
Sun Yat-sen University cancer center
Guangzhou, Guangdong, China
the Affiliated Cancer Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
Cancer Hospital of Shantou University Medical College
Shantou, Guangdong, China
Zhongshan City People's Hospital
Zhongshan, Guangdong, China
The Fifth Affiliated Hospital of Sun Yat-sen University
Zhuhai, Guangdong, China
Guangxi Medical University Cancer Hospital
Nanning, Guangxi, China
Wuzhou Red Cross Hospital
Wuzhou, Guangxi, China
Central South University Cancer Hospital,
Changsha, Hunan, China
Xiangya Hospital of Central South University
Changsha, Hunan, China
West China Hospital, Sichuan University
Chengdu, Sichuan, China
The First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, China
Yunnan Cancer Hospital
Kunming, Yunnan, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China