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RECRUITING
NCT06239727
PHASE3

Reduced-dose Radiotherapy for Stage III Nasopharyngeal Carcinoma Based on the Treatment Response

Sponsor: Sun Yat-sen University

View on ClinicalTrials.gov

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

Interventions

DRUG

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.

DRUG

Gemcitabine

Gemcitabine as induction chemotherapy, 1000 mg/m2 day 1, 8 per cycle, every 3 weeks for 3 cycles.

DRUG

Cisplatin (80 mg/m2)

Cisplatin as induction chemotherapy, 80 mg/m2 day 1 per cycle, every 3 weeks for 3 cycles.

RADIATION

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.

RADIATION

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.

DRUG

Cisplatin (100 mg/m2)

Cisplatin as concurrent chemotherapy, 100 mg/m2 day 1 per cycle, every 3 weeks for 2 cycles

DRUG

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