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RECRUITING
NCT05979961
PHASE3

Phase III Trial of Concurrent Chemotherapy Alone in Patients With Low-risk Nasopharyngeal Carcinoma

Sponsor: Sun Yat-sen University

View on ClinicalTrials.gov

Summary

The purpose of this study is to compare concurrent chemoradiotherapy (CCRT) alone with induction chemotherapy (gemcitabine+cisplatin) plus CCRT in patients with low-risk locoregionally advanced nasopharyngeal carcinoma(NPC).

Official title: Concurrent Chemoradiotherapy Alone Versus Induction Chemotherapy Plus Concurrent Chemoradiotherapy in Low-risk Locoregionally Advanced Nasopharyngeal Carcinoma: a Phase 3, Multicentre, Randomised Controlled Trial

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

454

Start Date

2023-09-07

Completion Date

2029-09

Last Updated

2024-08-06

Healthy Volunteers

No

Interventions

RADIATION

IMRT and concurrent cisplatin

Patients receive concurrent cisplatin 100mg/m2 every 21days for three cycles during Intensity modulated radiotherapy (IMRT)

DRUG

gemcitabine and cisplatin (Induction chemotherapy)

Patients receive gemcitabine (1000 mg/m² d1,8) and cisplatin (80mg/m² d1) every 3 weeks for 3 cycles before radiotherapy

Locations (8)

Guangzhou Panyu Central Hospital

Guangzhou, Guangdong, China

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Zhongshan City People's Hospital

Zhongshan, Guangdong, China

The First Affiliated Hospital of Guangxi Medical University

Nanning, Guangxi, China

Cancer Hospital of Guizhou Province

Guiyang, Guizhou, China

Tongji Hospital,Tongji Medical College,Huazhong University of Science and Technology

Wuhan, Hubei, China

Union Hospital, Tongji Medical College,Huazhong University of Science and Technology;

Wuhan, Hubei, China

Hunan Cancer Hospital

Changsha, Hunan, China