Concurrent Chemoradiotherapy Alone Versus Induction Chemotherapy Plus Concurrent Chemoradiotherapy in Low-risk Locoregionally Advanced Nasopharyngeal Carcinoma: a Phase 3, Multicentre, Randomised Controlled Trial
Status: Recruiting
Location: See all (8) locations...
Intervention Type: Radiation, Drug
Study Type: Interventional
Study Phase: Phase 3
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).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:
• Age 18-70 years old.
• Patients with newly histologically confirmed non-keratinizing (according to WHO histologically type).
• Tumor staged as III-IVa except T4N2/AnyTN3 (according to the 8th AJCC edition) and pretreatment plasm EB Virus DNA\<4000copies/ml.
• Normal liver function test: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) \< 1.5×upper limit of normal (ULN) concomitant with alkaline phosphatase (ALP) \< 2.5×ULN, and bilirubin \< ULN.
• Patients must be informed of the investigational nature of this study and give written informed consent.
Locations
Other Locations
China
Hunan Cancer Hospital
NOT_YET_RECRUITING
Changsha
Guangzhou Panyu Central Hospital
NOT_YET_RECRUITING
Guangzhou
Sun Yat-sen University Cancer Center
RECRUITING
Guangzhou
Cancer Hospital of Guizhou Province
NOT_YET_RECRUITING
Guiyang
The First Affiliated Hospital of Guangxi Medical University
NOT_YET_RECRUITING
Nanning
Tongji Hospital,Tongji Medical College,Huazhong University of Science and Technology
NOT_YET_RECRUITING
Wuhan
Union Hospital, Tongji Medical College,Huazhong University of Science and Technology;
NOT_YET_RECRUITING
Wuhan
Zhongshan City People's Hospital
NOT_YET_RECRUITING
Zhongshan
Contact Information
Primary
Hai-Qiang Mai
maihq@sysucc.org.cn
862087343643
Time Frame
Start Date:2023-09-07
Estimated Completion Date:2029-09
Participants
Target number of participants:454
Treatments
Experimental: IMRT and concurrent cisplatin
Patients receive intensity modulated-radiotherapy (IMRT), concurrently with cisplatin 100 mg/m² every 3 weeks for 3 cycles.
Active_comparator: Induction chemotherapy+IMRT and concurrent cisplatin
Patients receive gemcitabine (1000 mg/m² d1,8) and cisplatin (80mg/m² d1) every 3 weeks for 3 cycles before radiotherapy, and then receive intensity modulated-radiotherapy (IMRT), concurrently with cisplatin 100 mg/m² every 3 weeks for 3 cycles.
Collaborators: Hunan Cancer Hospital, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Cancer Hospital of Guizhou Province, Tongji Hospital, Guangzhou Panyu Central Hospital, Zhongshan People's Hospital, Guangdong, China, First Affiliated Hospital of Guangxi Medical University