Concurrent and Adjuvant Nimotuzumab Combined With Induction Chemotherapy Plus Chemoradiation in Nasopharyngeal Carcinoma
Nasopharyngeal Carcinoma by AJCC V8 Stage
About this trial
This is an interventional treatment trial for Nasopharyngeal Carcinoma by AJCC V8 Stage focused on measuring Nimotuzumab, Nasopharyngeal Carcinoma, Induction Chemotherapy, Chemoradiation, Adjuvant Therapy
Eligibility Criteria
Inclusion Criteria: Age: 18 to 70. Pathological type: non-keratinizing carcinoma (World Health Organization criteria). Diagnosed with LANPC (stage III-IV, except for patients with T3N0)) according to the 8th edition clinical staging system of the American Joint Committee on Cancer [AJCC]/Union for International Cancer Control [UICC]. ECOG performance score: 0 to 1. Primary lesions can measurable. Adequate marrow function: neutrocyte count≥1.5×10e9/L, hemoglobin ≥90g/L and platelet count ≥100×10e9/L. Alanine Aminotransferase (ALT)/Aspartate Aminotransferase (AST) ≤2.5×upper limit of normal (ULN), and creatinine clearance rate ≥ 50 ml/min (Cockcroft-Gault formula). Patients must sign informed consent and be willing and able to comply with the requirements of visits, treatment, laboratory tests and other research requirements stipulated in the research schedule. Exclusion Criteria: Primary lesions or lymph node have been operated (except of operation for biopsy). Previous Received other anti EGFR monoclonal antibody treatment;Previous chemotherapy or immunization therapy. Other malignant tumor. Participation in other interventional clinical trials within 1 month. History of Serious lung or heart disease. Pregnant or breast-feeding women and women who refused to take contraceptive method. Drug abuse or alcohol addiction. History of serious allergic or allergy. Refused or can't signed informed consent form. Other patients who are considered ineligible for the study by the investigator.
Sites / Locations
- People's Hospital of BaiseRecruiting
- Affiliated Hospital of Youjiang Medical University for NationalitiesRecruiting
- Guilin Medical University, ChinaRecruiting
- Nanxishan Hospital of Guangxi Zhuang Autonomous RegionRecruiting
- the Fourth Affiliated Hospital of Guangxi Medical UniversityRecruiting
- Second Affiliated Hospital of Guangzhou Medical UniversityRecruiting
- The First People's Hospital of QinzhouRecruiting
- Wuzhou Red Cross HospitalRecruiting
- Liuzhou People's HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Experimental: Nimotuzumab arm
Control
Patients will receive induction chemotherapy with nimotuzumab (200mg/w,weekly plus gemcitabine (1g/m2, d1 & 8 of every cycle) and cisplatin (80mg/m2, d1 of every cycle), every 3 weeks for 2 cycles before radiation. Definitive intensity-modulated radiotherapy (IMRT) will be given. Concurrent nimotuzumab (200mg/w,weekly, 6-7 weeks) and cisplatin (100mg/m2,every 3 weeks for 3cycles )will be administered during IMRT. After 4-6 weeks of the completion of IMRT, adjuvant nimotuzumab (200mg ) will be given every 3 weeks for 8 cycles.
Patients will receive induction chemotherapy with gemcitabine (1g/m2, d1 & 8 of every cycle) and cisplatin (80mg/m2, d1 of every cycle), every 3 weeks for 2 cycles before radiation. Definitive intensity-modulated radiotherapy (IMRT) will be given. Concurrent nimotuzumab (200mg/w,weekly, 6-7 weeks) and cisplatin (100mg/m2,every 3 weeks for 3cycles )will be administered during IMRT.