Study of Chemoradiotherapy Combined With Cetuximab in Nasopharyngeal Carcinoma

• Status: Completed
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This is an open, multicenter phase Ⅱ clinical trial. The purpose of this study is to evaluate acute toxicity and efficacy of cetuximab (C225) combined with IMRT + neoadjuvant chemotherapy in advanced T stage of nasopharyngeal carcinoma. Besides, to figure out the relationship between patient outcome and EGFR gene copy number, expression and mutation.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Sun Yat-sen University
• Collaborators: Affiliated Cancer Hospital of Shantou University Medical College; Cancer Hospital of Shantou University; First People's Hospital of Foshan; Hubei Cancer Hospital; Hunan Cancer Hospital; Jiangxi Provincial Cancer Hospital; Shenzhen People's Hospital; The First Affiliate Hospital of Guangxi Medical College; Tongji University; Wenzhou Medical University; Wuhan Union Hospital, China; Wuhan University; Xijing Hospital; Zhejiang Cancer Hospital
• Treatments: Cetuximab

Criteria

Inclusion Criteria:

• Histologic diagnosis of nasopharyngeal carcinoma

• Range from 18～69 years old

• T3-4，N0-2，M0 (AJCC 2009)

• KPS ≥ 80

• Nonmetastatic diseases

• WBC count ≥ 4×109/L，Hemoglobin ≥ 100g/L， platelet count ≥ 100×109/L

• ALT or AST < 1.5×ULN、bilirubin < 1.5×ULN

• 0Serum creatinine < 1.5×ULN

Exclusion Criteria:

• Distance metastases

• Previously treated (surgery，chemotherapy, radiation therapy，EGFR targeted therapy or immunotherapy)

• Second malignancy within 5 years

• Precious therapy with an investigational agent

• Uncontrolled seizure disorder or other serious neurologic disease

• ≥ Grade Ш allergic reaction to any drug including in this study

• Clinically significant cardiac or respiratory disease

• Creatinine clearance < 30ml/min

• Drug or alcohol addition

• Do not have full capacity for civil acts

• Severe complication, active infection

• Concurrent immunotherapy or hormone therapy for other diseases

• Pregnancy or lactation