Induction Chemotherapy Followed by Concurrent Radiation With Cetuximab or Cisplatin in Locally Advanced Nasopharyngeal Cancer

• Status: Unknown status
• Trial end date: 2014-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to compare the efficacy and toxicity of docetaxel-cisplatin neoadjuvant chemotherapy followed by concurrent radiotherapy with cetuximab or weekly cisplatin in locally advanced nasopharyngeal carcinoma.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fudan University
• Treatments: Cetuximab; Cisplatin; Docetaxel

Criteria

Inclusion Criteria:

1. Histopathologically proven nasopharyngeal carcinoma (WHO type 2 or 3)

2. Stage Ⅲ-ⅣB disease (AJCC/UICC 2009)

3. ECOG performance status of 0-1

4. Life expectancy of more than 6 months

5. Signed written informed consent

6. Adequate organ function including the following:

• Absolute neutrophil count (ANC) >= 1.5 * 109/l

• Platelets count >= 100 * 109/l

• Hemoglobin >= 10 g/dl

• AST and ALT <= 2.5 times institutional upper limit of normal (ULN)

• Total bilirubin <= 1.5 times institutional ULN

• Creatinine clearance >= 50 ml/min

• Serum creatine <= 1 times ULN

Exclusion Criteria:

1. Evidence of distant metastasis

2. Prior chemotherapy or anti-cancer biologic therapy for any type of cancer, or prior radiotherapy to the head and neck region

3. Other previous or concomitant cancer, except for in situ cervical cancer and cutaneous basal cell carcinoma

4. Pregnant or breast-feeding females, or females and males of childbearing potential not taking adequate contraceptive measures

5. Presence of an uncontrolled concomitant illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia