Concurrent Nimotuzumab Versus Cisplatin With Radiotherapy for Locoregionally Advanced NPC

Phase Ⅲ Study of Neoadjuvant TPF Chemotherapy Followed by Radiotherapy With Concurrent Nimotuzumab or Cisplatin for Locoregionally Advanced Nasopharyngeal Carcinoma (NPC).

The study is to evaluate whether concurrent nimotuzumab could decrease the severe acute treatment-related toxicities compared with concurrent chemoradiotherapy for locoregionally advanced NPC. Three hundreds and twenty patients will be recruited into this study.

Scheme:

Eligible stage III and IVA/B NPC patients will first be stratified by institution, then randomized to 2 arms at 1:1 ratio.

- Arm Cisplatin:

Neoadjuvant TPF chemotherapy (docetaxel 75 mg/m2, cisplatin 75 mg/m2, 5-FU 2500 mg/m2 every 3 weeks for 3 cycles), followed by cisplatin 40 mg/m2/week in concurrent with IMRT

- Arm nimotuzumab:

Neoadjuvant TPF chemotherapy (docetaxel 75 mg/m2, cisplatin 75 mg/m2, 5-FU 2500 mg/m2 every 3 weeks for 3 cycles), followed by weekly nimotuzumab 200mg in concurrent with IMRT

Inclusion Criteria:

• Histologically proven poorly differentiated or undifferentiated carcinoma of the nasopharynx.
• Stage III and IVA/B NPC patients
• KPS >70
• Age between 18-70
• AGC > 2000, platelets > 100,000, AST or ALT<2 x upper normal, serum creatinine<1.5mg/dl, creatinine clearance >50ml/min

Exclusion Criteria:

• Histology other than poorly differentiated or undifferentiated carcinoma, including keratinized squamous cell carcinoma.
• Evidence of metastases (below the clavicle or distant) by clinical or radiographic examinations.
• Initial surgical treatment excluding diagnostic biopsy of the primary site or neck disease.
• Patients with simultaneous or prior malignancy (not include basal cell carcinoma of skin)
• Prior radiation treatment to the head and neck or any prior chemotherapy