Cisplatin Plus Raltitrexed or 5-fluorouracil Concurrent With Radiotherapy for Head and Neck Squamous Cell Cancer

A Multicenter Phase Ⅲ Trial of Cisplatin Plus Raltitrexed or 5-fluorouracil in Concurrence With Intensity-modulated Radiotherapy (IMRT) for the Treatment of Locoregionally Advanced Head and Neck Squamous Cell Cancer

This study is a multicenter phase Ⅲ trial. The objective is to compare the efficacy and toxicity of cisplatin plus raltitrexed or 5-fluorouracil in concurrence with IMRT for patients with locoregionally advanced head and neck squamous cell cancer.

The objective is to compare the efficacy and toxicity of cisplatin plus raltitrexed or 5-fluorouracil in concurrence with IMRT for patients with locoregionally advanced head and neck squamous cell cancer.

Inclusion Criteria:

• Pathologically confirmed untreated head and neck squamous cell cancer patients
• 18-70 years
• Clinical stage: T3-4N0-3M0 or T1-4N1-3M0
• Hematologic function: WBC ≥ 4.0×109/L, PLT ≥ 80×109/L, Hb ≥ 10mg/dL
• Renal function: Cr ≤ 1.25×UNL
• Hepatic function: BIL ≤ 1.5×UNL, ALT/AST ≤ 2.5×UNL
• ECOG ≤ 1
• Woman and man of childbearing age must adopt contraception
• With written consent

Exclusion Criteria:

• Malignant history
• Pregnant or lactating women
• With other severe diseases (blood, liver ,kidney or heart diseases)
• Subjects not suitable for chemo-radiotherapy
• Without written consent