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

• Status: Unknown status
• Trial end date: 2018-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jiangsu Cancer Institute & Hospital
• Collaborators: Affiliated Hospital of Jiangnan University; Changzhou Cancer Hospital; Changzhou Cancer Hospital of Soochow University; Nanjing BenQ Hospital; Nanjing Cancer Hospital; Northern Jiangsu Province People's Hospital; The First Affiliated Hospital with Nanjing Medical University; The Second Hospital of Nanjing Medical University; Wuxi Cancer Hospital
• Treatments: Cisplatin; Fluorouracil; Raltitrexed

Criteria

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