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Recruiting Phase 3 NCT06492460

2 Courses of Concurrent Cisplatin Chemoradiotherapy After Surgery for High-risk Head and Neck Squamous Cell Carcinoma

Trial Parameters

Condition Squamous Cell Carcinoma of Head and Neck
Sponsor Sun Yat-sen University
Study Type INTERVENTIONAL
Phase Phase 3
Enrollment 422
Sex ALL
Min Age 18 Years
Max Age 70 Years
Start Date 2024-09-20
Completion 2029-09-20
Interventions
Drug:Cisplatin

Brief Summary

The main objective of this trial was to determine the value of 2 courses of cisplatin concurrent chemotherapy in postoperative adjuvant radiotherapy for high-risk head and neck squamous cell carcinoma.

Eligibility Criteria

Inclusion Criteria: A. The pathological type is head and neck squamous cell carcinoma * Stages III and IV B. Radical surgery has been performed with high risk factors (one of below) * extracapsular invasion of cervical metastatic lymph nodes * positive incisional margin or inadequate incisional margin safety distance C. No evidence of distant metastasis (M0). D. Functional status: Karnofsky scale (KPS) \> 70. E. Normal bone marrow function: * white blood cell count \> 4×109/L * hemoglobin \> 120g/L in males, 110g/L in females * platelet count \> 100×109/L G. Normal liver function: * alanine aminotransferase (ALT), aspartate aminotransferase (AST) \< 1.5 times the upper limit of normal (ULN) * alkaline phosphatase (ALP) \< 2.5×ULN * bilirubin \< ULN. H. Normal renal function: creatinine clearance \> 60 ml/min. I. Patients must be informed of the basic contents of this study and sign informed consent. Exclusion Criteria: A. Age \>70 years or \<18 years. B. Treatment is palliative. C. Pre

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