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Comparing Postoperative Adjuvant Cisplatin Concurrent Chemoradiotherapy With Adjuvant Radiotherapy Alone for Intermediate-risk Head and Neck Squamous Cell Carcinoma

RecruitingPhase 3Ages 18 Years - 70 YearsAllSun Yat-sen University
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In plain words

What the trial is, and whether it could suit you

The main objective of this trial was to determine the value of concurrent chemoradiotherapy for Intermediate-risk head and neck squamous cell carcinoma

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📋 Eligibility rules (as published)
Inclusion Criteria: A. The pathological type is head and neck squamous cell carcinoma * Stages B. Radical surgery has been performed, and there are intermediary-risk factors (pT3/pT4, pN2/pN3, positive lymph nodes in the cervical IV/V region of oral cancer, nerve invasion, and vascular invasion). 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. Previous chemotherapy (except induction chemotherapy prior to surgery). D. Previous radiation therapy. E. Women who are pregnant or breastfeeding F. Previous history of malignant tumor. G. With other serious medical conditions that may pose a greater risk or affect compliance with the test. Examples include: * unstable heart disease that requires treatment * kidney disease * chronic hepatitis * poorly controlled diabetes (fasting blood glucose \> 1.5×ULN) * mental illness.
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What it tests

  • Cisplatin
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Where

7 sites
Sun Yat-sen University Cancer Center
Guangzhou, China
Sun Yat-sen University Cancer Center
Guangzhou, China
Affiliated Hospital of Guilin Medical College
Guilin, China
Hainan General Hospital
Sanya, China
Hunan Cancer Hospital
Changsha, China
Xiangya Hospital, Central South University
Changsha, China
Jiangsu Cancer Hospital
Nanjing, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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