Overview
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.
Description
The main objective of the trial was to evaluate whether the 3-year failure-free survival (FFS) rate in patients with high-risk head and neck squamous cell carcinoma treated with adjuvant radiotherapy and 2 courses of concurrent cisplatin chemotherapy after surgery was no less than 10% compared with 3 courses of concurrent cisplatin chemotherapy. The secondary objective was to evaluate efficacy and toxicity of 2 courses of concurrent cisplatin chemotherapy (100mg/m2, days 1 and 22) during adjuvant intensity-modulated radiation therapy will be compared with 3 courses of concurrent cisplatin chemotherapy (100mg/m2, days 1, 22 and 43).
Eligibility
Inclusion Criteria:
- The pathological type is head and neck squamous cell carcinoma
- Stages III and IV
- 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
- No evidence of distant metastasis (M0).
- Functional status: Karnofsky scale (KPS) > 70.
- 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
- 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.
- Normal renal function: creatinine clearance > 60 ml/min.
- Patients must be informed of the basic contents of this study and sign informed consent.
Exclusion Criteria:
- Age >70 years or <18 years.
- Treatment is palliative.
- Previous chemotherapy (except induction chemotherapy prior to surgery).
- Previous radiation therapy.
- Women who are pregnant or breastfeeding
- Previous history of malignant tumor.
- 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.