Comparing Postoperative Adjuvant Cisplatin Concurrent Chemoradiotherapy With Adjuvant Radiotherapy Alone for Intermediate-risk Head and Neck Squamous Cell Carcinoma
A Prospective, Multicenter, Randomized Controlled Phase 3 Clinical Trial Comparing Postoperative Adjuvant Cisplatin Concurrent Chemoradiotherapy With Adjuvant Radiotherapy Alone for Intermediate-risk Head and Neck Squamous Cell Carcinoma
Sun Yat-sen University
386 participants
Aug 15, 2025
INTERVENTIONAL
Conditions
Summary
The main objective of this trial was to determine the value of concurrent chemoradiotherapy for Intermediate-risk head and neck squamous cell carcinoma
Eligibility
Inclusion Criteria15
- 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 Criteria12
- 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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Interventions
Concurrent Cisplatin chemotherapy (100 mg/m2 intravenous injection,once every 3 weeks, twice in total, on days 1 and 22) will be given plus intensity modulated radiotherapy
Locations(7)
View Full Details on ClinicalTrials.gov
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NCT07125755