RecruitingPhase 3NCT06492460

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

A Multicenter, Randomized Controlled, Non-inferior Phase 3 Clinical Trial of 2 Courses of Concurrent Cisplatin Chemoradiotherapy Versus 3 Courses After Surgery for High-risk Head and Neck Squamous Cell Carcinoma

Sponsor

Sun Yat-sen University

Enrollment

422 participants

Start Date

Sep 20, 2024

Study Type

INTERVENTIONAL

Conditions

Squamous Cell Carcinoma of Head and Neck

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

Min Age: 18 YearsMax Age: 70 Years

Inclusion Criteria17

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 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.

Interventions

DRUGDrug：Cisplatin

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