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

Sun Yat-sen University

Status and phase: Enrolling; Phase 3

Conditions: Squamous Cell Carcinoma of Head and Neck

Treatments: Drug: Drug：Cisplatin

Study type: Interventional

Funder types: Other

Identifiers

NCT06492460

SL-B2024-323-02

Details and patient eligibility

About

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.

Full 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).

Enrollment: 422 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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. 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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422 participants in 2 patient groups

2 courses of cisplatin chemoradiotherapy arm

Experimental group

Description:

Patients will receive intensity modulated radiotherapy (total dose: \> 66 Gy, split dose: 2-2.2 Gy/ time, once a day, 5 times a week) plus concurrent Cisplatin chemotherapy (100 mg/m2 intravenous injection,once every 3 weeks, twice in total, on days 1 and 22).

Treatment:

Drug: Drug：Cisplatin

3 courses of cisplatin chemoradiotherapy arm

Experimental group

Description:

Patients will receive intensity modulated radiotherapy (total dose: \> 66 Gy, split dose: 2-2.2 Gy/ time, once a day, 5 times a week) plus concurrent Cisplatin chemotherapy (100 mg/m2 intravenous injection,once every 3 weeks, once every 3 weeks, 3 times in total, days 1, 22, and 43).

Treatment:

Drug: Drug：Cisplatin