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

Sun Yat-sen University

Status and phase: Not yet enrolling; Phase 3

Conditions: Squamous Cell Cancer of Head and Neck (SCCHN)

Treatments: Drug: Cisplatin

Study type: Interventional

Funder types: Other

Identifiers

NCT07125755

SL-B2025-367-02

Details and patient eligibility

About

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

Enrollment: 386 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

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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386 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: Cisplatin

Postoperative adjuvant radiotherapy alone

No Intervention 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)