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Recruiting Phase 3

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

NCT06492460 · tracked via the Priya Life Science China tracker
Phase
Phase 3
Started
2024-09-20
Last updated
2025-08-14

Condition(s) studied

Squamous Cell Carcinoma of Head and Neck

Investigational drug(s) / intervention(s)

Drug:Cisplatin

Drug: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

Study 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

Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Failure-free survival (FFS) — 3 years
    calculated from enrolment to the date of locoregional recurrence,distant metastasis,or death from any cause, whichever occurred first.

Trial sites (5)

FacilityCityRegionStatus
Sun Yat-sen University Cancer Center Guangzhou Guangdong Recruiting
Affiliated Hospital of Guilin Medical College Guilin Guangxi Not Yet Recruiting
Hunan Cancer Hospital Changsha Hunan Not Yet Recruiting
Xiangya Hospital, Central South University Changsha Hunan Not Yet Recruiting
Jiangsu Cancer Hospital Nanjing Jiangsu Not Yet Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06492460 on ClinicalTrials.gov ↗ ← All trials in China