Status:
RECRUITING
2 Courses of Concurrent Cisplatin Chemoradiotherapy After Surgery for High-risk Head and Neck Squamous Cell Carcinoma
Lead Sponsor:
Sun Yat-sen University
Collaborating Sponsors:
Hunan Cancer Hospital
Guilin Medical University, China
Conditions:
Squamous Cell Carcinoma of Head and Neck
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief 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...
Detailed 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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 20 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 17 2033
Estimated Enrollment :
422 Patients enrolled
Trial Details
Trial ID
NCT06492460
Start Date
September 20 2024
End Date
July 17 2033
Last Update
August 14 2025
Active Locations (5)
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1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060
2
Affiliated Hospital of Guilin Medical College
Guilin, Guangxi, China
3
Hunan Cancer Hospital
Changsha, Hunan, China
4
Xiangya Hospital, Central South University
Changsha, Hunan, China