2 Courses of Concurrent Cisplatin Chemoradiotherapy After Surgery for High-risk Head and Neck Squamous Cell Carcinoma
Recruiting now · Phase 3
Conditions studied: Squamous Cell Carcinoma of Head and Neck
In brief
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.
Key facts
- Study ID
- NCT06492460
- Run by
- Sun Yat-sen University
- People needed
- 422
- Starts
- 2024-09-20
- Expected to finish
- 2033-07-17
- Last updated by the study team
- 2025-08-14
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Sun Yat-sen University Cancer Center — Guangzhou, Guangdong, China (enrolling)
- Affiliated Hospital of Guilin Medical College — Guilin, Guangxi, China
- Hunan Cancer Hospital — Changsha, Hunan, China
- Xiangya Hospital, Central South University — Changsha, Hunan, China
- Jiangsu Cancer Hospital — Nanjing, Jiangsu, China
Full record on ClinicalTrials.gov
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