Cisplatin chemotherapy with radiotherapy for high-risk head and neck cancer after surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This trial evaluates the effectiveness of two courses of cisplatin chemotherapy given concurrently with adjuvant radiotherapy in patients who have undergone surgery for high-risk head and neck squamous cell carcinoma. The primary goal is to determine if the three-year failure-free survival rate is at least 10% better with this regimen compared to three courses of chemotherapy. The study also assesses the efficacy and toxicity of the two-course regimen compared to the three-course regimen during intensity-modulated radiation therapy.

Why it matters

Who can join: the full rules

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.

Where it's running

• Sun Yat-sen University Cancer Center
  Guangzhou, Guangdong, China Recruiting
• Affiliated Hospital of Guilin Medical College
  Guilin, Guangxi, China Not yet recruiting
• Hunan Cancer Hospital
  Changsha, Hunan, China Not yet recruiting
• Xiangya Hospital, Central South University
  Changsha, Hunan, China Not yet recruiting
• Jiangsu Cancer Hospital
  Nanjing, Jiangsu, China Not yet recruiting

Study contacts

• Principal investigator: Lei Chen, M.D — Sun Yat-sen University
• Study coordinator: Lei Chen, M.D
• Email: chenlei@sysucc.org.cn
• Phone: +862013570051477

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.