Postoperative cisplatin with radiation versus radiation alone for intermediate‑risk head and neck squamous cell carcinoma

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 Phase 3 interventional trial compares postoperative adjuvant concurrent cisplatin chemoradiotherapy with adjuvant radiotherapy alone in patients who have had radical surgery for intermediate‑risk head and neck squamous cell carcinoma. Eligible patients have intermediate‑risk pathological features (for example pT3/pT4, pN2/pN3, certain cervical IV/V nodal involvement for oral cancer, perineural or vascular invasion), no distant metastasis, and adequate organ function and performance status. Participants receive standard postoperative radiotherapy either alone or together with concurrent cisplatin, and outcomes include recurrence, survival, and treatment tolerability. The trial was conducted at Sun Yat‑sen University Cancer Center and an affiliated hospital in China.

Why it matters

Who can join: the full rules

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.

Where it's running

• Sun Yat-sen University Cancer Center
  Guangzhou, Guangdong, China Recruiting
• Sun Yat-sen University Cancer Center
  Guangzhou, Guangdong, China Recruiting
• Affiliated Hospital of Guilin Medical College
  Guilin, Guangxi, China Recruiting
• Hainan General Hospital
  Sanya, Hainan, China Recruiting
• Hunan Cancer Hospital
  Changsha, Hunan, China Recruiting
• Xiangya Hospital, Central South University
  Changsha, Hunan, China Recruiting

Study contacts

• Principal investigator: Lei Chen Principal Investigator, 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.