Head and neck squamous cell carcinoma
Conditions
Interventions
Cervical radiation group:Patients in this group will receive adjuvant cervical radiation after neck dissection. The radiation mode is IMRT and the overall radiation dose should be 44-50Gy (2.0Gy/f) to
Cervical observation group:Patients in this group will not receive cervical radiation after neck dissection.
Sponsors
Sun Yat-Sen University Cancer Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Patients with head and neck squamous cell carcinoma who have received radical resection of primary lesions and neck dissection. The pathological stage of these patients should be pT1-3N1M0 (AJCC TNM staging system, eighth edition). The anatomic sites of primary lesions include oral cavity, oropharynx (HPV negative), larynx, and laryngopharynx. 2.Not receiving any other anti-tumor treatment except for the radical surgery. 3.No history of other malignancies. 4.Male or female, aged 18 to 75 years. 5.Adequate liver function: TBIL = 3.5 X 10^9/L; PLT >= 100 x 10^9/L; HGB >= 90g/L. 8. No severe dysfunction of major organs including heart and lung. 9. Performance status (PS) score <= 2. 10. Written informed consent.
Exclusion criteria
Exclusion criteria: 1. Women in pregnancy or lactation. 2. Patients who could not cooperate with regular follow-up due to any reasons. 3. Simultaneously receiving any experimental treatment of other clinical trials (in the treatment period of the clinical trial). 4. With severe and uncontrollable infectious or systematic diseases. 5. Long-term use of immunosuppressive agents after organ transplantation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 2-year regional recurrence-free survival (RRFS); | — |
Secondary
| Measure | Time frame |
|---|---|
| 5-year overall survival (OS);5-year distant metastasis-free survival (DMFS);5-year progression-free survival (PFS);Safety; | — |
Countries
China
Contacts
Public ContactMing Song
Sun Yat-Sen University Cancer Center
Outcome results
None listed