Neck Surgery in Treating Patients With Early-Stage Oral Cancer

• Overall survival [ Designated as safety issue: No ]
  

• Disease-free survival [ Designated as safety issue: No ]
  
• Local and regional recurrence [ Designated as safety issue: No ]
  
• Completeness of resection at the primary site [ Designated as safety issue: No ]
  
• Quality-of-life as measured by the EORTC QLQ-30 & H&N module [ Designated as safety issue: No ]
  
• Psychological well-being as measured by the Hospital Anxiety and Depression Scale (HADS) at 6, 12, and 24 months [ Designated as safety issue: No ]
  
• Costs to NHS, patients, and carers/families [ Designated as safety issue: No ]
  
• Incremental cost per life-year saved and/or per quality-adjusted life year (QALY) [ Designated as safety issue: No ]
  

OBJECTIVES:

• To determine whether the use of a selective neck dissection (SEND) used electively on all patients presenting with stage I-II oral cavity squamous cell carcinoma (SCC) improves survival, disease-free survival, and loco-regional disease control rates.
• To determine how SEND and complex reconstruction affect quality of life and mental health.
• To determine whether the use of SEND on all patients presenting with stage I-II oral cavity SCC represents a cost-effective use of resources.

OUTLINE: This is a multicenter study. Patients are stratified by age (< 40 vs 40-64 vs ≥ 65 years of age), tumor stage (T1 vs T2), and surgeon.

• Arm I: Patients undergo resection of the primary tumor with neck dissection.
• Arm II: Patients undergo resection of the primary tumor alone. Patients complete the EORTC QLQ-C30, EORTC QLQ - H&N35, and the Hospital Anxiety and Depression Scale (HADS) before surgery and at 6, 12, and 24 months after surgery. Patients also complete the EQ-5D questionnaire at baseline, 6 months, 12 months, and 24 months. Additionally, a self-completion Health Service Use questionnaire is completed every 2 months, during the first 24 months after treatment, to enable costs to the NHS to be monitored.

After surgery, patients are followed periodically for up to 5 years.

Peer Reviewed and Funded or Endorsed by Cancer Research UK.