Neck Surgery in Treating Patients With Early-Stage Oral Cancer
RATIONALE: Surgery may be an effective treatment for oral cancer. It is not yet known whether surgery to remove the tumor and lymph nodes in the neck is more effective than surgery to remove the tumor alone in treating patients with early-stage oral cancer.
PURPOSE: This randomized clinical trial is comparing two types of neck surgery to see how well they work in treating patients with early stage oral cancer.
Head and Neck Cancer
Other: questionnaire administration
Procedure: psychosocial assessment and care
Procedure: quality-of-life assessment
Procedure: regional lymph node dissection
Procedure: therapeutic conventional surgery
|Study Design:||Allocation: Randomized
Primary Purpose: Treatment
|Official Title:||SEND Trial The Role of Selective Neck Dissection Used Electively in Patients With Early Oral Squamous Cell Carcinoma (1-3cm Primary Size) and No Clinical Evidence of Lymph Node Metastases in the Neck|
- Overall survival
- Disease-free survival
- Local and regional recurrence
- Completeness of resection at the primary site
- Quality-of-life as measured by the EORTC QLQ-30 & H&N module
- Psychological well-being as measured by the Hospital Anxiety and Depression Scale (HADS) at 6, 12, and 24 months
- Costs to NHS, patients, and carers/families
- Incremental cost per life-year saved and/or per quality-adjusted life year (QALY)
|Study Start Date:||January 2007|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00571883
|Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust|
|Birmingham, England, United Kingdom, B15 2TH|
|Carlisle, England, United Kingdom, CA2 7HY|
|Queen Alexandra Hospital|
|Cosham, England, United Kingdom, PO6 3LY|
|Derbyshire Royal Infirmary|
|Derby, England, United Kingdom, DE1 2QY|
|St. Luke's Cancer Centre at Royal Surrey County Hospital|
|Guildford, England, United Kingdom, GU2 7XX|
|Leicester Royal Infirmary|
|Leicester, England, United Kingdom, LE1 5WW|
|Lincoln County Hospital|
|Lincoln, England, United Kingdom, LN2 5QY|
|Aintree University Hospital|
|Liverpool, England, United Kingdom, L9 7AL|
|Facial Surgery Research Foundation|
|London, England, United Kingdom, EC1A 7BE|
|Saint Bartholomew's Hospital|
|London, England, United Kingdom, EC1A 7BE|
|St. George's Hospital|
|London, England, United Kingdom, SW17 0QT|
|University College of London Hospitals|
|London, England, United Kingdom, WIT 3AA|
|Luton and Dunstable Hospital|
|Luton-Bedfordshire, England, United Kingdom, LU4 0DZ|
|Manchester, England, United Kingdom, M23 9LJ|
|Newcastle-Upon-Tyne, England, United Kingdom, NE7 7DN|
|Northampton General Hospital|
|Northampton, England, United Kingdom, NN1 5BD|
|Queen's Medical Centre|
|Nottingham, England, United Kingdom, NG7 2UH|
|Pennine Acute Hospitals|
|Oldham, England, United Kingdom, OL1 2PN|
|Romford, England, United Kingdom, RM7 0AG|
|Sunderland Royal Hospital|
|Sunderland, England, United Kingdom, SR4 7TP|
|Torquay, England, United Kingdom, TQ2 7AA|
|New Cross Hospital|
|Wolverhampton, England, United Kingdom, WV10 0QP|
|Falkirk and District Royal Infirmary|
|Falkirk, Scotland, United Kingdom, FK1 5QE|
|Southern General Hospital|
|Glasgow, Scotland, United Kingdom, G51 4TF|
|Kilmarnock, Scotland, United Kingdom, KA2 OBE|
|University Hospital of Wales|
|Cardiff, Wales, United Kingdom, CF14 4XW|
|Barnet General Hospital|
|Barnet, Hertfordshire, United Kingdom, EN5 3DJ|
|Study Chair:||Iain Hutchison||The Facial Surgery Research Foundation|