Neck Surgery in Treating Patients With Early-Stage Oral Cancer
- Conditions
- Head and Neck Cancer
- Registration Number
- NCT00571883
- Lead Sponsor
- The Facial Surgery Research Foundation
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 652
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Overall survival
- Secondary Outcome Measures
Name Time Method Completeness of resection at the primary site 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) Local and regional recurrence Quality-of-life as measured by the EORTC QLQ-30 & H&N module Disease-free survival
Trial Locations
- Locations (27)
Barnet General Hospital
🇬🇧Barnet, Hertfordshire, United Kingdom
St. George's Hospital
🇬🇧London, England, United Kingdom
Cumberland Infirmary
🇬🇧Carlisle, England, United Kingdom
Queen Alexandra Hospital
🇬🇧Cosham, England, United Kingdom
Derbyshire Royal Infirmary
🇬🇧Derby, England, United Kingdom
Leicester Royal Infirmary
🇬🇧Leicester, England, United Kingdom
Freeman Hospital
🇬🇧Newcastle-Upon-Tyne, England, United Kingdom
St. Luke's Cancer Centre at Royal Surrey County Hospital
🇬🇧Guildford, England, United Kingdom
Wythenshawe Hospital
🇬🇧Manchester, England, United Kingdom
Aintree University Hospital
🇬🇧Liverpool, England, United Kingdom
Luton and Dunstable Hospital
🇬🇧Luton-Bedfordshire, England, United Kingdom
Facial Surgery Research Foundation
🇬🇧London, England, United Kingdom
Northampton General Hospital
🇬🇧Northampton, England, United Kingdom
Lincoln County Hospital
🇬🇧Lincoln, England, United Kingdom
Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust
🇬🇧Birmingham, England, United Kingdom
Saint Bartholomew's Hospital
🇬🇧London, England, United Kingdom
Queen's Medical Centre
🇬🇧Nottingham, England, United Kingdom
University College of London Hospitals
🇬🇧London, England, United Kingdom
New Cross Hospital
🇬🇧Wolverhampton, England, United Kingdom
Southern General Hospital
🇬🇧Glasgow, Scotland, United Kingdom
Torbay Hospital
🇬🇧Torquay, England, United Kingdom
Crosshouse Hospital
🇬🇧Kilmarnock, Scotland, United Kingdom
Pennine Acute Hospitals
🇬🇧Oldham, England, United Kingdom
Queen's Hospital
🇬🇧Romford, England, United Kingdom
Sunderland Royal Hospital
🇬🇧Sunderland, England, United Kingdom
Falkirk and District Royal Infirmary
🇬🇧Falkirk, Scotland, United Kingdom
University Hospital of Wales
🇬🇧Cardiff, Wales, United Kingdom