Neck Surgery in Treating Patients With Early-Stage Oral Cancer
Conditions
Head and Neck Cancer
Conditions: official terms
Carcinoma, Squamous Cell - Head and Neck Neoplasms
Conditions: Keywords
stage I squamous cell carcinoma of the lip and oral cavity, stage II squamous cell carcinoma of the lip and oral cavity, tongue cancer
Study Type
Interventional
Study Phase
N/A
Study Design
Allocation: Randomized, Primary Purpose: Treatment
Intervention
Name: questionnaire administration Type: Other
Name: psychosocial assessment and care Type: Procedure
Name: quality-of-life assessment Type: Procedure
Name: regional lymph node dissection Type: Procedure
Name: therapeutic conventional surgery Type: Procedure
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 16 Years
Gender: Both
Criteria: DISEASE CHARACTERISTICS:

- Patients with oral squamous cell carcinoma measuring 1 to 3 cm at the primary site

- No clinical or preoperative imaging evidence of nodal involvement in the neck (N0)

- Surgery is the primary mode of treatment

- Dose not need reconstruction that necessitates opening the neck, as assessed by the surgeon

- No cancer of the lip

- No prior head and neck tumor

PATIENT CHARACTERISTICS:

- No technical, medical, or anaesthetic difficulties that preclude patients being entered into one of the trial arms

- Not considered to be medically, socially, or psychiatrically unfit for surgery as first-line treatment by the multidisciplinary team

- No other synchronous tumor

- No preference for non-surgical treatment

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics
Locations
Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust
Birmingham, England, United Kingdom
Status: Recruiting
Contact: Contact Person - 44-121-414-5346
Cumberland Infirmary
Carlisle, England, United Kingdom
Status: Recruiting
Contact: Contact Person - 44-122-881-4222
Queen Alexandra Hospital
Cosham, England, United Kingdom
Status: Recruiting
Contact: Contact Person - 44-23-8079-5153
Derbyshire Royal Infirmary
Derby, England, United Kingdom
Status: Recruiting
Contact: Contact Person - 44-1332-347-141 ext. 24
St. Luke's Cancer Centre at Royal Surrey County Hospital
Guildford, England, United Kingdom
Status: Recruiting
Contact: Contact Person - 44-1483-571-122 ext. 44
Leicester Royal Infirmary
Leicester, England, United Kingdom
Status: Recruiting
Contact: Contact Person - 44-116-258-6318
Lincoln County Hospital
Lincoln, England, United Kingdom
Status: Recruiting
Contact: Contact Person - 44-1522-573-202
Aintree University Hospital
Liverpool, England, United Kingdom
Status: Recruiting
Contact: Contact Person - 44-151-334-1155
Facial Surgery Research Foundation
London, England, United Kingdom
Status: Recruiting
Contact: Iain Hutchison - 44-207-601-7582
Saint Bartholomew's Hospital
London, England, United Kingdom
Status: Recruiting
Contact: Contact Person - 44-207-601-7582 - send@savingfaces.info
St. George's Hospital
London, England, United Kingdom
Status: Recruiting
Contact: Contact Person - 44-208-661-3049 ext. 3
University College of London Hospitals
London, England, United Kingdom
Status: Recruiting
Contact: Contact Person - 44-207-679-9895
Luton and Dunstable Hospital
Luton-Bedfordshire, England, United Kingdom
Status: Recruiting
Contact: Contact Person - 44-158-249-7333
Wythenshawe Hospital
Manchester, England, United Kingdom
Status: Recruiting
Contact: Contact Person - 44-161-237-2538
Freeman Hospital
Newcastle-Upon-Tyne, England, United Kingdom
Status: Recruiting
Contact: Contact Person - 44-191-291-9432
Northampton General Hospital
Northampton, England, United Kingdom
Status: Recruiting
Contact: Contact Person - 44-160-454-4579
Queen's Medical Centre
Nottingham, England, United Kingdom
Status: Recruiting
Contact: Contact Person - 44-115-924-9924 ext. 68915
Pennine Acute Hospitals
Oldham, England, United Kingdom
Status: Recruiting
Contact: Contact Person - 44-161-720-2143
Queen's Hospital
Romford, England, United Kingdom
Status: Recruiting
Contact: Contact Person - 44-207-601-8815
Sunderland Royal Hospital
Sunderland, England, United Kingdom
Status: Recruiting
Contact: Contact Person - 44-191-569-9132
Torbay Hospital
Torquay, England, United Kingdom
Status: Recruiting
Contact: Contact Person - 44-180-365-4834
New Cross Hospital
Wolverhampton, England, United Kingdom
Status: Recruiting
Contact: Contact Person - 44-1902-694-430
Falkirk and District Royal Infirmary
Falkirk, Scotland, United Kingdom
Status: Recruiting
Contact: Contact Person - 44-132-461-6419
Southern General Hospital
Glasgow, Scotland, United Kingdom
Status: Recruiting
Contact: Contact Person - 44-141-201-1100
Crosshouse Hospital
Kilmarnock, Scotland, United Kingdom
Status: Recruiting
Contact: Contact Person - 44-156-357-7488
University Hospital of Wales
Cardiff, Wales, United Kingdom
Status: Recruiting
Contact: Contact Person - 44-2920-196-193
Barnet General Hospital
Barnet, Hertfordshire, United Kingdom
Status: Recruiting
Contact: Contact Person - 44-208-375-2098
Start Date
January 2007
Sponsors
The Facial Surgery Research Foundation
Source
National Cancer Institute (NCI)
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page