Neck Surgery in Treating Patients With Early-Stage Oral Cancer
NCT ID: NCT00571883
Last Updated: 2015-12-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
652 participants
INTERVENTIONAL
2007-01-31
Brief Summary
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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
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* 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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
TREATMENT
Interventions
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questionnaire administration
psychosocial assessment and care
quality-of-life assessment
regional lymph node dissection
therapeutic conventional surgery
Eligibility Criteria
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Inclusion Criteria
* 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
16 Years
120 Years
ALL
No
Sponsors
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The Facial Surgery Research Foundation
OTHER
Principal Investigators
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Iain Hutchison
Role: STUDY_CHAIR
The Facial Surgery Research Foundation
Locations
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Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust
Birmingham, England, United Kingdom
Cumberland Infirmary
Carlisle, England, United Kingdom
Queen Alexandra Hospital
Cosham, England, United Kingdom
Derbyshire Royal Infirmary
Derby, England, United Kingdom
St. Luke's Cancer Centre at Royal Surrey County Hospital
Guildford, England, United Kingdom
Leicester Royal Infirmary
Leicester, England, United Kingdom
Lincoln County Hospital
Lincoln, England, United Kingdom
Aintree University Hospital
Liverpool, England, United Kingdom
Facial Surgery Research Foundation
London, England, United Kingdom
Saint Bartholomew's Hospital
London, England, United Kingdom
St. George's Hospital
London, England, United Kingdom
University College of London Hospitals
London, England, United Kingdom
Luton and Dunstable Hospital
Luton-Bedfordshire, England, United Kingdom
Wythenshawe Hospital
Manchester, England, United Kingdom
Freeman Hospital
Newcastle upon Tyne, England, United Kingdom
Northampton General Hospital
Northampton, England, United Kingdom
Queen's Medical Centre
Nottingham, England, United Kingdom
Pennine Acute Hospitals
Oldham, England, United Kingdom
Queen's Hospital
Romford, England, United Kingdom
Sunderland Royal Hospital
Sunderland, England, United Kingdom
Torbay Hospital
Torquay, England, United Kingdom
New Cross Hospital
Wolverhampton, England, United Kingdom
Falkirk and District Royal Infirmary
Falkirk, Scotland, United Kingdom
Southern General Hospital
Glasgow, Scotland, United Kingdom
Crosshouse Hospital
Kilmarnock, Scotland, United Kingdom
University Hospital of Wales
Cardiff, Wales, United Kingdom
Barnet General Hospital
Barnet, Hertfordshire, , United Kingdom
Countries
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References
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Worthington HV, Bulsara VM, Glenny AM, Clarkson JE, Conway DI, Macluskey M. Interventions for the treatment of oral cavity and oropharyngeal cancers: surgical treatment. Cochrane Database Syst Rev. 2023 Aug 31;8(8):CD006205. doi: 10.1002/14651858.CD006205.pub5.
Hutchison IL, Ridout F, Cheung SMY, Shah N, Hardee P, Surwald C, Thiruchelvam J, Cheng L, Mellor TK, Brennan PA, Baldwin AJ, Shaw RJ, Halfpenny W, Danford M, Whitley S, Smith G, Bailey MW, Woodwards B, Patel M, McManners J, Chan CH, Burns A, Praveen P, Camilleri AC, Avery C, Putnam G, Jones K, Webster K, Smith WP, Edge C, McVicar I, Grew N, Hislop S, Kalavrezos N, Martin IC, Hackshaw A. Nationwide randomised trial evaluating elective neck dissection for early stage oral cancer (SEND study) with meta-analysis and concurrent real-world cohort. Br J Cancer. 2019 Nov;121(10):827-836. doi: 10.1038/s41416-019-0587-2. Epub 2019 Oct 15.
Other Identifiers
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FSRF-SEND-001
Identifier Type: -
Identifier Source: secondary_id
EU-20794
Identifier Type: -
Identifier Source: secondary_id
CDR0000577728
Identifier Type: -
Identifier Source: org_study_id