Neck Surgery in Treating Patients With Early-Stage Oral Cancer
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
3 other identifiers
interventional
652
1 country
27
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable head-and-neck-cancer
27 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2007
CompletedFirst Submitted
Initial submission to the registry
December 11, 2007
CompletedFirst Posted
Study publicly available on registry
December 12, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedDecember 14, 2015
July 1, 2009
8.9 years
December 11, 2007
December 11, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall survival
Secondary Outcomes (7)
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
- +2 more secondary outcomes
Interventions
Eligibility Criteria
Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.
Sponsors & Collaborators
Study Sites (27)
Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust
Birmingham, England, B15 2TH, United Kingdom
Cumberland Infirmary
Carlisle, England, CA2 7HY, United Kingdom
Queen Alexandra Hospital
Cosham, England, PO6 3LY, United Kingdom
Derbyshire Royal Infirmary
Derby, England, DE1 2QY, United Kingdom
St. Luke's Cancer Centre at Royal Surrey County Hospital
Guildford, England, GU2 7XX, United Kingdom
Leicester Royal Infirmary
Leicester, England, LE1 5WW, United Kingdom
Lincoln County Hospital
Lincoln, England, LN2 5QY, United Kingdom
Aintree University Hospital
Liverpool, England, L9 7AL, United Kingdom
Facial Surgery Research Foundation
London, England, EC1A 7BE, United Kingdom
Saint Bartholomew's Hospital
London, England, EC1A 7BE, United Kingdom
St. George's Hospital
London, England, SW17 0QT, United Kingdom
University College of London Hospitals
London, England, WIT 3AA, United Kingdom
Luton and Dunstable Hospital
Luton-Bedfordshire, England, LU4 0DZ, United Kingdom
Wythenshawe Hospital
Manchester, England, M23 9LJ, United Kingdom
Freeman Hospital
Newcastle upon Tyne, England, NE7 7DN, United Kingdom
Northampton General Hospital
Northampton, England, NN1 5BD, United Kingdom
Queen's Medical Centre
Nottingham, England, NG7 2UH, United Kingdom
Pennine Acute Hospitals
Oldham, England, OL1 2PN, United Kingdom
Queen's Hospital
Romford, England, RM7 0AG, United Kingdom
Sunderland Royal Hospital
Sunderland, England, SR4 7TP, United Kingdom
Torbay Hospital
Torquay, England, TQ2 7AA, United Kingdom
New Cross Hospital
Wolverhampton, England, WV10 0QP, United Kingdom
Falkirk and District Royal Infirmary
Falkirk, Scotland, FK1 5QE, United Kingdom
Southern General Hospital
Glasgow, Scotland, G51 4TF, United Kingdom
Crosshouse Hospital
Kilmarnock, Scotland, KA2 OBE, United Kingdom
University Hospital of Wales
Cardiff, Wales, CF14 4XW, United Kingdom
Barnet General Hospital
Barnet, Hertfordshire, EN5 3DJ, United Kingdom
Related Publications (2)
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.
PMID: 37650478DERIVEDHutchison 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.
PMID: 31611612DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Iain Hutchison
The Facial Surgery Research Foundation
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
December 11, 2007
First Posted
December 12, 2007
Study Start
January 1, 2007
Primary Completion
December 1, 2015
Last Updated
December 14, 2015
Record last verified: 2009-07