Head and Neck CancerNCT00571883
Neck Surgery in Treating Patients With Early-Stage Oral Cancer
A study testing questionnaire administration, psychosocial assessment and care and quality-of-life assessment in people with Head and Neck Cancer, run by The Facial Surgery Research Foundation at 27 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 120 years
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- questionnaire administration, psychosocial assessment and care and quality-of-life assessment
- Type of treatment
- Surgery or procedure
- How many people
- 652 participants
- Where
- 27 sitesUnited Kingdom
- Study dates
- Jan 2007to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 120 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Trial locations and contacts
27 sites in 1 country.
27 sites in 1 country
United Kingdom27 sites
Barnet General Hospital
Barnet, Hertfordshire, EN5 3DJ
Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust
Birmingham, England, B15 2TH
University Hospital of Wales
Cardiff, Wales, CF14 4XW
Cumberland Infirmary
Carlisle, England, CA2 7HY
Queen Alexandra Hospital
Cosham, England, PO6 3LY
Derbyshire Royal Infirmary
Derby, England, DE1 2QY
Falkirk and District Royal Infirmary
Falkirk, Scotland, FK1 5QE
Southern General Hospital
Glasgow, Scotland, G51 4TF
St. Luke's Cancer Centre at Royal Surrey County Hospital
Guildford, England, GU2 7XX
Crosshouse Hospital
Kilmarnock, Scotland, KA2 OBE
Leicester Royal Infirmary
Leicester, England, LE1 5WW
Lincoln County Hospital
Lincoln, England, LN2 5QY
Aintree University Hospital
Liverpool, England, L9 7AL
Facial Surgery Research Foundation
London, England, EC1A 7BE
Saint Bartholomew's Hospital
London, England, EC1A 7BE
St. George's Hospital
London, England, SW17 0QT
University College of London Hospitals
London, England, WIT 3AA
Luton and Dunstable Hospital
Luton-Bedfordshire, England, LU4 0DZ
Wythenshawe Hospital
Manchester, England, M23 9LJ
Freeman Hospital
Newcastle upon Tyne, England, NE7 7DN
Northampton General Hospital
Northampton, England, NN1 5BD
Queen's Medical Centre
Nottingham, England, NG7 2UH
Pennine Acute Hospitals
Oldham, England, OL1 2PN
Queen's Hospital
Romford, England, RM7 0AG
Sunderland Royal Hospital
Sunderland, England, SR4 7TP
Torbay Hospital
Torquay, England, TQ2 7AA
New Cross Hospital
Wolverhampton, England, WV10 0QP
About this study
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
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.
Read the 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.
- Conditions
- Head and Neck Cancer
- Being tested
- questionnaire administration, psychosocial assessment and care, quality-of-life assessment, regional lymph node dissection, therapeutic conventional surgery
- 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
- Medical subject headings
- Head and Neck Neoplasms, Tongue Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnaire administrationOther
psychosocial assessment and careProcedure or surgery
quality-of-life assessmentProcedure or surgery
regional lymph node dissectionProcedure or surgery
therapeutic conventional surgeryProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Costs to NHS, patients, and carers/families
Incremental cost per life-year saved and/or per quality-adjusted life year (QALY)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2007 (estimated)
- Study startJan 2007
- Primary completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Enrolment
- 652 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Facial Surgery Research Foundation
- Sponsor type
- University, hospital or other
- Investigators
- Iain Hutchison, Study chair, The Facial Surgery Research Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00571883
- Sponsor's protocol ID
- CDR0000577728
- Other IDs
- FSRF-SEND-001, EU-20794
- Status last verified
- Jul 2009
- First submitted
- 11 Dec 2007
- Last updated
- 14 Dec 2015
- Results posted
- No
Publications
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.
PubMed 37650478Hutchison 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.
PubMed 31611612
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00571883
- Acronym / sponsor ID
- CDR0000577728
- Conditions
- Head and Neck Cancer
- 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
- Recruitment status
- Unknown status
- Enrolment
- 652 participants (estimated)
- Lead sponsor
- The Facial Surgery Research FoundationUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- Dec 2015 (estimated)
- First posted
- 12 Dec 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
Who may qualify
- Ages
- 16 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| questionnaire administration | Other | – |
| psychosocial assessment and care | Procedure or surgery | – |
| quality-of-life assessment | Procedure or surgery | – |
| regional lymph node dissection | Procedure or surgery | – |
| therapeutic conventional surgery | Procedure or surgery | – |
Primary outcome
Overall survival
7 secondary outcomes
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2015.
- Derived from this study: PubMed 37650478Worthington 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.
- Derived from this study: PubMed 31611612Hutchison 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Iain Hutchison study chair
The Facial Surgery Research Foundation
27 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing questionnaire administration, psychosocial assessment and care and quality-of-life assessment in people with Head and Neck Cancer, run by The Facial Surgery Research Foundation at 27 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00571883, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2015.