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Status unknownNCT00571883Updated Dec 14, 2015

Neck Surgery in Treating Patients With Early-Stage Oral Cancer

An interventional study of questionnaire administration and psychosocial assessment and care in Head and Neck Cancer, sponsored by The Facial Surgery Research Foundation. Status unknown at 27 sites in United Kingdom. Open to participants aged 16 Years to 120 Years. Per ClinicalTrials.gov, last updated 2015-12-14.

Sponsored by The Facial Surgery Research Foundation · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jul 2009), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
652
Allocation
Randomized
Ages
16 Years to 120 Years
Sex
All
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Study 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.

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.

02

Conditions studied

  • 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
03

In context

Head and Neck Neoplasms

2,344 studies on the registry are indexed under Head and Neck Neoplasms; 551 are open to participants now.

This study's planned enrollment of 652 is above the median of 47 across 1,751 interventional studies indexed under Head and Neck Neoplasms.

Browse Head and Neck Neoplasms studies →

Lead sponsor

This is the only study on the registry with The Facial Surgery Research Foundation as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years to 120 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility 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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Enrollment
652 participants (estimated)

Interventions

  • Otherquestionnaire administration
  • Procedurepsychosocial assessment and care
  • Procedurequality-of-life assessment
  • Procedureregional lymph node dissection
  • Proceduretherapeutic conventional surgery
06

What researchers measure

Primary outcomes

  1. Overall survival

Secondary outcomes

  1. Disease-free survival

  2. Local and regional recurrence

  3. Completeness of resection at the primary site

  4. Quality-of-life as measured by the EORTC QLQ-30 & H&N module

  5. Psychological well-being as measured by the Hospital Anxiety and Depression Scale (HADS) at 6, 12, and 24 months

  6. Costs to NHS, patients, and carers/families

  7. Incremental cost per life-year saved and/or per quality-adjusted life year (QALY)

07

Study locations

27 sites
  • 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
08

References and documents

Publications

  • 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. Erratum In: Br J Cancer. 2022 Mar;126(5):831. doi: 10.1038/s41416-021-01678-2. PubMed 31611612 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 14, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00571883
Lead sponsor
The Facial Surgery Research Foundation
First posted
Dec 12, 2007
Start date
Jan 2007
Primary completion
Dec 2015 (estimated)
Last update
Dec 14, 2015

Study contacts

Iain Hutchison
study chair · The Facial Surgery Research Foundation
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2009. You cannot join it, but the record below documents what was studied.

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