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Neck Surgery in Treating Patients With Early-Stage Oral Cancer

Sponsor
The Facial Surgery Research Foundation (Other)
Overall Status
Unknown status
CT.gov ID
NCT00571883
Collaborator
(none)
652
Enrollment
27
Locations
24.1
Patients Per Site

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: questionnaire administration
  • Procedure: psychosocial assessment and care
  • Procedure: quality-of-life assessment
  • Procedure: regional lymph node dissection
  • Procedure: therapeutic conventional surgery
 N/A

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

Study Type:
Interventional
Anticipated Enrollment :
652 participants
Allocation:
Randomized
Primary Purpose:
Treatment
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
Study Start Date :
Jan 1, 2007
Anticipated Primary Completion Date :
Dec 1, 2015

Outcome Measures

Primary Outcome Measures

  1. Overall survival []

Secondary Outcome Measures

  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) []

Eligibility Criteria

Criteria

Ages Eligible for Study:
16 Years to 120 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust Birmingham England United Kingdom B15 2TH
2 Cumberland Infirmary Carlisle England United Kingdom CA2 7HY
3 Queen Alexandra Hospital Cosham England United Kingdom PO6 3LY
4 Derbyshire Royal Infirmary Derby England United Kingdom DE1 2QY
5 St. Luke's Cancer Centre at Royal Surrey County Hospital Guildford England United Kingdom GU2 7XX
6 Leicester Royal Infirmary Leicester England United Kingdom LE1 5WW
7 Lincoln County Hospital Lincoln England United Kingdom LN2 5QY
8 Aintree University Hospital Liverpool England United Kingdom L9 7AL
9 Facial Surgery Research Foundation London England United Kingdom EC1A 7BE
10 Saint Bartholomew's Hospital London England United Kingdom EC1A 7BE
11 St. George's Hospital London England United Kingdom SW17 0QT
12 University College of London Hospitals London England United Kingdom WIT 3AA
13 Luton and Dunstable Hospital Luton-Bedfordshire England United Kingdom LU4 0DZ
14 Wythenshawe Hospital Manchester England United Kingdom M23 9LJ
15 Freeman Hospital Newcastle-Upon-Tyne England United Kingdom NE7 7DN
16 Northampton General Hospital Northampton England United Kingdom NN1 5BD
17 Queen's Medical Centre Nottingham England United Kingdom NG7 2UH
18 Pennine Acute Hospitals Oldham England United Kingdom OL1 2PN
19 Queen's Hospital Romford England United Kingdom RM7 0AG
20 Sunderland Royal Hospital Sunderland England United Kingdom SR4 7TP
21 Torbay Hospital Torquay England United Kingdom TQ2 7AA
22 New Cross Hospital Wolverhampton England United Kingdom WV10 0QP
23 Falkirk and District Royal Infirmary Falkirk Scotland United Kingdom FK1 5QE
24 Southern General Hospital Glasgow Scotland United Kingdom G51 4TF
25 Crosshouse Hospital Kilmarnock Scotland United Kingdom KA2 OBE
26 University Hospital of Wales Cardiff Wales United Kingdom CF14 4XW
27 Barnet General Hospital Barnet, Hertfordshire United Kingdom EN5 3DJ

Sponsors and Collaborators

  • The Facial Surgery Research Foundation

Investigators

  • Study Chair: Iain Hutchison, The Facial Surgery Research Foundation

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00571883
Other Study ID Numbers:
  • CDR0000577728
  • FSRF-SEND-001
  • EU-20794
First Posted:
Dec 12, 2007
Last Update Posted:
Dec 14, 2015
Last Verified:
Jul 1, 2009
Keywords provided by , ,
stage I squamous cell carcinoma of the lip and oral cavity
stage II squamous cell carcinoma of the lip and oral cavity
tongue cancer
Additional relevant MeSH terms:
Head and Neck Neoplasms

Study Results

No Results Posted as of Dec 14, 2015