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Neck Surgery in Treating Patients With Early-Stage Oral Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00571883
First received: December 11, 2007
Last updated: December 11, 2015
Last verified: July 2009
  Purpose

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 Intervention
Head and Neck Cancer
Other: questionnaire administration
Procedure: psychosocial assessment and care
Procedure: quality-of-life assessment
Procedure: regional lymph node dissection
Procedure: therapeutic conventional surgery

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Overall survival [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Disease-free survival [ Designated as safety issue: No ]
  • Local and regional recurrence [ Designated as safety issue: No ]
  • Completeness of resection at the primary site [ Designated as safety issue: No ]
  • Quality-of-life as measured by the EORTC QLQ-30 & H&N module [ Designated as safety issue: No ]
  • Psychological well-being as measured by the Hospital Anxiety and Depression Scale (HADS) at 6, 12, and 24 months [ Designated as safety issue: No ]
  • Costs to NHS, patients, and carers/families [ Designated as safety issue: No ]
  • Incremental cost per life-year saved and/or per quality-adjusted life year (QALY) [ Designated as safety issue: No ]

Estimated Enrollment: 652
Study Start Date: January 2007
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   16 Years to 120 Years   (Child, Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00571883

Locations
United Kingdom
Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust
Birmingham, England, United Kingdom, B15 2TH
Cumberland Infirmary
Carlisle, England, United Kingdom, CA2 7HY
Queen Alexandra Hospital
Cosham, England, United Kingdom, PO6 3LY
Derbyshire Royal Infirmary
Derby, England, United Kingdom, DE1 2QY
St. Luke's Cancer Centre at Royal Surrey County Hospital
Guildford, England, United Kingdom, GU2 7XX
Leicester Royal Infirmary
Leicester, England, United Kingdom, LE1 5WW
Lincoln County Hospital
Lincoln, England, United Kingdom, LN2 5QY
Aintree University Hospital
Liverpool, England, United Kingdom, L9 7AL
Facial Surgery Research Foundation
London, England, United Kingdom, EC1A 7BE
Saint Bartholomew's Hospital
London, England, United Kingdom, EC1A 7BE
St. George's Hospital
London, England, United Kingdom, SW17 0QT
University College of London Hospitals
London, England, United Kingdom, WIT 3AA
Luton and Dunstable Hospital
Luton-Bedfordshire, England, United Kingdom, LU4 0DZ
Wythenshawe Hospital
Manchester, England, United Kingdom, M23 9LJ
Freeman Hospital
Newcastle-Upon-Tyne, England, United Kingdom, NE7 7DN
Northampton General Hospital
Northampton, England, United Kingdom, NN1 5BD
Queen's Medical Centre
Nottingham, England, United Kingdom, NG7 2UH
Pennine Acute Hospitals
Oldham, England, United Kingdom, OL1 2PN
Queen's Hospital
Romford, England, United Kingdom, RM7 0AG
Sunderland Royal Hospital
Sunderland, England, United Kingdom, SR4 7TP
Torbay Hospital
Torquay, England, United Kingdom, TQ2 7AA
New Cross Hospital
Wolverhampton, England, United Kingdom, WV10 0QP
Falkirk and District Royal Infirmary
Falkirk, Scotland, United Kingdom, FK1 5QE
Southern General Hospital
Glasgow, Scotland, United Kingdom, G51 4TF
Crosshouse Hospital
Kilmarnock, Scotland, United Kingdom, KA2 OBE
University Hospital of Wales
Cardiff, Wales, United Kingdom, CF14 4XW
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
  More Information

ClinicalTrials.gov Identifier: NCT00571883     History of Changes
Other Study ID Numbers: CDR0000577728  FSRF-SEND-001  EU-20794 
Study First Received: December 11, 2007
Last Updated: December 11, 2015
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
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:
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Neoplasms by Site

ClinicalTrials.gov processed this record on September 26, 2016