Neck Surgery in Treating Patients With Early-Stage Oral Cancer

December 11, 2015 updated by: The Facial Surgery Research Foundation

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

652

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 120 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Overall survival

Secondary Outcome Measures

Outcome Measure
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Facial Surgery Research Foundation

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Primary Completion (Anticipated)

December 1, 2015

Study Registration Dates

First Submitted

December 11, 2007

First Submitted That Met QC Criteria

December 11, 2007

First Posted (Estimate)

December 12, 2007

Study Record Updates

Last Update Posted (Estimate)

December 14, 2015

Last Update Submitted That Met QC Criteria

December 11, 2015

Last Verified

July 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000577728
  • FSRF-SEND-001
  • EU-20794

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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