Neck Surgery in Treating Patients With Early-Stage Oral Cancer

Head and Neck Cancer Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00571883
• Other study ID #: CDR0000577728
• Secondary ID: FSRF-SEND-001EU-
• Status: Active, not recruiting
• Phase: N/A
• First received: December 11, 2007
• Last updated: December 11, 2015
• Start date: January 2007

Study information

• Verified date: July 2009
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Unspecified
• Study type: Interventional

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 652
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 120 Years

Eligibility

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 Design

Allocation: Randomized, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Squamous Cell
• Head and Neck Cancer
• Head and Neck Neoplasms

Intervention

Other:
• questionnaire administration

Procedure:
• psychosocial assessment and care

• quality-of-life assessment

• regional lymph node dissection

• therapeutic conventional surgery

Locations

Country	Name	City	State
United Kingdom	Barnet General Hospital	Barnet, Hertfordshire
United Kingdom	Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust	Birmingham	England
United Kingdom	University Hospital of Wales	Cardiff	Wales
United Kingdom	Cumberland Infirmary	Carlisle	England
United Kingdom	Queen Alexandra Hospital	Cosham	England
United Kingdom	Derbyshire Royal Infirmary	Derby	England
United Kingdom	Falkirk and District Royal Infirmary	Falkirk	Scotland
United Kingdom	Southern General Hospital	Glasgow	Scotland
United Kingdom	St. Luke's Cancer Centre at Royal Surrey County Hospital	Guildford	England
United Kingdom	Crosshouse Hospital	Kilmarnock	Scotland
United Kingdom	Leicester Royal Infirmary	Leicester	England
United Kingdom	Lincoln County Hospital	Lincoln	England
United Kingdom	Aintree University Hospital	Liverpool	England
United Kingdom	Facial Surgery Research Foundation	London	England
United Kingdom	Saint Bartholomew's Hospital	London	England
United Kingdom	St. George's Hospital	London	England
United Kingdom	University College of London Hospitals	London	England
United Kingdom	Luton and Dunstable Hospital	Luton-Bedfordshire	England
United Kingdom	Wythenshawe Hospital	Manchester	England
United Kingdom	Freeman Hospital	Newcastle-Upon-Tyne	England
United Kingdom	Northampton General Hospital	Northampton	England
United Kingdom	Queen's Medical Centre	Nottingham	England
United Kingdom	Pennine Acute Hospitals	Oldham	England
United Kingdom	Queen's Hospital	Romford	England
United Kingdom	Sunderland Royal Hospital	Sunderland	England
United Kingdom	Torbay Hospital	Torquay	England
United Kingdom	New Cross Hospital	Wolverhampton	England

Sponsors (1)

Lead Sponsor	Collaborator
The Facial Surgery Research Foundation

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival			No
Secondary	Disease-free survival			No
Secondary	Local and regional recurrence			No
Secondary	Completeness of resection at the primary site			No
Secondary	Quality-of-life as measured by the EORTC QLQ-30 & H&N module			No
Secondary	Psychological well-being as measured by the Hospital Anxiety and Depression Scale (HADS) at 6, 12, and 24 months			No
Secondary	Costs to NHS, patients, and carers/families			No
Secondary	Incremental cost per life-year saved and/or per quality-adjusted life year (QALY)			No