Neck Surgery in Treating Patients With Early-Stage Oral Cancer

Not Applicable

• Conditions: Head and Neck Cancer

• Registration Number: NCT00571883
• Lead Sponsor: The Facial Surgery Research Foundation

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.

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 Timeline

• Study Start: 2007-01
• Study First Submitted: 2007-12-11
• Study First Submitted QC: 2007-12-11
• Study First Posted: 2007-12-12
• Status Verified: 2009-07
• Primary Completion: 2015-12
• Last Update Submitted: 2015-12-11
• Last Update Posted: 2015-12-14

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 652

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall survival

Secondary Outcome Measures

Name	Time	Method
Completeness of resection at the primary site
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)
Local and regional recurrence
Quality-of-life as measured by the EORTC QLQ-30 & H&N module
Disease-free survival

Trial Locations

Locations (27)

Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust; 🇬🇧 Birmingham, England, United Kingdom

Cumberland Infirmary; 🇬🇧 Carlisle, England, United Kingdom

Queen Alexandra Hospital; 🇬🇧 Cosham, England, United Kingdom

Derbyshire Royal Infirmary; 🇬🇧 Derby, England, United Kingdom

St. Luke's Cancer Centre at Royal Surrey County Hospital; 🇬🇧 Guildford, England, 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

Scroll for more (17 remaining)