Neck Surgery in Treating Patients With Early-Stage Oral Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Head and Neck Cancer

Intervention / Treatment
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* Other: questionnaire administration
* Procedure: psychosocial assessment and care
* Procedure: quality-of-life assessment
* Procedure: regional lymph node dissection
* Procedure: therapeutic conventional surgery


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized


Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: questionnaire administration|nan|
|Procedure: psychosocial assessment and care|nan|
|Procedure: quality-of-life assessment|nan|
|Procedure: regional lymph node dissection|nan|
|Procedure: therapeutic conventional surgery|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage I squamous cell carcinoma of the lip and oral cavity, stage II squamous cell carcinoma of the lip and oral cavity, tongue cancer