Head and Neck Cancer
Conditions
Keywords
stage I squamous cell carcinoma of the lip and oral cavity, stage II squamous cell carcinoma of the lip and oral cavity, tongue cancer
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.
Interventions
OTHERquestionnaire administration
PROCEDUREpsychosocial assessment and care
PROCEDUREquality-of-life assessment
PROCEDUREregional lymph node dissection
PROCEDUREtherapeutic conventional surgery
Sponsors
The Facial Surgery Research Foundation
Study design
Allocation
RANDOMIZED
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
16 Years to 120 Years
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Local and regional recurrence | — |
| Completeness of resection at the primary site | — |
| Quality-of-life as measured by the EORTC QLQ-30 & H&N module | — |
| Disease-free survival | — |
| Costs to NHS, patients, and carers/families | — |
| Incremental cost per life-year saved and/or per quality-adjusted life year (QALY) | — |
| Psychological well-being as measured by the Hospital Anxiety and Depression Scale (HADS) at 6, 12, and 24 months | — |
Countries
United Kingdom
Outcome results
None listed