Neck Surgery in Treating Patients With Early-Stage Oral Cancer

The Facial Surgery Research Foundation

Status: Unknown

Conditions: Head and Neck Cancer

Treatments: Procedure: therapeutic conventional surgery; Procedure: quality-of-life assessment; Other: questionnaire administration; Procedure: psychosocial assessment and care; Procedure: regional lymph node dissection

Study type: Interventional

Funder types: Other

Identifiers

NCT00571883

FSRF-SEND-001

EU-20794

CDR0000577728

Details and patient eligibility

About

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.

Full 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.

Enrollment: 652 estimated patients

Sex: All

Ages: 16 to 120 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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