This trial is active, not recruiting.

Condition head and neck cancer
Treatments questionnaire administration, psychosocial assessment and care, quality-of-life assessment, regional lymph node dissection, therapeutic conventional surgery
Sponsor The Facial Surgery Research Foundation
Start date January 2007
End date December 2015
Trial size 652 participants
Trial identifier NCT00571883, CDR0000577728, EU-20794, FSRF-SEND-001


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Primary purpose treatment

Primary Outcomes

Overall survival
time frame:

Secondary Outcomes

Disease-free survival
time frame:
Local and regional recurrence
time frame:
Completeness of resection at the primary site
time frame:
Quality-of-life as measured by the EORTC QLQ-30 & H&N module
time frame:
Psychological well-being as measured by the Hospital Anxiety and Depression Scale (HADS) at 6, 12, and 24 months
time frame:
Costs to NHS, patients, and carers/families
time frame:
Incremental cost per life-year saved and/or per quality-adjusted life year (QALY)
time frame:

Eligibility Criteria

Male or female participants from 16 years up to 120 years old.

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

Additional Information

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
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.
Trial information was received from ClinicalTrials.gov and was last updated in December 2015.
Information provided to ClinicalTrials.gov by National Cancer Institute (NCI).