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
- 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
- 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.
Allocation: Randomized, Primary Purpose: Treatment
The Facial Surgery Research Foundation