Spots Global Cancer Trial Database for Neck Surgery in Treating Patients With Early-Stage Oral Cancer

Study Description

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.

Keywords

Eligibility

Minimum Age: 16 Years

Eligible Ages: CHILD, ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Contact Details

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