The role of selective neck dissection in patients with early oral squamous cell carcinoma (1-3cm primary size) and no clinical evidence of lymph node metastases in the neck (N0)
- Conditions
- Topic: National Cancer Research NetworkSubtopic: Head and Neck CancerDisease: Head and NeckCancerOral squamous cell carcinoma
- Registration Number
- ISRCTN65018995
- Lead Sponsor
- Queen Mary University of London
- Brief Summary
2019 Results article in https://pubmed.ncbi.nlm.nih.gov/31611612/ results (added 12/06/2020)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 596
1. Patients with oral squamous cell carcinoma (OSCC) measuring 1 to 3 cm at the primary site (ICD9 codes: 141, 143, 144, 145, 146, 149)
2. No clinical or preoperative imaging evidence of nodal involvement in the neck (N0 neck)
3. Surgery is the primary mode of treatment
4. Age 16 years and over, either sex
5. Capable of giving written informed consent
1. Cancer of the lip (ICD9 code 140)
2. Previous head and neck tumour
3. Other synchronous tumour
4. Technical, medical or anaesthetic difficulties which preclude patients being entered into one of the trial arms
5. Where the surgeon assesses that the patient needs reconstruction that necessitates opening the neck
6. Those patients whom the multi-disciplinary team meeting considered to be medically, socially or psychiatrically unfit for surgery as first line treatment
7. Those patients where the patient expresses a preference for non-surgical treatment
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Overall survival
- Secondary Outcome Measures
Name Time Method <br> 1. Disease-free survival<br> 2. Local and regional recurrence<br> 3. Completeness of resection<br>