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)
| ISRCTN | ISRCTN65018995 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN65018995 |
| ClinicalTrials.gov number | NCT00571883 |
| Secondary identifying numbers | 2069 |
- Submission date
- 23/04/2010
- Registration date
- 23/04/2010
- Last edited
- 25/10/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Cancer
Plain English Summary
Contact information
Scientific
Saving Faces
1st Floor Grove Building
Mile End Hospital
275 Bancroft Road
London
E1 4DG
United Kingdom
| Phone | +44 20 8223 8049 |
|---|---|
| send@savingfaces.co.uk |
Study information
| Study design | Randomised interventional treatment trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Treatment |
| Scientific title | 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) |
| Study acronym | SEND |
| Study hypothesis | 1. To determine whether the use of a selective neck dissection used electively (hereafter referred to as SEND) on all patients presenting with T1 and T2 tumours and no clinical evidence of neck metastasis (N0) improves survival, disease-free survival and loco-regional disease control rates 2. To determine how SEND and complex reconstruction affect quality of life (QoL) and mental health 3. To determine whether the use of SEND on all patients presenting with T1 and T2 tumours and clinically N0 necks represents a cost-effective use of resources |
| Ethics approval(s) | NRES Committee North East – Northern & Yorkshire, 11/11/2006, ref: 06/MRE03/69 |
| Condition | Topic: National Cancer Research Network; Subtopic: Head and Neck Cancer; Disease: Head and Neck |
| Intervention | The trial will be a two-arm randomized trial: Arm A: Patients will be allocated to have resection of the primary tumour with neck dissection Arm B: Patients will be allocated to have resection of the primary tumour only Follow up length: 96 months Study entry: single randomisation only |
| Intervention type | Other |
| Primary outcome measure | Overall survival |
| Secondary outcome measures | 1. Disease-free survival 2. Local and regional recurrence 3. Completeness of resection |
| Overall study start date | 03/01/2007 |
| Overall study end date | 31/07/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 16 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 652; UK Sample Size: 652 |
| Total final enrolment | 596 |
| Participant inclusion criteria | 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 |
| Participant exclusion criteria | 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 |
| Recruitment start date | 03/01/2007 |
| Recruitment end date | 27/07/2015 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
London
EC1A 7BE
United Kingdom
Sponsor information
University/education
Mile End Road
London
E1 4NS
England
United Kingdom
| Website | http://www.qmul.ac.uk/ |
|---|---|
"ROR" |
https://ror.org/026zzn846 |
Funders
Funder type
Charity
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- CR_UK, Cancer Research UK - London, CRUK
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 01/07/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | An initial paper was published in the British Journal of Cancer on the 15/10/2019 (the article is online with open-access and can be found at https://rdcu.be/bVfLH). Planned publication in a high-impact peer-reviewed journal with the results of the final analysis will be published around July 2026. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/11/2019 | 12/06/2020 | Yes | No |
| Plain English results | 25/10/2022 | No | Yes |
Editorial Notes
25/10/2022: Cancer Research UK plain English results link added.
12/08/2020: Publication and dissemination plan and IPD sharing statement added.
11/08/2020: The overall trial end date was changed from 31/07/2020 to 31/07/2025.
12/06/2020: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
07/04/2017: The overall trial end date has been updated from 30/04/2015 to 31/07/2020 and the recruitment end date has been updated from 30/04/2015 to 27/07/2015.
Note: The study was included in the NIHR portfolio in February 2006 and was registered in ISRCTN in April 2010. Awareness of the difference between inclusion in NIHR portfolio (step to get NHS support) and public registration (step to facilitate future publication) has evolved over time and may account for the delay regarding public registration. The study was registered before the recruitment of participants ended (in July 2015).
14/08/2013: The anticipated end date was updated from 01/05/2013 to 30/04/2015.
15/02/2011: The anticipated end date was updated from 01/01/2011 to 01/05/2013.
