Condition category
Cancer
Date applied
23/04/2010
Date assigned
23/04/2010
Last edited
08/06/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Ms Fran Ridout

ORCID ID

Contact details

Saving Faces
1st Floor Grove Building
Mile End Hospital
275 Bancroft Road
London
E1 4DG
United Kingdom
+44 20 8223 8049
send@savingfaces.co.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00571883

Protocol/serial number

2069

Study information

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)

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

NRES Committee North East – Northern & Yorkshire, 11/11/2006, ref: 06/MRE03/69

Study design

Randomised interventional treatment trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

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

Phase

Phase IV

Drug names

Primary outcome measures

Overall survival

Secondary outcome measures

1. Disease-free survival
2. Local and regional recurrence
3. Completeness of resection

Overall trial start date

03/01/2007

Overall trial end date

31/07/2020

Reason abandoned

Eligibility

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 type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 652; UK Sample Size: 652

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

United Kingdom

Trial participating centre

St. Bartholomews Hospital
W Smithfield
London
EC1A 7BE
United Kingdom

Sponsor information

Organisation

Queen Mary University of London

Sponsor details

Mile End Road
London
E1 4NS
United Kingdom

Sponsor type

University/education

Website

http://www.qmul.ac.uk/

Funders

Funder type

Charity

Funder name

Cancer Research UK

Alternative name(s)

CRUK

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

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.