SEND

Title  The role of selective neck dissection used electively in patients with early oral squamous cell carcinoma (tumour stage T1 and T2) and no clinical evidence of lymph node metastases in the neck
Acronym  SEND
Study Type Prospective Randomised Controlled Trial
Status  In follow-up
Funding  Cancer Research UK, Saving Faces – The Facial Surgery Research Foundation
Ethics NRES Committee North East – Northern & Yorkshire (ref: 06/MRE03/69)

UPDATE 27/07/15: This trial is now closed to recruitment. We will be publishing the results in the near future. Please check back soon or contact us for more information.

Background

For patients with early stage oral cancer, surgery to remove the tumour is the first line and usually the only required form of treatment. Radiotherapy or chemotherapy can sometimes be given after surgery but this is only the case if the tumour is at a more advanced stage. Like many other forms of cancer, oral cancer can spread and the most common site that oral cancer spreads to is the lymph glands in the neck. Even where scans and clinical assessments show that there is no evidence of cancer in the lymph glands, there is still about a 30% chance that there will be some microscopic cancer in these glands that cannot be detected. When treating early stage oral cancer when no disease has been detected in the neck, surgeons will remove the mouth tumour and may also decide to take a pre-emptive approach and remove the lymph glands at the same time to stop the cancer spreading. Some surgeons will routinely remove the lymph glands at this stage while others may choose to actively monitor the disease and only remove the lymph glands if disease becomes apparent. Both approaches are standard procedures carried out by surgeons every day but depend on the individual surgeon which treatment they will offer their patient. As with any surgery there are risks involved with both approaches and these always need to be balanced not only against the chance of curing the disease but also against the benefits and effects on the patient’s quality of life. However, the fact is that there is no real evidence that one approach is clearly better for the patient than the other.

Aims

The SEND trial aims to answer the question of which is the better approach when treating patients with this early stage oral cancer. Patients will have either one of the two treatment options, as they would if they were not in the trial and then followed up closely to monitor their progress. There are no new or untried procedures in this trial. It simply compares two standard forms of treatment to decide which approach is better for treating patients with this disease.

Interventions

652 patients will be randomised to one of two trial arms: Arm 1: Patients will be allocated to have resection of the primary tumour with neck dissection Arm 2: Patients will be allocated to have resection of the primary tumour only Patients will be asked to complete QoL questionnaires at specific time-points during their study follow up. Patients will also be asked if they wish to donate blood and tissue samples at the time of surgery.

Outcomes

The primary outcome is overall survival and the secondary outcomes are disease-free survival, local and regional recurrence, completeness of resection, adverse effects, quality of life, emotional and psychological measures and financial costs.

Aims

  1. To determine whether the use of a selective neck dissection used electively (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).
  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.

Inclusion criteria

  1. Patients with T1 or T2 oral SCC at the primary site
  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
  5. Capable of giving written informed consent

Exclusion criteria

  1. Cancer of the lip
  2. Previous oral or pharyngeal SCC
  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.

Sub-studies

NON SEND – Follow up study for patients who are approached for SEND but do not wish to be randomised and want to choose their treatment.

SEND NR – Follow up study for patients who are not considered to be suitable for entry into a randomised trial.

Chief Investigator
Professor Iain Hutchison, Chief Executive, Saving Faces – The Facial Surgery Research Foundation and Consultant in Oral and Maxillofacial Surgery, St. Bartholomew’s Hospital, London

Clinical Research Manager
Fran Ridout, Saving Faces – The Facial Surgery Research Foundation

Trial Coordinator
Sharon Cheung, Saving Faces – The Facial Surgery Research Foundation

For further information, please contact Sharon Cheung.
Email: send@savingfaces.co.uk

Cancer Research UK