"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”
A trial looking at two surgical treatments for early mouth cancer (SEND-001)
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This trial is comparing two standard surgical treatments for mouth cancer, to see if one approach has a better outcome. This trial is supported by Cancer Research UK.
Mouth cancer can sometimes
If surgeons do find secondaries in your neck, you will have some of the lymph glands removed from the affected side of your neck. This is called ‘selective neck dissection’ or ‘SEND’. But surgeons can’t always tell who has hidden secondaries. So they can either perform a SEND when your mouth cancer is removed, just in case. Or they can just remove your mouth cancer and operate again in the future if secondaries develop. Surgeons want to find out if one of these approaches is better than the other.
The aims of this trial are to find out
- If having SEND when the mouth cancer is removed (rather than waiting) prolongs the life of people with mouth cancer
- How surgery affects how you feel about and cope with your mouth cancer and treatment
Who can enter
You can enter this trial if you
- Have a mouth cancer (oral squamous cell carcinoma or 'SCC') which is smaller than 4cm (stages T1 or T2 mouth cancer) at the original ('primary') site
- Do not have any evidence of cancer spreading to your neck (‘neck secondaries’) from examinations or scans
- Are due to have surgery as the first treatment for your mouth cancer
- Are 16 years or older
You cannot enter this trial if you
- Have already had a mouth cancer (‘oral squamous cell carcinoma or ‘SCC’) or a cancer of the
'squamous cells'of the throat (pharynx)
- Have another type of cancer as well as your current mouth cancer
- Have cancer of the lip
- Will need an operation on your neck to rebuild (reconstruct) the area where you had your cancer
- Are likely to have difficulties with the
- Have any medical condition that means you cannot have surgery as part of this trial
This trial will recruit 652 patients with mouth cancer. There are two treatment groups and it is randomised. The people taking part are put into treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in.
Everyone in the trial will have surgery to remove the cancer in their mouth.
If you are in group 1 you will also have SEND surgery. Your surgeon will remove the lymph glands from your neck at the same time as removing the cancer in your mouth.
If you are in group 2 you will not have SEND unless you develop neck secondaries in the future.
Whichever group you are in, you may also have the area where your cancer was removed rebuilt. This is called ‘reconstruction’, and may use skin or tissue taken from somewhere else on your body (‘skin graft’). All the treatments and procedures in this study are normal practice. You would have reconstruction whether or not you were taking part in this trial.
Before you have your surgery you will see the surgeon and have some tests. These tests include
You will also be asked to fill out some questionnaires before your surgery and then at 6, 12 and 24 months after your surgery. The questionnaires will ask you about any side effects you have had and about how you have been feeling. These are called quality of life studies.
If you are in group 1, you will need to stay in hospital for several days (3-5) after your surgery. If you are in group 2, you will stay in for fewer days (1-3).
Whichever group you are in, you will see your surgeon regularly for 5 years after your surgery. This would be the same if you were not on the trial. You will see your surgeon
- Once a month for the first year
- Once every 2 months for the 2nd year
- Once every 3-4 months for the years after that
At some of these hospital visits a member of the research team will meet you. They will ask you questions about your health, symptoms and how you are feeling about your health.
Your surgeon may ask you to attend occasional clinics during the 6th, 7th and 8th years after your treatment.
You will not have any extra side effects as a result of taking part in this trial. Both procedures in this trial are standard treatments for head and neck cancer. Whichever group you are in, the side effects will be the same as any other type of surgery, and may include
- A risk of losing blood
- A possible reaction to the medicine you have while you are in hospital
- Discomfort in the area you had your surgery
- Feeling tired and weak
- Swelling of your face - this usually gets better after a few weeks
- Difficulties with talking, chewing and swallowing
If you are in the group having selective neck surgery to your lymph nodes (SEND), you will have a scar on your neck. But this scar will fade with time. You may also have
- Numbness and weakness of your neck
- Stiffness or weakness of your shoulder on the same side as your surgery
How to join a clinical trial
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Mr Iain Hutchison
Cancer Research UK
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer
This is Cancer Research UK trial number CRUK/07/010.