A trial looking at the treatment of local cancer spread in head and neck cancers

This trial is comparing surgery to remove lymph nodes in squamous cell cancers of the head and neck with a ‘watch and wait’ policy using PET-CT scanning.

Many head and neck cancers are squamous cell carcinomas. Squamous cells are the flat, skin like cells that cover the inside of the mouth, nose, larynx and throat. Carcinoma just means cancer. So squamous cell carcinoma is cancer that starts in these cells.

Doctors usually treat head and neck squamous cell cancer with chemotherapy and radiotherapy, given at the same time. This is called chemoradiation. We know from research that this works better than radiotherapy alone.

Sometimes, the cancer has spread to the lymph nodes in the neck. In this situation, you usually have surgery to remove the lymph nodes. This is known as a neck dissection. It is the standard treatment, but the surgery can have side effects.

We know from research that some people will not have any cancer in their lymph nodes after chemoradiation and so do not need to have surgery. But until now, it has been difficult for doctors to know whether or not there are any cancer cells still there after chemoradiation. Now, a new type of scanner, called a PET-CT scanner can help doctors to see whether or not there are still cancer cells in the neck.

In this trial, half the people taking part will have surgery and chemoradiation. The other half will have chemoradiation, and then a PET-CT scan. They will only have a lymph node dissection if the scan shows there are (or might still be) cancer cells in the lymph nodes.

The aims of the trial are

To see if one treatment is better than the other for people with squamous cell cancer of the head and neck
To learn more about the side effects and how they affect quality of life

Recruitment

Start 01/10/2007

End 30/09/2010

Phase

Phase 3

Who can enter

You can enter this trial if

You have been diagnosed with squamous cell cancer of the mouth or oropharynx, larynx, or hypopharynx, or that started somewhere else in the head or neck
Your cancer has spread into the lymph nodes in your neck - the lymph nodes can be on either side of your neck or on both sides, as long as none of them are bigger than 6cm across
Your doctors aim to cure your cancer with chemoradiation
You are well enough to have surgery and chemoradiation
You are at least 18 years old

You cannot enter this trial if you

Have cancer that started in the nasopharynx
Have head and neck cancer that is not squamous cell carcinoma
Are having surgery to remove the area where the cancer started (the primary tumour for example, the tonsil or the base of your tongue)
Have no cancer cells in your lymph nodes OR only one node is affected, which is on the same side of your neck as the tumour and is no bigger than 3cm across
Are already having chemotherapy, either on its own or with radiotherapy
Are having radiotherapy alone
Are having treatment but your doctors don’t expect this to cure your cancer (palliative treatment)
Have cancer that has spread to other parts of your body (apart from the lymph nodes in your neck)
Have already had treatment for head and neck squamous cell cancer
Have had another type of cancer in the last 5 years apart from basal cell skin cancer or carcinoma in situ of the cervix
Are pregnant

Trial design

The trial will recruit about 560 people at 20 hospitals in the UK. It is a randomised trial. The people taking part are put into one of 2 treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in.

If you are in group 1, you will have surgery to remove the lymph nodes from your neck. And you will have chemoradiation. You may have surgery first, followed by chemoradiation. Or you may have chemoradiation first, followed by surgery 4 to 8 weeks later. Exactly how you have this treatment will depend on the chemotherapy regime that your hospital uses. Your doctors will explain this to you.

Between 1 and 3 months after your treatment finishes, you have a CT scan. Your doctors will also examine the area where your tumour was. You may need to have this examination under general anaesthetic.

If you are in group 2, you will have chemoradiation, but not surgery. About 3 months after your treatment, you have a PET-CT scan to see if there are any cancer cells in your lymph nodes. The doctors will also examine the area where the tumour was. You may need to have a general anaesthetic for this.

If the PET-CT scan shows that there are still cancer cells in your neck (or if there is some doubt), you will have surgery to remove the lymph nodes. Your doctor will make a referral for you to have this within 2 to 4 weeks. If no cancer is seen or suspected on the scan, you will not have any more treatment.

With your permission, the researchers will get a sample of the tissue taken if you have an operation. These samples will be stored safely and may be used in future for research purposes.

You will be asked to fill out some questionnaires before you start treatment, after your chemoradiation, then 6 months, 1 year and 2 years after your treatment. The questionnaires will ask you about any side effects you have had and about how you have been feeling. This is called a quality of life study.

Hospital visits

You will see the doctors and have some tests before you start treatment. The tests include

Physical examination
CT scan or MRI scan
Chest X-ray
Blood tests

The number of hospital visits you have will depend on whether or not you have surgery and the chemotherapy regime that your hospital uses.

People in both groups will have some extra blood tests at the beginning of the trial, after 3 months and a year after the end of treatment.

After you finish your treatment, you will see the trial doctors

Every month for the first year
Every 2 months the next year

Side effects

There is more information about the general side effects of chemotherapy and the side effects of radiotherapy to the head and neck on CancerHelp UK. In this trial, you have chemotherapy and radiotherapy at the same time. The side effects are the same as for each individual treatment. But some are likely to be more severe.

If you have a neck dissection, the side effects can include

Pain
Infection
Problems with the wound healing
Bleeding or blood clots
Stiffness or loss of movement in your shoulder

If you do have problems after your surgery, this can delay the start of your chemoradiation treatment.

If you are in group 2 and the doctors find that you do need to have a neck dissection, the surgery can be more complicated after you’ve had chemoradiation.