A trial using PET scans to help decide treatment options for early stage Hodgkin's lymphoma (RAPID)

Please note this trial is no longer recruiting patients.

This trial is to see if PET scans can help doctors decide if radiotherapy is needed after chemotherapy for Hodgkin’s lymphoma.

Hodgkin’s lymphoma used to be called Hodgkin’s disease. A lymphoma is a cancer of the lymphatic system. Doctors usually treat early stage Hodgkin’s lymphoma with chemotherapy and radiotherapy. These treatments often work very well, and between 75 and 95 out of 100 people (75% to 95%) are cured.

At the moment there is no way of knowing for sure how well chemotherapy has worked. So all patients go on to have radiotherapy after chemotherapy. But doctors think that some patients may be having radiotherapy (and the unwanted side effects) without really needing it.

A scan called a 'PET scan' may help with this. PET stands for ‘positron emission tomography’. It is a scan that shows areas of active cancer in the body, rather than ‘abnormal’ areas that may be something harmless such as scar tissue. Doctors hope that it will be able to show if chemotherapy alone has killed all the cancer cells or not.

The idea is that if a person’s cancer has completely gone, they will not need to have radiotherapy. If some cancer remains, they will.

The aim of this trial is to see if a PET scan can help doctors decide who needs further treatment for early stage (stage 1a or 2a) Hodgkin’s lymphoma.

Recruitment

Start 01/11/2003

End 02/08/2010

Phase

Phase 3

Who can enter

You can enter this trial if you

Have stage 1a or 2a Hodgkin’s lymphoma
Have not yet had treatment
Are well enough to have chemotherapy and radiotherapy
Are aged between 16 and 75
Are able to travel to the nearest hospital with a PET scanner (these are in London, Manchester, Aberdeen and Northwood, Middlesex)
Are willing to use contraception while you are taking part in the trial and for 6 months afterwards, if there is any chance you or your partner could become pregnant

You cannot enter this trial if you

Have already had treatment for your Hodgkin’s lymphoma
Have had any other cancer in the past, apart from basal cell skin cancer or carcinoma in situ of the cervix
Have any other serious medical condition
Are pregnant or breastfeeding

Trial design

This is a phase 3 trial. It will recruit 600 patients from the UK. All the people taking part will have chemotherapy and then have a PET scan and a CT scan. They will then be divided into groups depending on the results of the scan.

First of all you will have a chemotherapy regime called ABVD. This is the standard treatment for Hodgkin’s lymphoma. It includes the drugs doxorubicin (Adriamycin), bleomycin, vinblastine and dacarbazine. You have the treatment in 4 week cycles. Twice every 4 weeks (on days 1 and 15) you will have all 4 drugs through a drip into a vein. You will have 3 cycles. After that you will have a PET scan.

If your PET scan shows that you still have some cancer cells remaining, you will have one more cycle of ABVD (making 4 altogether), and then have radiotherapy.

If your PET scan shows that you don’t have any cancer remaining, you will be put into 1 of 2 groups by a computer. Neither you nor your doctor will be able to decide which group you are in. This is called ‘randomisation’.

If you are in group A, you will have radiotherapy.

If you are in group B, you will not have any further treatment. But if there are any signs in the future that your cancer has come back, you will have radiotherapy then.

Hospital visits

You will have some tests before you can take part in this trial. These include

Physical examination
Blood tests
Chest X-ray
CT scan of your neck, chest, abdomen and pelvis

You will go to hospital once a fortnight to have chemotherapy. If you have radiotherapy you will go to hospital once a day (Monday to Friday) for 3 weeks.

When you have the PET scan you will have to lie flat for about an hour. And not have anything to drink for about 6 hours beforehand. The scan itself may take up to an hour. The doctors may give you something to help you relax and lie still for the scan. If they do, you will not be able to drive yourself home afterwards.

You will have the chemotherapy and radiotherapy treatment at the hospital closest to you that is taking part in the trial. But not all of these hospitals will have a PET scanner, so you may have to travel further for that. Your doctors will be able to tell you where the nearest hospital with a PET scanner is.

After you finish treatment, you will see the doctors

Every 3 months for 1 year
Every 4 months for the 2nd year
Every 6 months for the 3rd year
Once a year after that

You will have blood tests and a physical examination at each visit. You will have a CT scan after 6 months, 1 year and 2 years.

Side effects

The most common side effects of ABVD chemotherapy are

A drop in blood cells causing an increased risk of infection, bleeding or bruising problems, tiredness and shortness of breath
Feeling or being sick
Hair loss
Chills and fever
Sore mouth

There is more information about ABVD chemotherapy on CancerHelp UK.

The side effects of radiotherapy include

Red or sore skin to the treatment area
Tiredness
Hair loss in the treatment area only

The side effects of radiotherapy will depend on the area of the body that is treated. For example, if you have radiotherapy to your abdomen, you may have diarrhoea or feel sick. There is more information about radiotherapy for Hodgkin’s lymphoma on CancerHelp UK.

You will have ABVD and radiotherapy whether you take part in this trial or not, because they are the standard treatments for Hodgkin’s lymphoma. So you will not have any additional side effects as a result of taking part in this trial.

As far as we are aware, PET scans do not cause any side effects.