A trial looking at PET scans and treatment for Hodgkin's lymphoma (RATHL)

This trial is to see if doctors can use PET scans to make decisions about treatment for Hodgkin’s lymphoma. The trial is funded by Cancer Research UK.

Doctors usually treat Hodgkin's lymphoma with either chemotherapy or radiotherapy, or a combination of both. Most people have ABVD chemotherapy for 6 to 8 months. Many people are cured with this. But some people need stronger treatment, and others could be cured with less treatment.

One of the drugs included in ABVD is called bleomycin. It can cause lung damage and doctors want to see if some people can safely have less of it. Until now, it has been difficult for doctors to tell who could have less treatment and who needs more. A type of scan called a PET scan may help by showing if there are areas of active cancer. This can tell doctors how you are responding to treatment. If the scan shows there is still active lymphoma, it is called a positive scan. If there is no abnormal activity, it is a negative scan.

In this trial, you have a PET scan early in your treatment. Depending on the results of the scan, doctors can change the rest of your treatment. The aims of the trial are to find out if

PET scanning after 2 cycles of ABVD is a reliable way of making decisions about treatment
It is safe for people who have a negative scan to stop having bleomycin
More intensive chemotherapy helps people who have a positive scan

Recruitment

Start 01/08/2008

End 01/12/2012

Phase

Phase 3

Who can enter

You can enter this trial if you

Have been diagnosed with Hodgkin’s lymphoma that is stage 2B, 3 or 4 (you may be able to take part if you have stage 2A, the trial doctor will advise you about this)
Have satisfactory blood test results
Are well enough to take part in the trial (performance status 0, 1, 2 or 3)
Are willing to use reliable contraception during the trial if there is any chance you or your partner could become pregnant
Are at least 18 years old
Have access to an approved PET-CT scanner

You cannot enter this trial if you

Have Hodgkin’s lymphoma that is affecting your brain or spinal cord
Have already had treatment for Hodgkin’s lymphoma
Have another type of cancer, apart from non melanoma skin cancer or squamous cell cancer of the cervix that has been completely removed, or any other cancer if you have been free of the disease for at least 5 years
Have heart problems
Have diabetes that is not well controlled
Have any other medical condition that is not well controlled with medicine
Are known to be HIV, Hepatitis B or Hepatitis C positive
Are pregnant or breastfeeding

Trial design

The trial will recruit 1,200 people at a number of hospitals in the UK. Everybody taking part will have 2 cycles of treatment with ABVD chemotherapy, followed by a PET scan.

If the PET scan is negative, your lymphoma has responded well to the treatment. You will be put into one of two treatment groups by a computer. This is called randomisation

Group 1 will have 4 more cycles of ABVD
Group 2 will have 4 more cycles of treatment without the bleomycin (AVD)

If you have a positive PET scan, you will change to a more intensive type of chemotherapy called BEACOPP. This is made up of the drugs doxorubicin, cyclophosphamide, etoposide, procarbazine, bleomycin, vincristine and prednisolone.

There are 2 different ways you can have BEACOPP. One is called BEACOPP 14 and the other is BEACOPP escalated. They both work equally well and the exact treatment you have will depend on the hospital where you have your treatment.

If you have BEACOPP 14, you have chemotherapy in 2 week (14 day) cycles of treatment. After 4 cycles (8 weeks) of treatment, you have another PET scan. Depending on the results of the scan, you will either have 2 more cycles of the same treatment or your doctor will talk to you about changing to a different treatment.

If you have BEACOPP escalated, you have the same drugs, but in 3 week cycles of treatment, with higher doses of some of the drugs. After 3 cycles (9 weeks) of treatment, you have another PET scan. Depending on the results of the scan, you will either have one more cycle of the same treatment, or your doctor will talk to you about changing to a different treatment.

Some people will have radiotherapy as well. If the PET scan after 2 cycles of treatment was negative, it is unlikely that you will need to have radiotherapy. But your doctor will discuss this with you.

As part of this trial, the research team will ask for a sample of the biopsy you had taken when your Hodgkin’s lymphoma was diagnosed. This will be sent to a specialist laboratory in Leeds and used for research purposes only.

Hospital visits

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

Physical examination
Blood tests
Lung function tests
Bone marrow test
PET-CT scan
Heart trace (ECG}
Heart scan (echocardiogram or MUGA)
CT scan
Pregnancy test (if there is any chance you could be pregnant)

The number of hospital visits will depend on which chemotherapy you have and whether or not you have radiotherapy. If you do have radiotherapy, you have treatment every day (Monday to Friday) for 3 to 4 weeks.

You see the doctor and have blood tests before each cycle of chemotherapy. You have a CT scan 3 months and 12 months after your treatment. When you finish your treatment, you will see the trial team

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

Side effects

The side effects of ABVD or BEACOPP chemotherapy include

Tiredness (fatigue)
A drop in the number of white blood cells causing an increased risk of infection
Sickness
Hair loss
Changes to the skin or nails
Numbness and tingling in the hands and feet (peripheral neuropathy)

BEACOPP can also cause a sore mouth and bladder irritation.

Chemotherapy for Hodgkin’s lymphoma may have a permanent effect on your fertility. It is important to talk to your doctor about this before you start treatment.

The side effects of radiotherapy depend on which part of the body is being treated. There is information about side effects of radiotherapy for Hodgkin’s lymphoma, ABVD, cyclophosphamide, etoposide, procarbazine, prednisolone and vincristine on CancerHelp UK.