
Last year in the UK over 60,000 cancer patients enrolled on clinical trials aimed at improving cancer treatments and making them available to all.
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This trial is trying to find the best way to treat a rare type of non Hodgkin lymphoma called primary mediastinal large B cell lymphoma. This trial is supported by Cancer Research UK.
Large B cell lymphoma is a type of high grade non Hodgkin lymphoma. If it starts in in the centre of your chest (the area known as the
), it is called primary mediastinal large B cell lymphoma or PMBCL.
Doctors usually treat PMBCL with chemotherapy and a drug called rituximab. After this, you may also have radiotherapy to your chest to reduce the risk of the lymphoma coming back.
But having radiotherapy to your chest can increase the risk of heart problems and of getting another cancer later on. Some doctors think that leaving the radiotherapy out of treatment doesn’t make it any more likely that your lymphoma will come back.
The aim of this trial is to see if it is safe to leave radiotherapy out of the treatment plan without increasing the risk of the lymphoma coming back.
You may be able to enter this trial if
You cannot enter this trial if you
Everybody joining the trial has a PET-CT scan. This is either before starting chemotherapy and rituximab or within 4 weeks of starting treatment.
You can still join this study if you have already started treatment with chemotherapy and rituximab. You can enter within 4 weeks of cycle 1 of your treatment.
After treatment for primary mediastinal large B cell lymphoma, a lot of people still have some abnormal tissue in their chest. This may be lymphoma, but often it is just scar tissue. A PET-CT can help to show the difference between active lymphoma cells and scar tissue.
When you finish your chemotherapy and rituximab treatment, you have another PET-CT scan to see how well your lymphoma has responded to treatment.
If the scan shows that there are no longer any active lymphoma cells, it is called a negative PET-CT scan. If there are still some active lymphoma cells, it is called a positive scan.
If you have a positive PET-CT scan after finishing your chemotherapy and rituximab, your doctor will decide if you need to have any further treatment. If you have a negative PET-CT scan, you are put into 1 of 2 groups by a computer. This is called randomisation. Neither you nor your doctor will be able to decide which group you are in.
People in one group have radiotherapy for 2 to 3 weeks. People in the other group have no further treatment for their lymphoma.
Everybody has regular follow up appointments for up to 5 years. The trial team will check if
A final follow up will take place 10 years after randomisation.
You see the trial team and have some tests before you start treatment. The tests include
You go to hospital regularly during chemotherapy, but no more than if you were having . The PET-CT scan you have a few weeks after finishing chemotherapy is also standard treatment.
If you have a negative PET-CT scan and you are in the group having radiotherapy, you will go to hospital every day for 2 to 3 weeks to have the treatment.
Everybody will see the trial team and have blood tests and scans every 3 months for 2 years. After that, you see the trial team and have blood tests every 6 months for the next 3 years. You may have more scans during this time.
The researchers will ask your permission to collect information from your medical notes for up to 10 years to see how you are getting on.
It is possible that not having radiotherapy may put you at higher risk of your lymphoma coming back. Your doctor will check for this during your follow up appointments.
If you do have radiotherapy, the possible side effects include
We have more information about the side effects of chest radiotherapy.
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Dr Andrew Davies
Cancer Research UK
Experimental Cancer Medicine Centre (ECMC)
International Extranodal Lymphoma Study Group (IELSG)
NIHR Clinical Research Network: Cancer
Southampton Clinical Trials Unit
University Hospital Southampton NHS Foundation Trust
This is Cancer Research UK trial number CRUK/12/040.
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
Last year in the UK over 60,000 cancer patients enrolled on clinical trials aimed at improving cancer treatments and making them available to all.