A trial looking at radiotherapy to the chest after chemotherapy and rituximab for primary mediastinal large B cell lymphoma (IELSG 37)
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
Cancer type:
Status:
Phase:
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.
More about this trial
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.
Who can enter
You may be able to enter this trial if
- You have been diagnosed with primary mediastinal large B cell lymphoma (PMBCL) and haven’t had any other treatment yet
- You are going to have chemotherapy and rituximab with the aim of curing your lymphoma or you have started chemotherapy and rituximab in the past 4 weeks
- Your lymphoma cells have a protein called CD20 on their surface
- You are at least 18 years old
- You are willing to use reliable contraception during the trial if there is any chance you or your partner could become pregnant – women taking part must carry on using contraception for at least 3 months after treatment, men taking part must continue to use condoms for at least a year
You cannot enter this trial if you
- Have lymphoma that has spread outside your chest
- Have had any other cancer in the last 5 years apart from non melanoma skin cancer or carcinoma in situ of the cervix
- Have had a heart attack in the last year or have certain other heart problems – the trial team can advise you about this
- Are known to be HIV positive
- Are pregnant or breastfeeding
Trial design
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
- There are any signs of the lymphoma coming back
- You have any long term treatment side effects
A final follow up will take place 10 years after randomisation.
Hospital visits
You see the trial team and have some tests before you start treatment. The tests include
- Physical examination
- Blood tests
- Bone marrow test
- Chest X-ray
- CT scan
- PET-CT scan
- Heart scan (
echocardiogram ) - Heart trace (
ECG )
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.
Side effects
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
- Irritation or changes to your skin
- Heart problems
- Other cancers such as breast cancer, thyroid cancer and lung cancer
We have more information about the side effects of chest radiotherapy.
Recruitment start:
Recruitment end:
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.
Chief Investigator
Dr Andrew Davies
Supported by
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
Other information
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
