A trial looking at chemotherapy for Ewing’s sarcoma (rEECur)
Cancer type:
Status:
Phase:
This trial is looking at different types of chemotherapy to treat Ewing’s sarcoma that didn’t respond to treatment or has come back afterwards.
Ewing’s sarcoma is a type of cancer that mainly affects teenagers, young adults and children. This trial is for both adults and children. We use the term 'you', but if you are a parent, we are referring to your child.
More about this trial
Doctors can treat Ewing’s sarcoma with surgery, chemotherapy or radiotherapy. If Ewing’s sarcoma doesn’t respond to these treatments, or comes back afterwards, there isn’t a standard treatment.
In this trial, researchers are comparing different types of chemotherapy that can be used to treat Ewing’s sarcoma that hasn’t responded to treatment or has come back afterwards. They are looking at:
- Ifosfamide (IFOS)
- Ifosfamide and lenvatinib (IFSO-L)
Ifosfamide and etoposide are chemotherapy drugs. Doctors already use these chemotherapy drugs to treat Ewing’s sarcoma that has come back.
Lenvatinib is a called a cancer growth blocker. It works by blocking signals that cancer cells need to grow. It also blocks the cancer cells from making new blood vessels which they need to grow. Doctors already use lenvatinib to treat some cancers including another type of sarcoma.
The aim of the trial is to find out which treatment works best and which has the fewest side effects.
Who can enter
You may be able to join this trial if all of the following apply. You
- Have Ewing’s sarcoma that didn’t respond to the treatment you had, or has come back afterwards
- Are at least 2 years old
- Are well enough to have chemotherapy
- Are willing to use reliable contraception during the trial and for up to a year afterwards if you are sexually active and there is any chance you or your partner could become pregnant
- Have satisfactory blood test results
- Have heart that is working well enough. You have a test for this.
- Have a normal blood pressure or if not your blood pressure is well controlled. Your doctor will check this.
Please note: You must be able to join at least 2 of the 3 treatment groups.
You cannot join this trial if any of these apply. You
- Have a low number of white blood cells called
neutrophils . The trial doctor can advise you about this.
- Have had chemotherapy or an experimental drug in the last 2 weeks
- Have had high dose chemotherapy that kills cells in your bone marrow in the last 8 weeks
- Have had radiotherapy to treat your sarcoma in the last 6 weeks
- Are pregnant or breastfeeding
- Have a high amount of protein in the urine. Your doctor will test for this.
- Had a blockage in an artery caused by a blood clot in the past 6 months
- Had bleeding from the food pipe, stomach or bowel (
digestive system ) in the past 3 weeks
- Have been coughing up blood in the past 3 week
- Had major surgery in the past 3 weeks
- Have had treatment with a
targeted drug called a
tyrosine kinase inhibitor . Your doctor will know if you have.
Trial design
This is an international trial. The researchers need about 700 people to take part worldwide with about 220 people from the UK.
It is a randomised trial. The people taking part are put into treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in.
You will have one of the following
- Ifosfamide (IFOS)
- Ifosfamide and lenvatinib (IFOS-L)
You have chemotherapy in 3 week periods called . You have ifosfamide have 4 cycles of treatment. If your sarcoma responds well, your doctor may decide to give you more cycles of treatment.
If you are in the IFOS group, you have chemotherapy for 5 days in a row every 3 weeks.
If you in the IFOS-L group, you have ifosfamide 5 days in a row every 3 weeks. You have 4 cycles of ifosfamide. Lenvatinib is a capsule. You take it once a day every day for up to 2 years.
Before you start treatment, you may have a central line put in. A central line is a small plastic tube that goes under the skin and into a vein under your collar bone. It will stay in place until you finish treatment. This makes it easier to give treatment and take blood samples.
The trial team will ask you to fill out a questionnaire before you start treatment, after 2 cycles of treatment and after 4 cycles of treatment. The questionnaire will ask about side effects and how you’ve been feeling. This is called a quality of life study.
Hospital visits
You see the trial team and have some tests before you start treatment. The tests can include
Physical examination - Blood tests. This includes tests to check how well your
thyroid gland works.
- Urine tests
- CT scan
- MRI scan
- Bone scan
- X-ray
- Heart trace (ECG)
- Heart scan (ECHO)
Your doctor will decide which type of scan you need, depending on where the sarcoma is. You have the scan before you start treatment. You may also need to have a bone marrow test.
You also have a test to see how well your kidneys are working. This is called a .
You see the trial team and have blood tests regularly during treatment. You have another scan after the 2nd and 4th cycles of chemotherapy. If you have 6 cycles of treatment, you have another scan after the 6th cycle.
When you finish treatment, the trial team will check how you are getting on for a minimum of 5 years. They can do this from information collected at your regular hospital appointments.
Side effects
The most common side effects of the chemotherapy drugs being tested in this trial include
- Hair loss
- Feeling or being sick
- A drop in blood cells causing an increased risk of infection, bleeding problems, tiredness and breathlessness
- Sore mouth
- Dry skin
- Constipation or diarrhoea
The trial team will talk to you about all the possible side effects before you agree to take part.
We have more information about
Location
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 Martin McCabe
Supported by
Cancer Research UK
European Commission’s FP7 health programme
University of Birmingham
Other information
This is Cancer Research UK number CRUK/19/004.
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040