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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Prof
Martin
McCabe
+44 (0) 121 415 9877
reecur@trials.bham.ac.uk
More information about this study, what is involved and how to take part can be found on the study website.
Paediatrics, Recurrent/refractory Ewing sarcoma
This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
You can take part if:
You may not be able to take part if:
Current participant exclusion criteria (since 03-May-2023) as of 10/01/2025: 1. Absolute Neutrophil Count (ANC) <1.0 x 109/L or platelets <75 x 109/L.2. Cytotoxic chemotherapy or other investigational medicinal product (IMP) within the previous two weeks.3. Myeloablative therapy within the previous eight weeks.4. Radiotherapy to target lesion within the previous six weeks.5. Pregnant or breastfeeding women.6. Pre-existing medical condition that would necessitate a dose modification during cycle 1 as described in section 7.7. Any central neurotoxicity with previous ifosfamide treatment8. Clinical evidence of nephrotic syndrome9. Follow-up is not possible due to social, geographic or psychological reasons.10. Previous randomisation into the rEECur trial11. Patients with a contraindication or hypersensitivity to any IMP may not be randomised to receive an arm that contains the contraindicated IMP.12. Patients who have previously received one of the trial regimens off-trial may not be randomised to receive that regimen again. Patients who have had ifosfamide during first-line therapy may receive the IFOS or IFOS-L arm. There is no requirement for a minimum time between receiving first-line ifosfamide and entry to rEECur.
Additional exclusion criteria for the IFOS-L arm: 1. Clinically significant ECG abnormality, including a marked baseline prolonged QT or QTc interval (eg, a repeated demonstration of a QTc interval >480 msec).2. History of aneurysm3. Arterial Thromboembolism in previous 6 months4. Gastrointestinal or non-gastrointestinal fistula.5. Gastrointestinal bleeding or active haemoptysis within the previous 3 weeks6. Major surgery within the previous 3 weeks7. Previous treatment with tyrosine kinase inhibitors8. Radiographic evidence of intratumoral cavitation, encasement, or invasion of a major blood vessel, or proximity to major blood vessels with the potential risk of severe haemorrhage associated with tumor shrinkage/necrosis after lenvatinib therapy.
Previous participant exclusion criteria as of 14/12/2018:1. Bone marrow infiltration resulting in Absolute Neutrophil Count (ANC) <1.0 x 109/L or platelets <75 x 109/L.2. Cytotoxic chemotherapy or other investigational medicinal product (IMP) within previous two weeks.3. Myeloablative therapy within previous eight weeks.4. Radiotherapy to target lesion within previous six weeks.5. Pregnant or breastfeeding women.6. Follow-up not possible due to social, geographic or psychological reasons.7. Previous randomisation into the rEECur trial
Additional criteria for specific arms:1. Patients with a contraindication to any IMP may be entered into the study but may not be randomised to receive an arm that contains a contraindicated IMP. They will be eligible for trial entry as long as they can be randomised between a minimum of two study arms.2. Patients who are unable to receive one or more IMPs due to local or national funding arrangements will be eligible for trial entry as long as they can be randomised between a minimum of two study arms.3. Patients and investigators may decline randomisation to one or more trial regimens but will be eligible for trial entry as long as they can be randomised between a minimum of two study arms.4. Patients who have previously received one of the trial regimens off-trial may not be randomised to receive that chemotherapy regimen again. However, patients who have received cyclophosphamide during first line therapy may be randomised to receive the TC arm and patients who have had ifosfamide during first line therapy may receive the ifosfamide arm if they do not have pre-existing renal or other toxicity that would necessitate in rEECur a dose modification. There is no requirement for a minimum time between receiving first line ifosfamide and entry to rEECur.
Previous participant exclusion criteria:1. Conventional dose cytotoxic chemotherapy or other investigational medicinal product (IMP) within previous four weeks2. Myeloablative dose chemotherapy within previous 8 weeks3. Radiotherapy to target lesions within previous 6 weeks4. Pregnant or breastfeeding women5. Follow-up not possible due to social, geographic or psychological reasons
Additional criteria for specific arms:1. Patients who have previously received one of the randomised regimens may not be randomised to receive that chemotherapy regimen again2. Patients with a contraindication to any IMP may be entered into the study but may not be randomised to receive an arm that contains a contraindicated IMP3. Patients who have received cyclophosphamide during first-line therapy may be randomised to receive the TC arm4. Patients who have had ifosfamide during first-line therapy may be randomised to receive the IFOS arm if they do not have pre-existing renal or other toxicity that would necessitate a dose modification. There is no requirement for a minimum time between receiving first-line ifosfamide and randomisation to IFOS as part of the rEECur trial.
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
This information has not yet been provided by the study team. You'll have an opportunity to discuss any risks and benefits that may be associated with this study prior to consenting to taking part.
Prof
Martin
McCabe
+44 (0) 121 415 9877
reecur@trials.bham.ac.uk
More information about this study, what is involved and how to take part can be found on the study website.
The study is sponsored by University of Birmingham (UK) and funded by Seventh Framework Programme.
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
You can print or share the study information with your GP/healthcare provider or contact the research team directly.
