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rEECur - International Randomised Controlled Trial of Chemotherapy for the Treatment of Recurrent and Primary Refractory Ewing Sarcoma
The aim of the rEECur trial is to compare different chemotherapy regimens to determine which is most effective and/or has fewest side effects. It is a randomised trial and is open to patients with a diagnosis of recurrent or primary refractory Ewing sarcoma (ES) from the age of two years old and will recruit 650 patients between 2015 and 2025.
EudraCT number: 2014-000259-99
ISRCTN reference number: ISRCTN 36453794
The objective of rEECur is to identify the best treatment for recurrent and refractory Ewing sarcoma based on the balance between efficacy and toxicity.
rEECur trial schema (pdf)
rEECur is a Multi-Arm, Multi-Stage (MAMS) randomised phase II / phase III, open-label, international trial. Patients will be randomised at trial entry to receive one of the available regimens. Patients must be eligible for randomisation between at least two treatment arms to be eligible for trial entry.
For each arm, the phase II evaluation comprises two stages, with the number of patients needed being dependent on the design parameters. Because arms are introduced at different times, the evaluations will not occur simultaneously for all arms. At each assessment, the outcomes of contemporaneously randomised patients will be compared and one arm will be dropped based on activity and/or toxicity. The remaining arms will continue to recruit. Arms that remain in the study after the required number of phase II patients have been recruited will progress to phase III evaluation. Patients recruited in the phase II stage for each comparison will contribute data to the phase III stage for that comparison.
Using the rolling MAMS design will allow the introduction of novel agents or regimens as new arms, if appropriate. The introduction of new arms will require a substantial amendment and approval by the relevant Competent Authority (the MHRA in the UK). An example of this is the addition of the CE arm which is currently being directly compared to IFOS.
Patient information and the trial protocol can be found on the CRCTU website.
If you have any questions about this trial, please contact the Cancer Research UK Clinical Trials Unit at the University of Birmingham reecur@trials.bham.ac.uk
***The Trial Office cannot give advice on personal clinical questions***