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 ages of four to 49 years old and will recruit 525 patients between 2015 and 2018.
The objectives of the study are to compare four chemotherapy regimens in recurrent/refractory ES: cyclophosphamide & topotecan, irinotecan & temozolomide, gemcitabine & docetaxel, and high dose ifosfamide, in order to identify the best one for use as a backbone in future treatment with respect to efficacy (imaging response and survival), toxicity and acceptability to patients.
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 up to four regimens. Some patients will not be eligible for randomisation to one or more chemotherapy regimens and will be randomised between the remaining regimens for which they are eligible.
The phase II part will comprise two stages. The first stage will include four chemotherapy arms. When 50 patients are recruited to each arm, one arm will be dropped based on activity and/or toxicity. The second stage will be a 3-way randomisation between the remaining arms. When 25 additional patients have been recruited to each arm, a second arm will be dropped based on activity and/or toxicity. The remaining two arms will progress to phase III evaluation. Patients in these two arms who took part in the phase II stage will contribute data to the phase III stage.
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).
If you have any questions about this trial, please contact the Cancer Research UK Clinical Trials Unit at the University of Birmingham firstname.lastname@example.org
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