rEECur: Chemotherapy for the treatment of recurrent and primary refractory Ewing sarcoma
International Randomised Controlled Trial of Chemotherapy for the Treatment of Recurrent and Primary Refractory Ewing Sarcoma
University of Birmingham
600 participants
Nov 25, 2018
Interventional
Conditions
Summary
The purpose of this study is to determine which of the most commonly used chemotherapy used in recurrent and primary refractory Ewing sarcoma is most beneficial. Who is it for? You may be eligible for this study if you are aged 2 years or above and have been diagnosed with relapsed or refractory Ewing sarcoma. Study details: Participants in this trial will be randomly allocated to one of the available treatment groups. Before treatment starts the following routine tests will be performed: Physical check-up including measuring height and weight Blood tests +/- urine tests Assessment of kidney function called a GFR. Scans (which may include CT, PET-CT, MRI, bone scan, x-ray). The doctor will decide which type of scans needed depending on where the tumour is located. A quality of life questionnaire will also be completed before treatment commences. During trial treatment While you are having chemotherapy treatment you will be carefully monitored using the same routine tests that would be used if you were having chemotherapy but were not in the trial. These routine tests will include blood +/- urine tests, scans and GFR. These tests are to ensure that you are fit to continue chemotherapy. In addition if you have had a PET-CT scan before treatment, you will have another PET-CT scan after 4 cycles of chemotherapy. You will be asked to complete two more quality of life questionnaires, one on completion of cycle 2 and one on completion of cycle 4. All treatments in this study are those which are currently used routinely for treatment of Ewing sarcoma. It is hoped that this research will help to determine which of the treatments is most effective in improving overall survival, side effects, tumour shrinkage, quality of life and days spent in hospital.
Eligibility
Plain Language Summary
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This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
A comparison of widely used chemotherapy regimens for the treatment of Ewing sarcoma, a type of bone cancer, to see which is most effective and/or has the fewest side effects. High dose Ifosfamide (IFOS): 4 cycles of 21 days, additional cycles at clinician's discretion. IV infusion of Ifosfamide 3g/m2 on days 1, 2, 3, 4, 5 High dose Ifosfamide and Lenvatinib (IFOS-L), 4 cycles, of 21 days, additional IFOS cycles at clinician’s discretion. Lenvatinib capsules taken once daily continuously throughout and for up to 2 years in total. IV infusion of Ifosfamide 3g/m2 on days 1, 2, 3, 4, 5 & 14mg/m2 (oral) starting d1 then daily, continuous Please note – Gemcitabine and Docetaxel (GD) arm closed in November 2018 and Irinotecan and Temozolomide (IT) arm closed in March 2020. Please note- Topotecan and Cyclophosphamide (TC) arm was closed in November 2021. The closed arms: Gemcitabine and Docetaxel (GD): 6 cycles of 21 days, additional cycles at clinician's discretion. IV infusion of Gemcitabine 900mg/m2 on days 1, 8. IV infusion of Docetxal 800mg/m2 on day 8. Irinotecan and Temozolomide (IT): 6 cycles of 21 days, additional cycles at clinician's discretion. IV infusion of Irinotecan 50mg/m2 on days 1, 2, 3, 4, 5 Temozolomide 100mg/m2 orally on days 1, 2, 3, 4, 5 Topotecan and Cyclophosphamide (TC): 6 cycles of 21 days, additional cycles at clinician's discretion. IV Infusion of Topotecan 0.75mg/m2 and Cyclophosphamide 250mg/m2 on day 1, 2, 3, 4, 5 Carboplatin and Etoposide (CE): 6 cycles of 21 days, additional cycles at clinician’s discretion. IV infusion of Carboplatin 400mg/m2 on day 1, and IV infusion of Etoposide on Days 1, 2, 3
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ACTRN12618001825246