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
Inclusion Criteria13
- Histologically confirmed Ewing or Ewing-like sarcoma of the bone or soft tissues. Histological confirmation either at initial diagnosis or disease progression.
- Radiological evidence of disease progression during or after completion of first or any subsequent line of treatment.
- Age greater than or equal to 2 years.
- Eligible for randomisation between at least two open study arms.
- Patient assessed as medically fit to receive trial treatment
- Date of planned randomisation within 4 weeks of baseline imaging.
- Documented negative pregnancy test for female patients of childbearing potential.
- Patient agrees to use effective contraception during therapy and for 12 months after last trial treatment, where applicable.
- Written informed consent from the patient and/or parent/legal guardian.
- Adequate GFR
- Adequate liver function
- Left ventricular ejection fraction greater than or equal to 50% at baseline as determined by echocardiography.
- Normal or adequately controlled blood pressure (BP)
Exclusion Criteria12
- Absolute Neutrophil Count (ANC) <1.0 x 10^9/L or platelets <75 x 10^9/L.
- Cytotoxic chemotherapy or other investigational medicinal product (IMP) within previous two weeks.
- Myeloablative therapy within previous eight weeks.
- Radiotherapy to target lesion within previous six weeks.
- Pregnant or breastfeeding women.
- Follow-up not possible due to social, geographic or psychological reasons.
- Previous randomisation into the rEECur trial
- Significant proteinuria
- Arterial Thromboembolism in previous 6 months
- Gastrointestinal bleeding or active haemoptysis within previous 3 weeks
- Major surgery within previous 3 weeks
- Previous treatment with tyrosine kinase inhibitors
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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
Locations(28)
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ACTRN12618001825246