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.

International randomised controlled trial of chemotherapy for the treatment of recurrent and primary refractory Ewing sarcoma - rEECur

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-000259-99-NL

Enrollment

700

Registered

2015-12-29

Start date

2017-04-19

Completion date

Unknown

Last updated

2025-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Recurrent and refractory Ewing sarcoma MedDRA version: 20.0 Level: PT Classification code 10015560 Term: Ewing's sarcoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 27.1 Level: PT Classification code 10015564 Term: Ewing's sarcoma recurrent System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 27.0 Level: LLT Classification code 10015569 Term: Ewing's tumor recur

Interventions

Trade Name: Cyclophosphamide Product Name: Cyclophosphamide Product Code: Cyclophosphamide Pharmaceutical Form: Infusion INN or Proposed INN: Cyclophosphamide CAS Number: 50-18-0 Concentration unit: m

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Principal inclusion criteria - Histologically proven, Ewing or Ewing-like sarcoma of the bone or soft tissues - Radiological evidence of disease progression during or after completion of first or any subsequent line of treatment. - Medically fit to receive trial treatment - Age =2years - Adequate GFR (defined in main protocol eligibility criteria) IFOS-Lenvatinib specific principal inclusion criteria - Adequate liver function - Left ventricular ejection fraction =50% at baseline as determined by echocardiography. - Normal or adequately controlled blood pressure (BP) Are the trial subjects under 18? yes Number of subjects for this age range: 305 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 395 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0

Exclusion criteria

Exclusion criteria: Principal exclusion criteria - Radiotherapy to target lesion within previous six weeks - Cytotoxic chemotherapy or other investigational medicinal product within previous two weeks - Myeloablative therapy within previous eight weeks - Previous randomisation in the rEECur trial IFOS-Lenvatinib specific principal exclusion criteria - Significant proteinuria (defined in main protocol eligibility criteria) - 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

Design outcomes

Primary

Measure	Time frame
Main Objective: The objectives of the study are to compare systemic anti-cancer therapy regimens in recurrent/refractory ES in order to identify the best one with respect to efficacy (imaging response and survival), toxicity and acceptability to patients. ;Secondary Objective: We will also measure and assess: Objective imaging response (OR) after 2, 4, and 6 cycles for CE and after 2 and 4 cycles for IFOS and IFOS-L, and at the end of trial treatment for all arms, Progression-free survival time (PFS), Overall survival time (OS), Toxicity, PET-CT response after 4 cycles, Quality of life (QoL), and Days spent in hospital ;Primary end point(s): Event-free survival time;Timepoint(s) of evaluation of this end point: At every clinic visit	—

Measure

Time frame

Main Objective: The objectives of the study are to compare systemic anti-cancer therapy regimens in recurrent/refractory ES in order to identify the best one with respect to efficacy (imaging response and survival), toxicity and acceptability to patients. ;Secondary Objective: We will also measure and assess: Objective imaging response (OR) after 2, 4, and 6 cycles for CE and after 2 and 4 cycles for IFOS and IFOS-L, and at the end of trial treatment for all arms, Progression-free survival time (PFS), Overall survival time (OS), Toxicity, PET-CT response after 4 cycles, Quality of life (QoL), and Days spent in hospital ;Primary end point(s): Event-free survival time;Timepoint(s) of evaluation of this end point: At every clinic visit

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Secondary

Measure	Time frame
Secondary end point(s): - Objective imaging response (OR) according to RECIST 1.1 criteria - Progression-free survival time (PFS) - Overall survival time (OS) - Toxicity, defined by National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v4.0 - PET-CT response after 4 cycles - Quality of life (QoL) - Days spent in hospital;Timepoint(s) of evaluation of this end point: PFS and OS will be assessed at every clinic visit QoL will be assessed at baseline and after 2 and 4 cycles of chemotherapy Adverse events, toxicity and days spent in hospital following each cycle will be assessed prior to the start of the next chemotherapy cycle and after the last chemotherapy cycle for cycles 1-4 (Ifosfamide regimen) and cycles 1-6 (other chemotherapy regimens)	—

Measure

Time frame

Secondary end point(s): - Objective imaging response (OR) according to RECIST 1.1 criteria - Progression-free survival time (PFS) - Overall survival time (OS) - Toxicity, defined by National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v4.0 - PET-CT response after 4 cycles - Quality of life (QoL) - Days spent in hospital;Timepoint(s) of evaluation of this end point: PFS and OS will be assessed at every clinic visit QoL will be assessed at baseline and after 2 and 4 cycles of chemotherapy Adverse events, toxicity and days spent in hospital following each cycle will be assessed prior to the start of the next chemotherapy cycle and after the last chemotherapy cycle for cycles 1-4 (Ifosfamide regimen) and cycles 1-6 (other chemotherapy regimens)

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Countries

Australia, Austria, Belgium, Czechia, Czech Republic, Denmark, Finland, France, Germany, Hungary, Italy, Netherlands, New Zealand, Norway, Poland, Spain, Switzerland, United Kingdom

Contacts

Public ContactMaria Khan

University of Birmingham

reecur@trials.bham.ac.uk01214151060

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026