A comparison of four 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 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-000259-99-CZ

Enrollment

400

Registered

2015-06-29

Start date

2017-03-23

Completion date

Unknown

Last updated

2024-12-09

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: 19.1 Level: LLT Classification code 10015567 Term: Ewing's tumor localized System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 19.1 Level: LLT Classification code 10015763 Term: Extra-osseous Ewing's sarcoma NOS System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 19.1 Level: LLT Classification code 10015566 Term: E

Interventions

Product Name: Cyclophosphamide Product Code: Cyclophosphamide Pharmaceutical Form: Infusion INN or Proposed INN: Cyclophosphamide CAS Number: 50-18-0 Concentration unit: mg milligram(s) Concentration

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Histologically confirmed Ewing sarcoma. 2. Disease progression (during or after completion of first line treatment) or any subsequent recurrence OR Refractory disease, defined by progression during first line treatment or within 12 weeks of its completion. Disease progression will be based on Response Evaluation Criteria In Solid Tumors (RECIST). The appearance of new bone lesions on bone scan will require confirmation with cross-sectional imaging. 3. Soft tissue disease component evaluable by cross-sectional imaging. Patients with bone disease without a measurable soft tissue component or bone marrow disease only will be eligible for the study but will not contribute to the phase II primary outcome measure. 4. Age =4 years and =65 years) no F.1.3.1 Number of subjects for this age range 0

Exclusion criteria

Exclusion criteria: 1.Bone marrow infiltration resulting in absolute neutrophil count (ANC) < 1.0 x 109/l or platelets <75 x 109/l 2.Cytotoxic chemotherapy or other investigational medicinal product (IMP) within previosu two weeks. 3.Myeloablative therapy within previous eight weeks. 4.Radiotherapy to target lesion within previous six weeks. 5.Pregnant or breastfeeding women. 6.Follow-up not possible due to social, geographic or psychological reasons. 7. Previous randomisation into the rEECur trial

Design outcomes

Primary

Measure	Time frame
Main Objective: 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.;Secondary Objective: N/A;Primary end point(s): Phase II: Objective response as measured by RECIST criteria Phase III: Event-free survival;Timepoint(s) of evaluation of this end point: the main assessment time point for the phase II study will be at baseline and after 4 cycles of chemotherapy	—

Measure

Time frame

Main Objective: 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.;Secondary Objective: N/A;Primary end point(s): Phase II: Objective response as measured by RECIST criteria Phase III: Event-free survival;Timepoint(s) of evaluation of this end point: the main assessment time point for the phase II study will be at baseline and after 4 cycles of chemotherapy

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Secondary

Measure	Time frame
Secondary end point(s): Progression-free survival (PFS) Overall survival (OS) Quality of Life (QoL) Adverse events and toxicity, defined by NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0 Days spent in hospital Imaging response ;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) The outcome measure of the phase III study will be event free survival. It will be assessed at every clinic visit. The frequency and timing of clinic visits is not specified in the protocol since international practice varies. imaging: cycle 2, cycle 6 + End of trial	—

Measure

Time frame

Secondary end point(s): Progression-free survival (PFS) Overall survival (OS) Quality of Life (QoL) Adverse events and toxicity, defined by NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0 Days spent in hospital Imaging response ;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) The outcome measure of the phase III study will be event free survival. It will be assessed at every clinic visit. The frequency and timing of clinic visits is not specified in the protocol since international practice varies. imaging: cycle 2, cycle 6 + End of trial

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Countries

Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Hungary, Italy, Netherlands, Poland, Spain, United Kingdom

Contacts

Public ContactJaclyn Brown

University of Birmingham

j.brown.5@bham.ac.uk01214151060

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 22, 2026