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.

Phase 1

• Conditions: Recurrent and refractory Ewing sarcoma; MedDRA version: 27.0Level: LLTClassification code 10015567Term: Ewing's tumor localizedSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 21.1Level: LLTClassification code 10015763Term: Extra-osseous Ewing's sarcoma NOSSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 27.0Level: LLTClassification code 10015566Term: Ewing's tumorSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 27.0Level: LLTClassification code 10015762Term: Extra-osseous Ewing's sarcoma non-metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 27.0Level: LLTClassification code 10015569Term: Ewing's tumor recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 27.0Level: PTClassification code 10015761Term: Extra-osseous Ewing's sarcoma metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 27.0Level: LLTClassification code 10015568Term: Ewing's tumor metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 27.0Level: LLTClassification code 10058252Term: Ewing's tumour recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 27.0Level: LLTClassification code 10058253Term: Ewing's tumour metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

• Registration Number: EUCTR2014-000259-99-BE
• Lead Sponsor: niversity of Birmingham

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-09-04
• Last Update Posted: 15 July 2024

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 400

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)

Are the trial subjects under 18? yes
Number of subjects for this age range: 200
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 200
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The objectives of the study are to compare chemotherapy 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: N/A;Primary end point(s): Event-free survival time (EFS);Timepoint(s) of evaluation of this end point: At every clinic visit

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): • Objective imaging response (OR) according to RECIST 1.1 criteria<br>• Progression-free survival time (PFS)<br>• Overall survival time (OS)<br>• Quality of Life (QoL)<br>• Toxicity, defined by NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0<br>• PET-CT response after 4 cycles<br>• Days spent in hospital;Timepoint(s) of evaluation of this end point: • 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<br>• PFS and OS will be assessed at every clinic visit<br>• QoL will be assessed at baseline and after 2 and 4 cycles of chemotherapy<br>• PET-CT response: after 4 cycles<br>• 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<br>1-6 (other chemotherapy regimens)