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.
- Conditions
- Recurrent and refractory Ewing sarcomaMedDRA version: 20.0Level: PTClassification code 10015560Term: Ewing's sarcomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: PTClassification code 10015564Term: Ewing's sarcoma recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: LLTClassification code 10015569Term: Ewing's tumor recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: LLTClassification code 10058252Term: Ewing's tumour recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.1Level: PTClassification code 10015764Term: Extra-osseous Ewing's sarcoma recurrentSystem 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: 21.1Level: PTClassification code 10015761Term: Extra-osseous Ewing's sarcoma metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.1Level: LLTClassification code 10015762Term: Extra-osseous Ewing's sarcoma non-metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: LLTClassification code 10015570Term: Ewing's tumourSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
- Registration Number
- EUCTR2014-000259-99-DK
- Lead Sponsor
- niversity of Birmingham
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 700
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
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: In recurrent and refractory Ewing sarcoma, which of the most commonly used chemotherapy regimens is the best to use in future treatment with respect to tumour shrinkage, survival, side effects and acceptability to patients? <br><br>This will be assessed primarily by seeing which regimen is best at stopping tumours from growing.<br><br><br>;Secondary Objective: We will also measure overall survival, side effects, tumour shrinkage after 2, 4 and 6 cycles and at the end of treatment, quality of life and days spent in hospital. ;Primary end point(s): Event-free survival time;Timepoint(s) of evaluation of this end point: The primary outcome measure of the 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.
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Objective imaging response (OR) according to RECIST 1.1 criteria 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>? Progression-free survival time (PFS)<br>? Overall survival time (OS)<br>? Toxicity, defined by National Cancer Institute Common Terminology Criteria for Adverse Events<br>(CTCAE) v4.0 (see Appendix 2)<br>? PET-CT response after 4 cycles<br>? Quality of life (QoL)<br>? Days spent in hospital;Timepoint(s) of evaluation of this end point: 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>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)