International Randomised Controlled Trial of Chemotherapy for the Treatment of Recurrent and Primary Refractory Ewing Sarcoma
- Conditions
- Ewing Sarcoma10028389
- Registration Number
- NL-OMON55584
- Lead Sponsor
- Iniversity of Birmingham
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 6
- 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 oftreatment.
- 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)
- 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
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Event-free survival (EFS)</p><br>
- Secondary Outcome Measures
Name Time Method