Brief Summary
The purpose of this study is to determine which of the most commonly used chemotherapya cancer treatment that uses drugs to kill or slow the growth of cancer cells, while minimising damage to healthy cells used in recurrent and primary refractory Ewing sarcomacancer arising from bones and/or soft tissue is most beneficial.
Intervention/Treatment
- Drug: Ifosfamide
- Drug: Lenvatinib
Inclusion Criteria
- Histologically confirmed Ewing or Ewing-like sarcoma of the bone or soft tissues. Histological confirmation either at initial diagnosisthe process of identifying a disease based on signs and symptoms, patient history and medical test results or disease progression.
- Radiological evidence of disease progression during or after completion of first or any subsequent line of treatment.
- Age greater than or equal to 2 years.
- Eligible for randomisation between at least two open study arms.
- Patient assessed as medically fit to receive trial treatment.
- Date of planned randomisation within 4 weeks of baseline imagingtests that create detailed images of areas inside the body.
- Documented negative pregnancy test for female patients of childbearing potential.
- Patient agrees to use effective contraception during therapy and for 12 months after last trial treatment, where applicable.
- Written informed consenta process in which a patient receives detailed information about a procedure or treatment, including its potential risks, benefits, and alternatives. The patient then has the opportunity to understand the information and voluntarily agree to the procedure or treatment. from the patient and/or parent/legal guardian.
- Adequate GFR.
IFOS-Lenvatinib specific principal inclusion criteria:
- Adequate liver function.
- Left ventricular ejection fraction greater than or equal to 50% at baseline as determined by echocardiography.
- Normal or adequately controlled bloodthe red bodily fluid that transports oxygen and other nutrients around the body pressure (BP).