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.

Phase 1

• Conditions: Recurrent and refractory Ewing sarcoma; MedDRA 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: 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: 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: 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 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-FI
• Lead Sponsor: niversity of Birmingham

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-01-08
• Last Update Posted: 24 June 2024

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 525

Inclusion Criteria

1. Histologically confirmed Ewing or Ewing-like sarcoma of the bone or soft tissues. Histological confirmation either at initial diagnosis or disease progression.
2. Radiological evidence of disease progression during or after completion of first or any subsequent line of treatment.
3. Age = 2 years.
4. Eligible for randomisation between at least two open study arms.
5. Patient assessed as medically fit to receive trial treatment
6. Date of planned randomisation within 4 weeks of baseline imaging.
7. Documented negative pregnancy test for female patients of childbearing potential.
8. Patient agrees to use effective contraception during therapy and for 12 months after last trial treatment, where applicable.
9. Written informed consent from the patient and/or parent/legal guardian.
10. For the IFOS-lenvatinib arm: 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: 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) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

1. For the IFOS.-lenvatib arm: 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
2. Cytotoxic chemotherapy or other investigational medicinal product (IMP) within previous 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

Study & Design

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