rEECur: Chemotherapy for the treatment of recurrent and primary refractory Ewing sarcoma

Phase 2

Recruiting

• Conditions: Ewing Sarcoma; Cancer - Children's - Other; Cancer - Bone

• Registration Number: ACTRN12618001825246
• Lead Sponsor: niversity of Birmingham

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-11-09
• Last Update Posted: 21 May 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 600

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 greater than or equal to 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. Adequate GFR

IFOS-Lenvatinib specific principal inclusion criteria:
1. Adequate liver function
2. Left ventricular ejection fraction greater than or equal to 50% at baseline as determined by echocardiography.
3. Normal or adequately controlled blood pressure (BP)

Exclusion Criteria

1.Absolute Neutrophil Count (ANC) <1.0 x 10^9/L or platelets <75 x 10^9/L.
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

IFOS-Lenvatinib specific principal exclusion criteria:
1. Significant proteinuria
2. Arterial Thromboembolism in previous 6 months
3. Gastrointestinal bleeding or active haemoptysis within previous 3 weeks
4. Major surgery within previous 3 weeks
5. Previous treatment with tyrosine kinase inhibitors

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Event-free survival which is defined as the time from randomisation until the first event (progression, recurrence following response, secondary malignancy or death).<br><br>The primary outcome measure 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.[ The main assessment time point for the phase II study will be at baseline and after 4 cycles of chemotherapy. Additional imaging will be performed after 2 and 6 cycles of chemotherapy.<br><br>];Phase III: Event-free survival which is defined as the time from randomisation until the first event (progression, recurrence following response, secondary malignancy or death). [ The outcome measure of the phase III 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.]