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INTER-EWING-1: International Clinical Research Programme to Improve Outcomes in Newly Diagnosed Ewing Sarcoma – Trial 1
EU CTIS ID: 2024-511989-36-00
What this study is testing
The primary objectives for this trial are related to each of the trial questions. For the chemotherapy questions, the objectives are to determine: Whether outcome in newly diagnosed metastatic ES patients can be improved with the addition of regorafenib to the standard backbone chemotherapy VDC/IE when compared with VDC/IE alone (Randomisation A) Whether the addition of 6 cycles of maintenance chemotherapy of vinorelbine and cyclophosphamide improves the outcome for patients. (Randomisation C) For the radiotherapy questions, the objectives are to determine: Whether dose escalation of radiotherapy improves the outcome in patients with inoperable disease (Randomisation B1) Which of the two post-operative radiotherapy doses following surgical resection of the primary tumour site will result in achieving optimal outcome (Randomisation B2)
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Study Entry: 1. Any histologically and genetically confirmed Ewing sarcoma of bone or soft tissue, or round cell sarcomas which are ‘Ewing’s-like’ but negative for EWSR1-Fli gene rearrangement
- Randomisation B1 & B2: 5. Patient agrees to use contraception during therapy and for 12 months after last trial treatment (females) or 6 months after last trial treatment (males), where patient is sexually active
- Randomisation B1 & B2: 6. Written informed consent from the patient and/or the parent/legal guardian
- Randomisation A: To be further defined on completion of the externally sponsored phase 1b study. substantial modification will be submitted to the relevant competent authority and ethics committee(s) to include these details prior to the opening of Randomisation A.
- Randomisation C: 1. Entered into the INTER-EWING-1 study
- Randomisation C: 2. Received induction/ consolidation chemotherapy with a VDC/IE/VC/VAI/BuMel based regimen
You likely can't join if
- Study entry: 1. Previous malignancy
- Randomisation C: 1. Urinary outflow obstruction that cannot be relieved prior to starting treatment
- Randomisation C: 2. Uncontrolled significant inter-current illness or active infection
- Randomisation C: 3. Active inflammation of the urinary bladder (cystitis)
- Randomisation C: 4. Known contraindication or hypersensitivity to any of the treatments or excipients
- Randomisation C: 5. Pregnant or breastfeeding women
See the full eligibility criteria
- Study Entry: 1. Any histologically and genetically confirmed Ewing sarcoma of bone or soft tissue, or round cell sarcomas which are ‘Ewing’s-like’ but negative for EWSR1-Fli gene rearrangement
- Randomisation B1 & B2: 5. Patient agrees to use contraception during therapy and for 12 months after last trial treatment (females) or 6 months after last trial treatment (males), where patient is sexually active
- Randomisation B1 & B2: 6. Written informed consent from the patient and/or the parent/legal guardian
- Randomisation A: To be further defined on completion of the externally sponsored phase 1b study. substantial modification will be submitted to the relevant competent authority and ethics committee(s) to include these details prior to the opening of Randomisation A.
- Randomisation C: 1. Entered into the INTER-EWING-1 study
- Randomisation C: 2. Received induction/ consolidation chemotherapy with a VDC/IE/VC/VAI/BuMel based regimen
- Randomisation C: 3. Have responded to induction treatment and not progressed
- Randomisation C: 4. Medically fit to receive treatment
- Randomisation C: 5. Absence of severe vincristine neuropathy – i.e. requiring discontinuation of vincristine treatment
- Randomisation C: 6. Adequate liver function: bilirubin <3 x ULN and ALT or AST < 5 x ULN
- Randomisation C: 7. Documented negative pregnancy test for female patients of childbearing potential
- Randomisation B1: 1. Patients requiring definitive radical radiotherapy to primary tumour site as sole local therapy following discussion by local multidisciplinary team (see INTER-EWING-1 QUARTET RTQA guidelines on factors to be considered for definitive radiotherapy). This includes patients who have undergone an R2 resection of the primary tumour (macroscopic residual tumour), requiring definitive radical radiotherapy
- Randomisation C: 8. Patient agrees to use contraception during therapy and for 12 months after last trial treatment (females) or 6 months after last trial treatment (males), where patient is sexually active (see section 5)
- Randomisation C: 9. Written informed consent from the patient and/or the parent/legal guardian
- Randomisation B2: 1. Patients requiring post-operative radiotherapy following discussion by local multidisciplinary team at the multidisciplinary team meeting
- Study Entry: 2. Age ≥ 2 years
- Study entry: 3. Written informed consent from the patient and/or the parent/legal guardian
- Randomisation B1 & B2: 1. Entered into the INTER-EWING-1 study
- Randomisation B1 & B2: 2. Received induction/consolidation chemotherapy with a VDC/IE/VC/VAI/BuMel based regimen
- Randomisation B1 & B2: 3. Patient assessed as medically fit to receive the radiotherapy
- Randomisation B1 & B2: 4. Documented negative pregnancy test for female patients of childbearing potential
- Study entry: 1. Previous malignancy
- Randomisation C: 1. Urinary outflow obstruction that cannot be relieved prior to starting treatment
- Randomisation C: 2. Uncontrolled significant inter-current illness or active infection
- Randomisation C: 3. Active inflammation of the urinary bladder (cystitis)
- Randomisation C: 4. Known contraindication or hypersensitivity to any of the treatments or excipients
- Randomisation C: 5. Pregnant or breastfeeding women
- Randomisation B1 & B2: 1. Previous radiotherapy to the same site
- Randomisation B1 & B2: 2. Pregnant or breastfeeding women
- Randomisation B1 & B2: 3. BuMel high dose chemotherapy within previous 10 weeks
- Randomisation B1: 1. Patients who have had a R1 or R0 surgical resection of their tumour
- Randomisation B1: 2. Previous high dose chemotherapy including busulfan when specified dose constraints to critical organs cannot be met
- Randomisation B2: 1. R2 resection (macroscopic residual tumour)
- Randomisation B2: 2. Patients treated by surgery with wide resection (R0 and all tissues involved by the prechemotherapy tumour volume have been completely resected) and have good histological response (< 10% viable cells), small tumour volume (< 200 mls at diagnosis), of the limb.
- Randomisation A: To be further defined on completion of the externally sponsored phase 1b study. substantial modification will be submitted to the relevant competent authority and ethics committee(s) to include these details prior to the opening of Randomisation A.
The study team makes the final eligibility decision.
Where it's taking place
- Australia
- United Kingdom
- Switzerland
- New Zealand
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Australia; United Kingdom; Switzerland; New Zealand. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.