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Clinical Trials/ACTRN12624000532505
ACTRN12624000532505Not yet recruitingPhase 3

International clinical research programme to improve outcomes in newly diagnosed Ewing sarcoma – Trial 1 (INTER-EWING-1)

niversity of Birmingham0 sites900 target enrollmentStarted: April 29, 2024Last updated:
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Conditions

Trial Snapshot

Phase
Phase 3
Status
Not yet recruiting
Enrollment
900
Study OverviewStudy DesignEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional
Allocation
Randomised controlled trial
Primary Purpose
Treatment
Masking
Open (masking not used)

Eligibility Criteria

Ages
2 Years to o limit (—)
Sex
All

Inclusion Criteria

  • •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
  • •2. Age > 2 years
  • •3. Written informed consent from the patient and/or the parent/legal guardian
  • •inclusion criteria for randomisation A will be defined on completion of the externally sponsored phase 1b study (ClinicalTrials.gov Identifier: NCT05830084, EudraCT No: 2022-002874-10). A substantial amendment will be submitted to the relevant competent authority and ethics committee(s) to include these details prior to the opening of Randomisation A.
  • •Radiotherapy Randomisations – B1 and B2
  • •Inclusion Criteria
  • •1. Entered into the INTER-EWING-1 study
  • •2. Received induction/consolidation chemotherapy with a VDC/IE/VC based regimen
  • •3. Patient assessed as medically fit to receive the radiotherapy
  • •4. Documented negative pregnancy test for female patients of childbearing potential
  • •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
  • •6. Written informed consent from the patient and/or the parent/legal guardian
  • •Randomisation B1 specific Inclusion criteria– Definitive radical radiotherapy dose finding randomisation
  • •1. Patients requiring definitive radical radiotherapy to primary tumour site as sole local therapy following discussion by local multidisciplinary team.
  • •2. Patients who have undergone an R2 resection of the primary tumour (macroscopic residual tumour), requiring definitive radical radiotherapy
  • •Randomisation B2 specific Inclusion criteria– Post-operative radiotherapy dose finding randomisation
  • •1. Patients requiring post-operative radiotherapy following discussion by local multidisciplinary team
  • •according to multidisciplinary team meeting.
  • •Randomisation C – Maintenance chemotherapy randomisation
  • •Inclusion Criteria
  • •1. Entered into the INTER-EWING-1 study
  • •2. Received induction/ consolidation chemotherapy with a VDC/IE/VC based regimen
  • •3. Have responded to induction treatment and not progressed
  • •4. Medically fit to receive treatment
  • •5. Absence of severe vincristine neuropathy – i.e. requiring discontinuation of vincristine treatment
  • •6. Adequate liver function: bilirubin <3 x ULN and ALT or AST < 5 x ULN
  • •7. Documented negative pregnancy test for female patients of childbearing potential
  • •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
  • •9. Written informed consent from the patient and/or the parent/legal guardian

Exclusion Criteria

  • •1. Previous malignancy
  • •Exclusion criteria for randomisation A will be defined on completion of the externally sponsored phase 1b study (ClinicalTrials.gov Identifier: NCT05830084, EudraCT No: 2022-002874-10). A substantial amendment will be submitted to the relevant competent authority and ethics committee(s) to include these details prior to the opening of Randomisation A.
  • •Exclusion Criteria Radiotherapy Randomisations – B1 and B2
  • •1. Previous radiotherapy to the same site
  • •2. Pregnant or breastfeeding women
  • •3. BuMel high dose chemotherapy within previous 10 weeks
  • •Randomisation B1 specific Exclusion criteria– Definitive radical radiotherapy dose finding randomisation
  • •1. Patients who have had a R1 or R0 surgical resection of their tumour
  • •2. Previous high dose chemotherapy including busulfan when specified dose constraints to critical organs cannot be met (please see INTER-EWING-1 Quartet RTQA guidelines for more details)
  • •Randomisation B2 specific Exclusion criteria– Post-operative radiotherapy dose finding randomisation
  • •1. R2 resection (macroscopic residual tumour)
  • •2. Patients treated by surgery with wide resection (R0 and all tissues involved by the prechemotherapy
  • •tumour volume have been completely resected), good histological response (< 10% viable cells), small tumour volume (< 200 mls at diagnosis), of the limb.
  • •Randomisation C – Maintenance chemotherapy randomisation
  • •Exclusion Criteria
  • •1. Urinary outflow obstruction that cannot be relieved prior to starting treatment
  • •2. Uncontrolled significant inter-current illness or active infection
  • •3. Active inflammation of the urinary bladder (cystitis)
  • •4. Known contraindication or hypersensitivity to any of the treatments or excipients
  • •5. Pregnant or breastfeeding women

Investigators

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