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

niversity of Birmingham0 sites900 target enrollmentSeptember 7, 2023

Overview

No summary available.

Registry

who.int

Start Date

September 7, 2023

End Date

November 30, 2032

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

•Inclusion Criteria for study entry – Mandatory first point of study entry, for all patients
•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. 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

•Exclusion Criteria for study entry
•1\. Previous malignancy
•Exclusion criteria for randomisation A will be defined on completion of the externally sponsored phase 1b study. 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)