INTER-EWING-1
Research type
Research Study
Full title
International clinical research programme to improve outcomes in newly diagnosed Ewing sarcoma – Trial 1 (INTER-EWING-1)
IRAS ID
1005108
Contact name
Bernadette Brennan
Contact email
Sponsor organisation
University of Birmingham
Eudract number
2021-005061-41
Research summary
Ewing Sarcoma is a cancer of bone or soft tissue that occurs in children and adults. Treatment usually includes chemotherapy, surgery and/or radiotherapy. Many patients can be cured with this combination; however, survival rates are lower if the tumour has spread to other areas of the body and/or does not respond to initial treatment, or comes back. INTER-EWING-1 is an international clinical trial open to patients of all ages , which aims to answer the following key questions:
• Does giving an extra drug (in addition to standard treatment) improve survival for patients where their disease has spread?
• How long should chemotherapy be given – does giving a longer period of less intensive chemotherapy at the end of standard treatment improve survival?
• For patients whose tumour cannot be removed with surgery, do higher doses of radiotherapy reduce the risk of the tumour coming back?
• Where the tumour is known to be more likely to come back after an operation (for example, if the tumour is large, or does not respond to chemotherapy), can lower doses of radiotherapy reduce the side effects but not increase the risk of the tumour coming back?
In INTER-EWING-1, we want to find if having standard chemotherapy plus a type of drug designed to target tumour cells, called a multi-tyrosine kinase inhibitor (MTKI) is better for patients. The MTKI regorafenib will be given to patients who have tumours which have spread to other parts of the body. As this is the first time patients will have been given this combination, initial safety testing will be done in a separate study first.
In some other cancers, continuing low dose chemotherapy at the end of standard treatment has been shown to improve survival. In INTER-EWING-1 we want to find if having an additional 6 months of chemotherapy is better for patients or not.
Outcomes for patients after failure to control disease are very poor. INTER-EWING-1 aims to optimise the radiotherapy doses given to achieve best outcomes.REC name
East of England - Cambridge South Research Ethics Committee
REC reference
23/EE/0023
Date of REC Opinion
19 Jul 2023
REC opinion
Further Information Favourable Opinion