A groundbreaking new international clinical trial has been funded for Ewing sarcoma patients. INTER-EWING-1 is expected to start recruiting UK patients in 2023 and is being led by Bone Cancer Research Trust Trustee and world-renowned Consultant Paediatric Oncologist, Professor Bernadette Brennan.
INTER-EWING-1 builds on Euro Ewing 2012, a previous clinical trial which concluded in 2019. Euro Ewing 2012 identified VDC/IE as the new standard chemotherapy for newly diagnosed Ewing sarcoma patients. It was a very efficient trial that managed to answer the question posed within 5 years. However, new drugs were not available at the time and many aspects were not investigated; for example, a true evaluation of the effect of radiotherapy before and after surgery and the use biomarkers and imaging to facilitate prognosis, staging, disease monitoring and response to treatment. INTER-EWING-1 will now look at some of these aspects.
INTER-EWING-1 will take place in Australia, New Zealand, Italy, France, Netherlands, Norway, Poland, Israel, Denmark, and the UK.
In the UK, the trial has been fully funded by Cancer Research UK and will be led by Professor Bernadette Brennan. The trial aims to recruit 900 newly diagnosed Ewing sarcoma patients across Europe. Professor Brennan said:
This truly international trial offers the opportunity to investigate a new drug for Ewing sarcoma patients with metastatic disease, in addition, the INTER-EWING-1 trial plans to determine the optimal doses for radiotherapy and the benefit of an additional treatment round, a so-called maintenance treatment. We expect the study to be open next year and recruiting the first patients.
Key aims of INTER-EWING-1:
- The introduction of a new multiple tyrosine kinase inhibitor drug (regorafenib) into current standard chemotherapy regime in metastatic Ewing sarcoma.
- Determination of the optimal dose and benefit of radiotherapy as local therapy to the primary tumour site.
- Determination of the optimal dose and benefit of post-operative radiotherapy.
- The addition of maintenance treatment (vinorelbine + cyclophosphamide vs end of treatment) and evaluate its potential to reduce relapse.
In addition, several biomarkers that can be found in the blood of Ewing sarcoma patients, as well as imaging techniques will be evaluated to facilitate staging, response to treatment and disease monitoring. These can have a pronounced effect in improving the quality of life of patients, as they are so much less invasive.
Dr Zoe Davison, Bone Cancer Research Trust, said:
We are delighted to see Cancer Research UK invest over £3 million into primary bone cancer research through INTER-EWING-1. This will be the first time that a new drug is being given upfront in first line treatment and not in a relapse setting.
This signifies a huge step forward in treatment for Ewing sarcoma patients. Our hope is that survival rates and quality of life for patients will be improved by this exciting and innovative trial.
We will continue to monitor the progress of INTER-EWING-1 and update the primary bone cancer community on progress made. The Bone Cancer Research Trust is supporting INTER-EWING-1 and all primary bone cancer-benefiting clinical trials through our newly launched Clinical Trials Top-up Scheme which has been developed to supplement trials to ensure maximum patient benefit is achieved. The scheme is available now for researchers to apply and support:
- Aligned biological studies
- Additional arms or research questions (observational or interventional)
- Toxicology studies
For more details on the Clinical Trials Top-up Scheme, click below.