A new international clinical trial, INTER-EWING-1, is underway to explore improved treatment strategies for Ewing sarcoma, a rare bone cancer primarily affecting children and young adults. The trial, led by the University of Birmingham’s Cancer Research UK Clinical Trials Unit (CRCTU), aims to enhance the effectiveness of current treatments, which typically include chemotherapy, surgery, and radiotherapy.
The INTER-EWING-1 trial is set to run until November 2032 and will recruit approximately 900 participants internationally across Europe and Australasia. Initially, all patients will receive extra scans or maintenance chemotherapy, with research investigating radiotherapy benefits added in 2025. One key aspect of the trial is the introduction of regorafenib, a drug being trialed as a frontline treatment in combination with chemotherapy.
Professor Bernadette Brennan, Paediatric Oncologist at RMCH and study lead, said: “Treatments for Ewing sarcoma have not changed much over the past 30 years so more research in this field is vital, and I am proud to be leading this important study at RMCH and internationally.”
Trial Design and Objectives
The INTER-EWING-1 trial has multiple aims, including determining if the addition of regorafenib improves the effectiveness of chemotherapy. Researchers also seek to identify the optimal dose of radiotherapy and evaluate the benefit of additional cycles of maintenance chemotherapy to prevent cancer recurrence. Furthermore, the study will investigate how radiological scans can help predict a patient's response to treatment.
The Need for Improved Treatments
While approximately 60% of individuals with bone cancer survive at least five years post-diagnosis, survival rates are lower when the cancer has spread. The INTER-EWING-1 trial represents a crucial step towards developing personalized treatments to improve outcomes for Ewing sarcoma patients globally.
Dr Laura Danielson, Research Lead for Children and Young People's Cancer at Cancer Research UK, said: "The INTER-EWING-1 trial is a crucial opportunity to change the outlook for children and young people with Ewing sarcoma. Not only does it focus on improving current treatments, but it also introduces regorafenib, a new drug to be trialled as a frontline treatment for this type of cancer."
Patient Involvement
Royal Manchester Children’s Hospital (RMCH) has already recruited the first patient globally to the INTER-EWING-1 study. Eleven-year-old Harvey, diagnosed with Ewing sarcoma in June 2024, is participating in the study, which involves extra scans and x-rays. His father, James, emphasized the importance of the research, stating, “When we considered that we could potentially help other children and other families in similar situations, the decision to take part was a simple one.”