Ewing Sarcoma (ES) is a rare cancer of the bone and soft tissue that is most commonly diagnosed in adolescents and young adults. Current treatment protocols involve chemotherapy, surgery and/ or radiotherapy, which produces a 5-year survival rate 65-75%. There is a possibility of life-long side effects, including further disease. Patients that are diagnosed when the cancer has already spread (metastasised) or have experienced a recurrence of their disease have a much lower chance of survival.
This study will examine if changing treatment at three key points can improve survival for patients diagnosed with ES. These changes are:
1. Combining a new drug (regorafenib) with chemotherapy
2. Refining radiotherapy treatment/doses
3. Adding further chemotherapy at the end of treatment.
Ewing Sarcoma is a cancer of bone or soft tissue that occurs in children and adults. Treatment usually includes chemotherapy, surgery and/or radiation therapy. This is an international clinical trial (INTER-EWING-1) that will assess multple combinations of these treatment types to determine whether different combinations are better able to improve survival for people with Ewing Sarcoma.
Eligible participants may enter into one of three different treatment arms, depending upon which inclusion criteria they meet. A researcher will assess eligible participants to determine which treatment arm they are most suitable for, and patients will then be randomly allocated by chance into one of two groups for that treatment arm.
Treatment Group A will receive a new chemotherapy drug over 9 cycles.
Treatment Group B will receive doses of radiation therapy which may differ depending upon whether they are able to undergo surgical removal of their cancer or not. Participants will be asked to attend a maximum of 36 sessions over 7.2 weeks.
Treatment Group C will receive either additional doses of a currently used chemotherapy drug, or will be asked to stop their treatment after the standard treatment cycles have been given.
If participants are eligible fo rmore than one of these treatment groups they can choose to enrol in a second and then third treatment group once they have completed their first allocated treatment.