Clinical Trials for Extra-osseous Ewing’s Sarcoma
There is currently 1 ongoing clinical trial for patients with Extra-osseous Ewing’s sarcoma (also known as Ewing’s sarcoma). This trial is testing different combinations of chemotherapy medications for patients whose disease has returned after treatment or did not respond to initial treatment. The study is being conducted across multiple European countries including Finland, Denmark, Italy, France, Spain, Austria, Norway, Netherlands, Belgium, and Czechia.
Clinical trial locations
- Austria
- Belgium
- Czechia
- Denmark
- Finland
- France
- Italy
- Netherlands
- Norway
- Spain
Study of drug combination therapy for patients with recurrent and primary refractory Ewing Sarcoma
This clinical trial is designed for patients whose Ewing sarcoma has either returned after previous treatment or did not respond to the first round of therapy. The study aims to identify which combination of chemotherapy medications works best for these difficult-to-treat cases.
Who can participate: To be eligible for this trial, patients must meet several requirements. They must have their diagnosis confirmed through tissue examination, either at the time of initial diagnosis or when the disease progressed. Participants need to be at least 2 years old and have evidence that their disease has progressed during or after completing treatment. The trial requires that patients are medically fit enough to receive the treatment and have adequate kidney function, with a GFR of 60 ml/min/1.73m² or higher. Additionally, imaging tests must be completed within 4 weeks before starting the trial, and patients must be eligible for at least two of the treatment options being studied. For female patients who can become pregnant, a negative pregnancy test is required, and all participants must agree to use effective birth control during treatment and for 12 months afterward. Written informed consent from the patient or their parent or legal guardian is also necessary.
Who cannot participate: Several conditions exclude patients from this trial. Those who are younger than 6 years old or older than 65 years of age cannot participate. The trial is not suitable for patients who cannot undergo chemotherapy that affects the entire body, cannot complete the required imaging tests, or are unable to provide informed consent. Patients with severe medical conditions that would make participation unsafe are excluded, as are those currently participating in other clinical trials that could interfere with this study. Pregnant or breastfeeding patients cannot join, nor can those with known allergies to the study medications or those who cannot comply with study requirements or follow-up visits.
What the trial involves: The study tests several chemotherapy medications including gemcitabine, docetaxel, irinotecan, temozolomide, topotecan, carboplatin, cyclophosphamide, ifosfamide, etoposide, and lenvatinib. Patients are randomly assigned to one of several treatment groups, each receiving different combinations of these medications. The treatments are given either as pills taken by mouth or through an intravenous infusion into a vein. Some medications are given daily while others are administered on specific days during treatment cycles that typically last several weeks. The total treatment duration may continue for up to 104 weeks, depending on how well the treatment works.
Throughout the study, doctors carefully monitor patients with imaging scans after 2 and 4 cycles of treatment to check if the tumors are responding. Some treatment groups receive additional imaging after 6 cycles, and a special PET-CT scan is performed after 4 cycles. Regular monitoring includes checking blood pressure, liver function, kidney function, and heart function for specific treatment groups. Side effects are tracked using standardized criteria, and patients’ quality of life is assessed throughout the treatment period. The study measures how long patients live without their disease getting worse, their overall survival time, and how long they stay in the hospital.
Summary
Currently, there is one active clinical trial for patients with Extra-osseous Ewing’s sarcoma who face particularly challenging situations where their disease has returned or did not respond to initial treatment. This international trial offers hope by testing multiple combinations of chemotherapy medications to determine which approaches are most effective. The study is notable for its wide geographic reach across 10 European countries, making it accessible to many patients across the continent. The trial focuses on comparing different chemotherapy combinations including gemcitabine, lenvatinib, temozolomide, and several other established cancer medications. Patients interested in participating should discuss eligibility requirements with their healthcare team, particularly regarding age restrictions, kidney function, and overall health status.
