In short
There are currently 2 clinical trials underway for patients with recurrent Ewing's sarcoma. These studies are testing different treatment approaches for cancers that have returned after initial treatment or have not responded to standard therapies. Trials are being conducted across multiple European countries, offering patients access to innovative treatment combinations and new medications aimed at controlling disease progression and improving quality of life.
Clinical trial locations
- Austria
- Belgium
- Czechia
- Denmark
- Finland
- France
- Italy
- Netherlands
- Norway
- Poland
- Spain
Study of drug combination therapy for patients with recurrent and primary refractory Ewing Sarcoma
This trial focuses on treating patients whose cancer has either returned after initial treatment or did not respond to the first round of therapy. The study tests several different chemotherapy medications including gemcitabine, docetaxel, irinotecan, temozolomide, topotecan, carboplatin, cyclophosphamide, ifosfamide, etoposide, and lenvatinib. The goal is to determine which combination of these medications works best while causing the fewest side effects.
Main inclusion criteria:
- Confirmed diagnosis of Ewing sarcoma or Ewing-like sarcoma through tissue examination
- Age of at least 2 years
- Evidence that the disease has progressed during or after completing treatment
- Adequate kidney function with a GFR of 60 ml/min/1.73m² or higher
- Imaging tests completed within 4 weeks before starting the trial
- For female patients who can become pregnant, a negative pregnancy test is required
- Agreement to use effective birth control during treatment and for 12 months after the last treatment
- Eligibility for at least two treatment options in the study
Main exclusion criteria:
- Patients younger than 6 years or older than 65 years
- Patients who have not experienced cancer recurrence or resistance to initial treatment
- Patients who cannot undergo systemic therapy
- Patients unable to complete required imaging tests
- Severe medical conditions that would make participation unsafe
- Pregnancy or breastfeeding
- Known allergies to the study medications
- Current participation in other conflicting clinical trials
Treatment approach: Patients will be randomly assigned to one of several treatment groups, each receiving different combinations of the medications mentioned above. Some medications are given through a vein (intravenously) while others are taken as oral capsules. Treatment cycles typically last several weeks and may continue for up to 104 weeks depending on how well the treatment is working. Throughout the study, doctors will use imaging scans to monitor tumor size and track any side effects. The study will measure how long patients live without their disease getting worse, their overall survival time, and their quality of life during treatment.
Study on the Effectiveness and Safety of Regorafenib for Patients with Resistant Primary Bone Tumors
This trial is evaluating a medication called regorafenib for patients with bone tumors that have not responded to previous treatments. Regorafenib works by blocking certain proteins that help cancer cells grow and spread, potentially slowing down or stopping tumor progression. The medication is taken orally as a film-coated tablet.
Main inclusion criteria:
- Age between 9 and 21 years at the time of joining the study
- Confirmed diagnosis of Ewing's sarcoma or osteosarcoma through microscopic tissue examination
- Evidence of treatment failure (cancer did not respond to previous treatments or returned), identified no earlier than 30 days before starting the study treatment
- Life expectancy of at least 12 weeks from the time of signing consent
- Ability to swallow tablets
- For patients in puberty, agreement to use effective birth control during treatment and for at least 2 years after stopping treatment
Main exclusion criteria:
- Patients outside the specified age range
- Inability to follow study procedures or take the medication as required
- Other medical conditions that might interfere with the study or make participation unsafe
- Pregnancy or breastfeeding
- Simultaneous participation in another clinical trial
- Allergies or reactions to regorafenib or similar medications
Treatment approach: The dosage of regorafenib is carefully determined to achieve drug exposure similar to that recommended for adults, especially for patients aged 9 to 18 years. Throughout the study, participants undergo regular health assessments including monitoring of vital signs, laboratory tests, heart function tests (echocardiography and ECG), and evaluation of any adverse events. The study aims to determine if regorafenib can help control the disease and improve quality of life for patients with resistant bone tumors. The trial is estimated to conclude by December 31, 2025.
Summary
Two clinical trials are currently offering treatment options for patients with recurrent or treatment-resistant Ewing's sarcoma. The first study, available across 10 European countries (Finland, Denmark, Italy, France, Spain, Austria, Norway, Netherlands, Belgium, and Czechia), tests multiple chemotherapy combinations to identify the most effective approach with the fewest side effects. This multi-national trial reflects a collaborative effort to provide widespread access to innovative treatment options.
The second trial, conducted in Poland, focuses specifically on regorafenib, a medication that works differently from traditional chemotherapy by targeting proteins involved in tumor growth. This study is particularly noteworthy as it includes patients with Ewing's sarcoma as well as osteosarcoma, another type of bone tumor.
Both trials share a common goal of finding better treatments for patients whose cancer has not responded to standard therapies or has returned after initial treatment. They emphasize patient safety through regular monitoring and careful patient selection based on specific health criteria. Patients interested in participating should discuss these options with their healthcare providers to determine eligibility and suitability for either trial.
