This clinical trial is focused on studying the treatment of Ewing sarcoma, a type of cancer that occurs in bones or the soft tissue around the bones. The study aims to find out if adding a maintenance treatment called VinoCyc to the standard treatment can improve the chances of staying free from cancer events for patients with this disease. The standard treatment involves a combination of medications, including Cyclophosphamide, Ifosfamide, Vincristine Sulfate, Vinorelbine, Etoposide, Doxorubicin, Anhydrous Cyclophosphamide, Mesna, and Filgrastim. These medications are used in different forms, such as tablets or injections, and are given either orally or intravenously, which means directly into a vein.
The purpose of the study is to see if the new treatment approach can increase the time patients remain free from cancer events compared to the standard treatment alone. The study will also look at whether a higher dose of radiation therapy is as safe as the standard dose in terms of skin side effects. Patients will receive a series of treatment cycles, and some may receive a placebo, which is a substance with no active medication, to compare the effects of the new treatment.
Throughout the study, patients will be monitored for their overall survival, which means the length of time they live after starting the treatment, as well as their quality of life. The study will also explore other factors like the biology of Ewing sarcoma and how quickly the disease is diagnosed. The trial is expected to continue until 2031, with the goal of improving treatment outcomes for patients with this type of cancer.
1initial assessment
Upon joining the trial, an initial assessment is conducted to confirm eligibility. This includes a review of medical history and a series of tests to ensure all criteria are met.
Tests may include blood tests to check white blood cell count, cardiac function tests, and a pregnancy test for those of childbearing potential.
2treatment phase
The treatment phase involves receiving medications designed to treat Ewing sarcoma. The medications include cyclophosphamide, ifosfamide, vincristine sulfate, vinorelbine, etoposide, doxorubicin, and mesna.
These medications are administered either orally or through intravenous (IV) infusion. The specific dosage and frequency will be determined by the medical team based on individual needs.
The treatment is divided into cycles, with each cycle lasting a few weeks. The total number of cycles will depend on the specific part of the trial you are participating in.
3maintenance treatment
After completing the initial treatment cycles, some patients may receive a maintenance treatment using a combination of vinorelbine and cyclophosphamide (referred to as VinoCyc).
This phase aims to improve event-free survival, which means extending the time without the cancer returning or worsening.
4follow-up and monitoring
Regular follow-up visits are scheduled to monitor health and response to treatment. These visits may include physical exams, imaging tests, and blood tests.
The follow-up period is crucial for assessing the long-term effects of the treatment and ensuring any side effects are managed effectively.
5end of trial
The trial concludes with a final assessment to evaluate the overall outcomes and any lasting effects of the treatment.
Participants may be asked to provide feedback on their experience to help improve future studies.
Who Can Join the Study?
Must have a confirmed diagnosis of Ewing Sarcoma or a similar type of cancer called Ewing-like sarcoma, which affects bones or soft tissues. This diagnosis can be done at the study site.
Can be of any sex and must be older than 2 years and younger than 50 years at the time of the diagnostic biopsy.
Must provide informed consent, which means agreeing to participate in the study after understanding all the details. This consent must be given before starting any study-related activities. If applicable, a parent or legal representative must also provide consent.
Must be willing and able to attend scheduled visits and follow the study procedures.
Must have a white blood cell (WBC) count greater than 2000 per microliter. White blood cells are important for fighting infections.
Must have a heart function assessment showing a left ventricular ejection fraction (LVEF) greater than 40% and a shortening fraction (SF) greater than 28%. These are measures of how well the heart is pumping blood.
Must have a serum creatinine level less than 1.5 times the upper limit of normal. Creatinine is a waste product in the blood that indicates how well the kidneys are working.
If of childbearing potential, must have a negative pregnancy test before joining the study and every month during treatment. Both female and male participants who are fertile and sexually active must agree to use effective contraception from the time of consent until 6 months after treatment ends.
Who Cannot Join the Study?
Patients who have a different type of cancer other than Ewing Sarcoma.
Patients who are not within the specified age range for the study.
Patients who are not able to follow the study procedures or instructions.
Patients who have other serious health conditions that could interfere with the study.
Patients who are pregnant or breastfeeding.
Patients who have participated in another clinical trial recently.
Patients who are unable to provide informed consent or do not have a legal guardian to do so on their behalf.
VinoCyc is a medication being tested in this trial to see if it can help improve the chances of staying free from cancer events for patients with Ewing sarcoma. It is used as a maintenance treatment, which means it is given after the initial treatment to help keep the cancer from coming back. The trial is looking at whether adding VinoCyc to the standard treatment can increase the time patients remain free from cancer events.
VDC/IE is a combination of medications that is part of the standard treatment for Ewing sarcoma. This combination is used to treat the primary disease and involves several cycles of treatment. The trial is comparing the standard VDC/IE treatment with and without the addition of VinoCyc to see if the new approach can improve patient outcomes.
Ewing Sarcoma – Ewing Sarcoma is a type of cancer that occurs in bones or in the soft tissue around the bones. It primarily affects children and young adults. The disease often begins in the long bones of the arms and legs, pelvis, or chest. As it progresses, it can cause pain, swelling, and sometimes a palpable mass. The cancer cells can spread to other parts of the body, such as the lungs or other bones. The progression of Ewing Sarcoma can vary, with some cases remaining localized while others may metastasize.
The website uses cookies to ensure the proper functioning of the site and to analyze internet traffic. Some cookies are essential for using the service and do not require consent. You can accept all cookies or use only the essential ones. Data is processed in accordance with our Privacy Policy. You have the right to withdraw your consent, access, rectify, delete, or limit the processing of your data at any time.
Austria 
Belgium 
Finland 
Germany 
Greece 
Hungary 
Poland 
Sweden 
