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Study on Ewing Sarcoma Treatment with Vinorelbine and Drug Combination for Patients with Primary and Disseminated Disease

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What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial 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.

  2. Step 2

    Treatment 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.

  3. Step 3

    Maintenance 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.

  4. Step 4

    Follow-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.

  5. Step 5

    End 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 trial?

8 criteria

  • 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 trial?

7 criteria

  • 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.
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Investigated drugs

  • 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.

What is already known about the treatment

VinoCyc – VinoCyc is administered as a maintenance treatment in the form of an intravenous infusion, which means it is given directly into the bloodstream through a vein. It is currently being studied in clinical trials for its effectiveness in improving event-free survival in patients with Ewing sarcoma, a type of bone cancer. The main therapeutic indication for VinoCyc is to enhance the outcomes of standard chemotherapy regimens. At the molecular level, VinoCyc works by interfering with the cancer cells' ability to divide and grow, ultimately leading to their death. It is classified pharmacologically as a chemotherapeutic agent.

Investigated diseases

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.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2022-501180-40-00Protocol codeiEuroEwingEstimated enrolment1 424 patientsSponsorGPOH gGmbH

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).