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Study of drug combination therapy for patients with recurrent and primary refractory Ewing Sarcoma

Verified siteRegistered drugNo placebo
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What is this trial about?

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

This clinical trial focuses on treating patients with Ewing Sarcoma that has either come back after treatment or did not respond to initial treatment. The study tests several chemotherapy medications including gemcitabine, docetaxel, irinotecan, temozolomide, topotecan, carboplatin, cyclophosphamide, ifosfamide, etoposide, and lenvatinib. The purpose is to determine which treatment combination works best in terms of effectiveness and side effects.

The treatment involves different combinations of these medications given either through an intravenous infusion into a vein or as oral capsules taken by mouth. 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 will monitor the size of tumors using imaging scans to check if the treatment is working. They will also track any side effects and how long patients stay in the hospital. The study measures how long patients live without their disease getting worse and their overall survival time. Additionally, patients' quality of life will be evaluated during the treatment period.

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

    Medical evaluation to confirm eligibility for the trial

    Baseline imaging must be completed within 4 weeks before starting the treatment

    For female patients who can become pregnant, a negative pregnancy test is required

  2. Step 2

    Treatment assignment

    Random assignment to one of the available treatment groups

    Each group receives different combinations of anti-cancer medications

  3. Step 3

    Treatment cycles

    Treatment will be administered through oral medications (pills taken by mouth) or intravenous medications (given through a vein)

    Imaging tests will be performed after 2 and 4 cycles of treatment to check response

    Some treatment groups will have additional imaging after 6 cycles

    A special imaging test called PET-CT will be done after 4 cycles

  4. Step 4

    Regular monitoring

    Regular checks of blood pressure

    Monitoring of liver function

    Assessment of kidney function

    Heart function tests for specific treatment groups

    Regular evaluation of side effects using standardized criteria

    Quality of life assessments

  5. Step 5

    Long-term follow-up

    Continued monitoring of disease status

    Recording of time without disease progression

    Tracking of overall health status

    Documentation of hospital stays

    Patients who can become pregnant must use effective birth control during treatment and for 12 months after the last treatment

Who can join the trial?

14 criteria

  • Patient must have Ewing sarcoma or Ewing-like sarcoma confirmed by tissue examination (histology) either when first diagnosed or when disease progressed
  • Patient must be at least 2 years old
  • Patient must have evidence of disease progression during or after completing treatment
  • Patient must be medically fit to receive trial treatment
  • Patient must have adequate kidney function (with GFR of 60 ml/min/1.73m2 or higher)
  • Patient must agree to use effective birth control during treatment and for 12 months after last treatment
  • Female patients who can become pregnant must have a negative pregnancy test
  • Patient and/or parent/legal guardian must provide written informed consent
  • Imaging tests must be done within 4 weeks before starting the trial
  • For patients receiving specific treatment (IFOS/IFOS-L):
    • Liver function tests must be within certain limits
    • Heart function must show ejection fraction of 50% or higher
    • Blood pressure must be adequately controlled
    • Protein levels in urine must be within acceptable limits
    • Patient must be eligible for at least two treatment options in the study

Who cannot join the trial?

11 criteria

  • Patients who have not been diagnosed with Ewing Sarcoma (a type of bone or soft tissue cancer)
  • Patients younger than 6 years old or older than 65 years of age
  • Patients who have not experienced cancer recurrence (return of cancer) or have not shown resistance to initial treatment
  • Patients who cannot undergo systemic therapy (treatment that affects the entire body, such as chemotherapy)
  • Patients who are unable to complete imaging tests needed to monitor treatment response
  • Patients who are unable to provide informed consent or whose legal guardian cannot provide consent
  • Patients with severe medical conditions that would make participation unsafe
  • Patients currently participating in other clinical trials that could interfere with this study
  • Patients who are pregnant or breastfeeding
  • Patients with known allergies or sensitivities to the study medications
  • Patients who cannot comply with the study requirements or follow-up visits
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Investigated drugs

  • Gemcitabine

    is a chemotherapy drug given through an IV. It works by stopping cancer cells from making DNA, which helps slow or shrink the tumor. In this trial it is used as part of the treatment plan for patients whose Ewing sarcoma has come back or did not respond to earlier therapy.

  • Lenvatinib

    (sold as Lenvima) is a pill taken by mouth. It blocks signals that tumors need to grow new blood vessels, which can limit the tumor’s ability to get nutrients. The study tests this drug as an oral option to see if it helps control recurrent or resistant Ewing sarcoma.

  • Temozolomide

    is a chemotherapy tablet taken by mouth. It damages the DNA of cancer cells, making it harder for them to multiply. In the trial it is combined with other drugs to try to improve outcomes for patients whose disease has returned or did not respond to previous treatment.

  • Ifosfamide

    is given by IV and belongs to a group of chemotherapy agents that interfere with the DNA of cancer cells. It is used in the study to see how well it works, alone or with other medicines, in controlling difficult‑to‑treat Ewing sarcoma.

  • Docetaxel

    (including the anhydrous form) is an IV chemotherapy drug that stops cancer cells from dividing by affecting their internal skeleton. The trial includes this medication to evaluate its effectiveness and safety for patients with recurrent or refractory disease.

  • Carboplatin

    is an IV chemotherapy agent that damages the DNA of cancer cells, leading to cell death. It is tested in the study as part of combination regimens aimed at improving response in Ewing sarcoma that has come back or did not respond to earlier therapy.

What is already known about the treatment

  • Gemcitabine

    Given by intravenous infusion, gemcitabine is an approved cancer drug used for cancers such as pancreatic, lung and breast and is being studied for Ewing sarcoma; it is a nucleoside analog that is taken up by cells and turned into a fake DNA building block, stopping DNA replication and causing cell death; its main therapeutic indication is as a chemotherapy agent for solid tumors; it belongs to the class of antimetabolite chemotherapies.

  • Lenvatinib

    Taken orally in hard‑capsule form, lenvatinib is an approved multi‑kinase inhibitor for thyroid, liver and kidney cancers and is being explored for sarcoma treatment; it blocks several growth‑factor receptors that tell cancer cells to grow and form new blood vessels; its primary indication is targeted therapy for advanced solid tumors; it is classified as a tyrosine‑kinase inhibitor.

  • Temozolomide

    Administered as oral capsules, temozolomide is an approved drug for brain tumors such as glioblastoma and is sometimes used off‑label for sarcoma; once inside the body it is converted to a compound that adds methyl groups to DNA, which damages the DNA and triggers cancer‑cell death; its main use is as an alkylating chemotherapy for malignant brain tumors; it belongs to the alkylating agent class.

  • Ifosfamide

    Given by intravenous infusion, ifosfamide is an approved chemotherapy for soft‑tissue sarcoma and other cancers and is included in many sarcoma regimens; it is a nitrogen‑mustard type drug that adds alkyl groups to DNA, preventing the cancer cells from dividing; its primary indication is as a systemic anticancer agent; it is classified as an alkylating agent.

  • Docetaxel

    Delivered through an intravenous infusion, docetaxel (including its anhydrous form) is an approved chemotherapy for breast, lung and prostate cancers and is used in sarcoma trials; it works by stabilizing microtubules, which stops cells from pulling apart during division and leads to cell death; its main therapeutic use is as a taxane‑type chemotherapy for solid tumors; it belongs to the taxane class of antimitotic agents.

  • Carboplatin

    Administered intravenously, carboplatin is an approved platinum‑based chemotherapy for ovarian, lung and other cancers and is part of combination regimens for sarcoma; it creates cross‑links in DNA that block the DNA from being copied, causing cancer cells to die; its primary indication is as a systemic cytotoxic drug for solid tumors; it is classified as a platinum compound.

Investigated diseases

Ewing Sarcoma - A rare type of cancer that forms in bone or soft tissue, typically affecting children and young adults. The disease usually develops in the bones, particularly the pelvis, chest wall, legs, or arms. It can spread to other parts of the body, especially to the lungs and other bones. Ewing sarcoma causes pain and swelling in the affected area, and may also lead to general symptoms such as fever and fatigue. The condition tends to be aggressive in its growth pattern and can recur after initial treatment.
Trial detailsLast updated 21 Oct 2026
Age18+ yearsPhasePhase IVTrial ID2024-516078-31-00Protocol codeRG_13-277Estimated enrolment712 patientsSponsorThe University Of Birmingham

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