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Study on the Effectiveness and Safety of Regorafenib for Patients with Metastatic Bone Sarcomas

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 is focused on studying the effects of a medication called regorafenib in patients with a type of cancer known as metastatic bone sarcoma. Metastatic bone sarcoma is a cancer that starts in the bones and can spread to other parts of the body. The purpose of the study is to evaluate how well regorafenib works in treating this condition and to assess its safety for patients.

Participants in the study will receive either regorafenib or a placebo, which is a substance with no active medication. The study will take place over several months, during which patients will be monitored regularly to see how their cancer responds to the treatment. This will involve various assessments, including imaging tests like MRI or CT scans, to track changes in the cancer. The study aims to determine if regorafenib can help control the cancer and improve the patients' quality of life.

Throughout the study, patients will be closely observed for any side effects or changes in their condition. The information gathered will help researchers understand the potential benefits and risks of using regorafenib for treating metastatic bone sarcoma. This research is important for developing new treatment options for patients with this challenging type of cancer.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the patient will be informed about the trial's purpose, which is to evaluate the effectiveness and safety of regorafenib in treating metastatic bone sarcomas.

    The patient will be required to provide a signed informed consent form before any study-specific procedures are conducted.

  2. Step 2

    Initial assessment

    The patient will undergo an initial assessment to confirm eligibility, which includes a review of medical history and current health status.

    Eligibility criteria include a confirmed diagnosis of CIC-rearranged sarcoma, adequate organ function, and measurable disease.

  3. Step 3

    Treatment initiation

    The patient will begin treatment with Stivarga (regorafenib) 40 mg film-coated tablets, taken orally.

    The dosage and frequency will be determined by the study protocol, and the patient will be monitored for any side effects.

  4. Step 4

    Ongoing monitoring

    Throughout the study, the patient will have regular visits for monitoring, which will include laboratory tests and imaging studies to assess the response to treatment.

    The primary goal is to evaluate the non-progression rate at specific time points, such as 8 weeks for certain sarcomas.

  5. Step 5

    Evaluation of treatment response

    The patient's response to treatment will be evaluated using criteria such as RECIST 1.1, which involves measuring changes in tumor size.

    Secondary outcomes include progression-free survival and overall survival.

  6. Step 6

    Completion of study participation

    The study is expected to continue until September 2026, but individual participation may end earlier based on the patient's response or other factors.

    Upon completion, the patient will have a final assessment to summarize the outcomes and any ongoing care needs.

Who can join the trial?

16 criteria

  • Patients must have a confirmed diagnosis of **CIC-rearranged sarcoma**, which is a type of cancer affecting either bone or soft tissue.
  • Children over 12 years old must have a **Karnofsky scale** score of 60% or higher, and children 12 years old or younger must have a **Lansky scale** score of 60% or higher. These scales measure the patient's ability to perform daily activities.
  • Patients must have normal function of the **bone marrow**, **kidneys**, and **liver**. This is shown by specific blood and urine tests that check for things like white blood cell count, platelet count, and kidney and liver function.
  • Patients must have a **life expectancy** of more than 3 months.
  • Patients must have a **performance status** of less than 2 on the **ECOG scale** or 60% or higher on the **Karnofsky scale** for adults. These scales assess how the disease affects the patient's daily life.
  • Patients must have **measurable disease**, meaning there is at least one tumor that can be accurately measured using a CT scan.
  • Patients must have had no more than three previous chemotherapy treatments for their cancer.
  • Patients must have a **body surface area** of at least 1.30 square meters. This is a way to measure body size.
  • Patients must be at least 10 years old.
  • Patients must have **disease progression**, meaning their cancer has gotten worse, as shown by recent scans.
  • Patients must not be able to have surgery or radiation that could cure their cancer.
  • Women who can have children and male patients must agree to use effective birth control during the study and for 3 months after finishing treatment.
  • Women who can have children must have a negative pregnancy test before starting the study treatment.
  • Patients or their parents/legal representatives must sign a consent form agreeing to participate in the study.
  • Patients must be willing and able to attend scheduled visits and follow the treatment plan and other study procedures.
  • Patients or their parents/legal representatives must be part of the Social Security System.

Who cannot join the trial?

7 criteria

  • Patients who have a different type of cancer than bone sarcoma cannot participate. Bone sarcoma is a type of cancer that starts in the bones.
  • Patients who are not within the specified age range for the study cannot participate. The study includes specific age groups.
  • Patients who are not able to follow the study procedures or instructions cannot participate.
  • Patients who have other serious health conditions that might interfere with the study cannot participate.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients who are currently participating in another clinical trial cannot participate.
  • Patients who have had certain treatments or medications recently that might affect the study cannot participate.
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Investigated drugs

Regorafenib is a medication being studied for its ability to treat metastatic bone sarcomas. It is being tested to see how well it can stop or slow down the growth of cancer cells in the bones. The trial aims to evaluate the effectiveness and safety of this medication in patients with this type of cancer.

What is already known about the treatment

Regorafenib – Regorafenib is administered orally in the form of tablets. It is currently being studied in clinical trials for its effectiveness and safety in treating metastatic bone sarcomas. The main therapeutic indication for regorafenib is its potential use in cancer treatment, specifically targeting bone sarcomas. At the molecular level, regorafenib works by inhibiting multiple protein kinases, which are involved in tumor growth and the development of blood vessels that supply the tumor. It is classified pharmacologically as a multikinase inhibitor.

Investigated diseases

  • Osteosarcoma

    Osteosarcoma is a type of bone cancer that typically starts in the long bones, such as those in the arms and legs. It often occurs in teenagers and young adults. The disease progresses as cancer cells grow and form a tumor, which can weaken the bone and cause pain or fractures. Over time, the cancer may spread to other parts of the body, such as the lungs. The growth of the tumor can lead to swelling and reduced movement in the affected limb.

  • Ewing Sarcoma

    Ewing sarcoma is a rare cancer that occurs in bones or the soft tissue around the bones, primarily affecting children and young adults. It usually begins in the legs, pelvis, or chest wall. The disease progresses as the tumor grows, potentially causing pain, swelling, and fever. As it advances, Ewing sarcoma can spread to other areas, including the lungs and other bones. The tumor's growth can lead to significant discomfort and impact physical activity.

  • CIC-rearranged Sarcoma

    CIC-rearranged sarcoma is a rare and aggressive type of cancer that can occur in various tissues, including bones and soft tissues. It is characterized by specific genetic changes involving the CIC gene. The disease progresses with the formation of tumors that can grow rapidly and spread to other parts of the body. Symptoms may include pain, swelling, and reduced function in the affected area. The aggressive nature of this sarcoma often leads to early metastasis.

  • Chondrosarcoma

    Chondrosarcoma is a cancer that forms in cartilage cells, often affecting the pelvis, thigh, and shoulder. It is more common in adults and can vary in aggressiveness. The disease progresses as the tumor grows, potentially causing pain and swelling in the affected area. Unlike other bone cancers, chondrosarcoma is less likely to spread to other parts of the body. The tumor's growth can lead to bone damage and impact mobility.

  • Chordoma

    Chordoma is a rare type of cancer that occurs in the bones of the spine and the base of the skull. It develops from remnants of the notochord, a structure present during embryonic development. The disease progresses slowly, with tumors growing and potentially pressing on nearby nerves and tissues. This can lead to pain, neurological symptoms, and difficulty with movement. Chordomas are known for their local invasiveness rather than spreading to distant sites.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-513455-33-00Protocol codeUC-0150/1309Estimated enrolment163 patientsSponsorUnicancer

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