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Study on the Effectiveness of Doxorubicin, Ifosfamide, and Dacarbazine in High-Risk Patients with Resectable Soft-Tissue Sarcoma

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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 a type of cancer known as soft-tissue sarcoma, which is a cancer that develops in the soft tissues of the body, such as muscles, fat, and blood vessels. The study is specifically looking at cases where the cancer can be surgically removed and has not spread to other parts of the body. The purpose of the study is to see if adding more chemotherapy before surgery can improve outcomes for patients who are at high risk. Chemotherapy is a treatment that uses drugs to kill cancer cells, and in this study, the drugs being used are doxorubicin, dacarbazine, and ifosfamide. These drugs are given through a process called infusion, where the medication is delivered directly into the bloodstream through a vein.

The study will involve several steps. Initially, patients will receive three cycles of chemotherapy with doxorubicin, followed by surgery to remove the tumor. Some patients will receive additional cycles of chemotherapy before surgery to see if this improves their chances of staying cancer-free. After surgery, patients may also receive radiotherapy, which uses high-energy rays to target and kill any remaining cancer cells. The main goal is to see if this approach helps patients live longer without the cancer coming back or spreading.

Throughout the study, doctors will monitor patients closely to see how well the treatment is working and to check for any side effects. The study will last for several years to gather enough information to determine if the intensified chemotherapy approach is beneficial. The results will help doctors understand if this treatment plan can be used to improve the care of patients with high-risk soft-tissue sarcoma in the future.

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

    Initial assessment

    Upon joining the trial, an initial assessment is conducted to confirm eligibility. This includes a review of medical history and a physical examination.

    A negative pregnancy test is required for women of childbearing potential. Both men and women must agree to use contraception during the trial and for one year after treatment ends.

  2. Step 2

    Neoadjuvant chemotherapy - phase 1

    The first phase of treatment involves three cycles of chemotherapy before surgery. This is known as neoadjuvant chemotherapy.

    The medications used are doxorubicin hydrochloride, dacarbazine, and ifosfamide. These are administered through an intravenous infusion, which means they are given directly into a vein.

    Each cycle lasts for a specific period, followed by a rest period to allow the body to recover.

  3. Step 3

    Surgery

    After completing the initial chemotherapy cycles, surgery is performed to remove the soft-tissue sarcoma.

    The timing of the surgery is determined based on the response to chemotherapy and the overall health status.

  4. Step 4

    Neoadjuvant chemotherapy - phase 2

    Following surgery, an additional three cycles of chemotherapy are administered. This is an intensified treatment phase aimed at reducing the risk of cancer returning.

    The same medications are used: doxorubicin hydrochloride, dacarbazine, and ifosfamide, given through intravenous infusion.

  5. Step 5

    Radiotherapy (if applicable)

    Radiotherapy may be recommended based on the surgical outcomes and the characteristics of the sarcoma.

    This treatment uses high-energy rays to target and destroy any remaining cancer cells.

  6. Step 6

    Follow-up and monitoring

    Regular follow-up appointments are scheduled to monitor health status and detect any signs of cancer recurrence.

    These appointments include physical exams, imaging tests, and laboratory tests as needed.

Who can join the trial?

12 criteria

  • The patient must have a type of cancer called soft-tissue sarcoma, which can be removed by surgery and has not spread to other parts of the body.
  • The cancer must be confirmed by a special network of experts in France.
  • Women who can have children must have a negative pregnancy test before joining the study. Both men and women must agree to use a reliable method of birth control during the study and for one year after stopping treatment.
  • The patient must sign a written consent form to participate in the study.
  • The patient must have social security that complies with French law.
  • The cancer must be classified as Grade 2 or 3 according to a specific grading system, which indicates the aggressiveness of the cancer.
  • A sample of the tumor must be available for research purposes.
  • The patient must not have received any previous treatment for this cancer.
  • The patient must be at least 18 years old.
  • The patient must have a life expectancy of at least 3 months.
  • The patient must have a performance status of 0 or 1 on the ECOG scale, which measures how well they can perform daily activities.
  • The patient must have a measurable disease, meaning the cancer can be measured in size using specific criteria.

Who cannot join the trial?

7 criteria

  • Patients with **metastatic** soft-tissue sarcoma cannot participate. This means the cancer has spread to other parts of the body.
  • Patients who are not considered **high-risk CINSARC** are excluded. CINSARC is a specific way to assess the risk level of the cancer.
  • Patients who cannot undergo **surgery** are not eligible. Surgery is a procedure to remove the cancer.
  • Patients who cannot receive **chemotherapy** are excluded. Chemotherapy is a treatment using drugs to kill cancer cells.
  • Patients who cannot receive **radiotherapy** are not eligible. Radiotherapy uses high-energy rays to destroy cancer cells.
  • Patients under the age of 18 or over the age of 65 are excluded. The study is for adults between these ages.
  • Patients who are part of a **vulnerable population** are not eligible. This refers to groups who may need special protection or care.
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Investigated drugs

Doxorubicin is a chemotherapy medication used in this trial. It is part of the treatment plan for patients with high-risk soft-tissue sarcomas. The trial is investigating whether adding more cycles of doxorubicin before surgery can improve patient outcomes. Doxorubicin works by slowing or stopping the growth of cancer cells.

What is already known about the treatment

Doxorubicin – Doxorubicin is administered intravenously and is commonly used in chemotherapy treatments. It is currently well-established in medical practice and literature as a treatment for various types of cancer, including soft-tissue sarcoma. The main therapeutic indication for doxorubicin in this trial is to improve outcomes in patients with high-risk, resectable soft-tissue sarcoma. At the molecular level, doxorubicin works by intercalating DNA, which disrupts the replication of cancer cells and ultimately leads to cell death. It is classified as an anthracycline antibiotic in pharmacology.

Investigated diseases

Soft-Tissue Sarcoma – Soft-tissue sarcoma is a type of cancer that begins in the tissues that connect, support, or surround other structures and organs of the body. These tissues include muscle, fat, blood vessels, nerves, tendons, and the lining of the joints. The disease is characterized by the growth of abnormal cells that form a mass or tumor. It is considered resectable when the tumor can be surgically removed and non-metastatic when it has not spread to other parts of the body. The progression of soft-tissue sarcoma can vary, with some tumors growing slowly and others more rapidly. The risk of recurrence or spread depends on various factors, including the size and location of the tumor.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-509489-39-00Protocol codeIB2017-04Estimated enrolment351 patientsSponsorInstitut Bergonie

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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).