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Study on the Effect of Chemotherapy with Ifosfamide, Dacarbazine, and Epirubicin Hydrochloride Before Surgery for Patients with High-Risk Retroperitoneal Sarcoma

Fast replyRegistered 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 chemotherapy before surgery in patients with a type of cancer called retroperitoneal sarcoma. This cancer occurs in the area behind the abdominal organs. The study specifically looks at two subtypes of this cancer: leiomyosarcoma and liposarcoma. The treatment being tested involves using chemotherapy drugs such as ifosfamide, dacarbazine, epirubicin hydrochloride, and doxorubicin hydrochloride. These drugs are given through a vein, which is known as intravenous use.

The purpose of the study is to see if giving chemotherapy before surgery can improve the chances of the cancer not coming back after surgery. Patients will be randomly assigned to receive either chemotherapy followed by surgery or surgery alone. The study will last for several years, and patients will be monitored for their health and any signs of cancer returning. The main focus is on how long patients remain free of cancer after treatment, which is called disease-free survival. Other aspects being studied include overall survival, the response of the cancer to the chemotherapy, and any side effects from the treatment.

Participants in the study will undergo various tests and procedures, including imaging tests like MRI and CT scans, to assess the size and spread of the cancer. These tests help doctors determine if the cancer can be surgically removed. The study aims to gather information that could help improve treatment strategies for patients with high-risk retroperitoneal sarcoma, potentially leading to better outcomes and quality of life.

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

    Joining the study

    Upon joining the study, the patient will be randomly assigned to one of two groups: one group will receive chemotherapy before surgery, and the other group will undergo surgery alone.

    The purpose of this study is to determine if receiving chemotherapy before surgery improves outcomes for patients with high-risk retroperitoneal sarcoma.

  2. Step 2

    Chemotherapy treatment

    If assigned to the chemotherapy group, the patient will receive a combination of medications through an intravenous (IV) line. These medications include ifosfamide, dacarbazine, epirubicin hydrochloride, and doxorubicin hydrochloride.

    The specific dosage, frequency, and duration of administration will be determined by the medical team based on individual patient needs and the study protocol.

  3. Step 3

    Surgery

    After completing the chemotherapy treatment, or if assigned to the surgery-only group, the patient will undergo surgery to remove the tumor.

    The surgery aims to achieve complete removal of the tumor with the intent to cure.

  4. Step 4

    Post-surgery follow-up

    Following surgery, the patient will have regular follow-up appointments to monitor recovery and check for any signs of cancer recurrence.

    These follow-up visits will include physical examinations and imaging tests as needed.

  5. Step 5

    Ongoing monitoring

    The patient will continue to be monitored for overall survival, recurrence-free survival, and any potential side effects or complications from the treatment.

    The study will also assess the patient's quality of life and any changes in health status over time.

Who can join the trial?

15 criteria

  • Must have a confirmed diagnosis of primary high-risk leiomyosarcoma (LMS) or liposarcoma (LPS) in specific areas of the body (retroperitoneal space or infra-peritoneal spaces of the pelvis).
  • Tumor tissue must be collected for a central pathology review. If not enough tissue is available, this may be acceptable, but if no tissue is available, the patient cannot participate.
  • Must be at least 18 years old with no upper age limit.
  • Must have a WHO performance status of 2 or less. This is a measure of the patient's ability to perform daily activities.
  • Must have adequate blood and organ function.
  • Must have an American Society of Anesthesiologists (ASA) score of less than 3. This score assesses the physical health of patients before surgery.
  • Tumor tissue and blood samples must be collected for research purposes. If blood samples are not collected, the patient cannot participate.
  • Women who can become pregnant must have a negative pregnancy test before starting the study.
  • Women who can become pregnant must use highly effective birth control during the study and for at least 6 months after the last treatment. If receiving a specific chemotherapy (ifosfamide), birth control should continue for 1 year after treatment.
  • Men in the study must agree to use birth control or remain abstinent and not donate sperm.
  • Women who are breastfeeding must stop nursing before starting the study and until 6 months after the last treatment.
  • Must provide written informed consent to participate in the study.
  • Must have a unifocal tumor, meaning the tumor is located in one area.
  • The tumor must be resectable, meaning it can be surgically removed, as determined by imaging tests.
  • Must have a tumor that can be measured by imaging tests, such as a CT scan or MRI.

Who cannot join the trial?

7 criteria

  • Patients with any other type of cancer besides leiomyosarcoma or liposarcoma in the specified areas cannot participate. Leiomyosarcoma is a type of cancer that affects smooth muscle tissue, and liposarcoma is a cancer that arises in fat cells.
  • Patients who have had previous treatments that might interfere with the study results are not eligible.
  • Individuals with severe or uncontrolled medical conditions that could affect their safety or the study outcomes cannot join.
  • Pregnant or breastfeeding women are excluded from participating in the study.
  • Patients who are unable to follow the study procedures or attend required visits are not eligible.
  • Individuals with known allergies to the study medication or its components cannot participate.
  • Patients who are currently participating in another clinical trial are not eligible.
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Investigated drugs

Neoadjuvant Chemotherapy is a treatment given before the main treatment, which in this case is surgery. The goal of this chemotherapy is to shrink the tumor in patients with high-risk retroperitoneal sarcoma, making it easier to remove during surgery. This approach aims to improve the chances of successful surgery and increase the time patients remain free of the disease after treatment.

What is already known about the treatment

Neoadjuvant Chemotherapy – This medication is administered intravenously, meaning it is given through a vein, usually in the arm. It is currently being studied in clinical trials to determine its effectiveness in treating high-risk retroperitoneal sarcoma, a type of cancer that occurs in the abdominal area. The main therapeutic use of this chemotherapy is to shrink tumors before surgery, potentially improving the outcome for patients with specific types of sarcoma, such as leiomyosarcoma and liposarcoma. At the molecular level, chemotherapy works by targeting and killing rapidly dividing cancer cells, disrupting their growth and reproduction. It is classified as an antineoplastic agent, which is a type of drug used to treat cancer.

Investigated diseases

  • Leiomyosarcoma

    Leiomyosarcoma is a type of soft tissue sarcoma that originates from smooth muscle cells. It can develop in any part of the body but is most commonly found in the uterus, stomach, or intestines. The disease progresses as the cancerous cells grow and form a mass, which can invade nearby tissues. Over time, it may spread to other parts of the body through the bloodstream or lymphatic system. The growth rate and pattern of spread can vary, with some tumors growing slowly and others more rapidly. As the disease advances, it can cause symptoms related to the affected organs or tissues.

  • Liposarcoma

    Liposarcoma is a malignant tumor that arises from fat cells in deep soft tissue, such as that inside the thigh or in the retroperitoneum. It is one of the most common types of soft tissue sarcoma in adults. The disease progresses as the tumor enlarges and can invade surrounding tissues. It may also metastasize to distant organs, although this is less common. The growth of liposarcoma can vary, with some tumors being aggressive and others more indolent. Symptoms often depend on the tumor's location and size, potentially causing pain or functional impairment.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-505261-84-00Protocol codeEORTC-1809-STBSGEstimated enrolment253 patientsSponsorEuropean Organisation For Research And Treatment Of Cancer

sourced from the EU Clinical Trials Register and site verification

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