Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Recruiting

Study on Ifosfamide and Doxorubicin for Patients with High-Grade Soft Tissue Sarcoma in the Limbs and Trunk Wall

Verified siteRegistered drug
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

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 called high-grade soft tissue sarcoma, which affects the muscles, fat, and other soft tissues in the arms, legs, and trunk. The study is testing two medications, ifosfamide and doxorubicin, which are given as a solution through a vein. These medications are used in a sequence to see how well they work in shrinking the tumors before surgery.

The purpose of the study is to evaluate how many patients show a reduction in tumor size when treated with these medications. Participants will receive the treatment over a period of time, and their response to the treatment will be monitored using imaging techniques. The study will also look at the safety of the treatment and how it affects the quality of life of the participants.

Throughout the study, researchers will collect information to understand how the treatment works and identify any markers that might predict how well a patient responds to the therapy. This information could help improve treatment strategies for patients with soft tissue sarcoma in the future.

The research process

The trial runs in 7 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, eligibility is confirmed based on specific criteria such as age, organ function, and medical history.

    A histological diagnosis of soft tissue sarcoma is required, and the tumor must be measurable according to specific guidelines.

  2. Step 2

    Initial assessment

    An initial assessment is conducted to evaluate the patient's health status and to collect baseline data.

    This includes laboratory tests to ensure adequate organ function and bone marrow reserve.

  3. Step 3

    Treatment phase 1

    The first phase of treatment involves the administration of doxorubicin hydrochloride and ifosfamide.

    These medications are given as a solution for injection through intravenous use.

    The specific dosage and frequency are determined by the medical team based on individual patient needs.

  4. Step 4

    Monitoring and evaluation

    Throughout the treatment, regular monitoring is conducted to assess the response to the medication.

    This includes imaging studies to evaluate the size of the tumor and laboratory tests to monitor organ function.

  5. Step 5

    Treatment phase 2

    The second phase of treatment continues with the administration of the same medications, doxorubicin hydrochloride and ifosfamide.

    Adjustments to the treatment plan may be made based on the patient's response and any side effects experienced.

  6. Step 6

    Final assessment

    A final assessment is conducted to determine the overall response to the treatment.

    This includes evaluating the tumor size and any changes in the patient's health status.

  7. Step 7

    Follow-up

    After the treatment phase, follow-up appointments are scheduled to monitor the patient's health and any long-term effects of the treatment.

    These appointments may include additional imaging studies and laboratory tests.

Who can join the trial?

20 criteria

  • Must be **18 years or older** at the time of giving consent to participate.
  • Must have **adequate organ function** and **bone marrow reserve**. This means certain blood tests should show:
    • Hemoglobin (a protein in red blood cells) should be **8.0 g/dL or higher**.
    • Neutrophil count (a type of white blood cell) should be **1.0 x 109/L or higher**.
    • Platelet count (cells that help with blood clotting) should be **75 x 109/L or higher**.
    • Total bilirubin (a substance made by the liver) should be **1.5 times the normal limit or lower**.
    • Creatinine clearance (a measure of kidney function) should be **60 ml/min or higher**.
    • Must test **negative for Hepatitis B and C and HIV**.
    • Women who can have children and their partners must use **effective birth control** during the study and for one year after the last dose of study medication. Women must have a **negative pregnancy test** before starting the study.
    • Must have a **histological diagnosis** (a diagnosis made by examining tissue under a microscope) of a specific type of **soft tissue sarcoma**. These types include:
      • Leiomyosarcoma
      • Malignant peripheral nerve sheath tumor
      • Undifferentiated pleomorphic sarcoma
      • Myxofibrosarcoma
      • Synovial sarcoma
      • Pleomorphic liposarcoma
      • Pleomorphic rhabdomyosarcoma
      • Unclassified spindle cell sarcoma
      • The **tumor must be located** in the arms, legs, or trunk (the main part of the body).
      • The **primary tumor** must be available for a **biopsy** (a small sample of tissue taken for testing).
      • Must have a **measurable tumor** according to specific guidelines (RECIST v1.1).
      • Must have an **ECOG performance status** of 0 or 1, which means the patient is fully active or has some symptoms but can carry out light work.

Who cannot join the trial?

7 criteria

  • Patients who do not have a high-grade soft tissue sarcoma in the arms, legs, or trunk wall. A sarcoma is a type of cancer that starts in the body's soft tissues, like muscles or fat.
  • Patients who are not within the specified age range for the study. The study is open to certain age groups only.
  • Patients who are not willing or able to follow the study procedures and requirements.
  • Patients who have other medical conditions that might interfere with the study or make it unsafe for them to participate.
  • Patients who are pregnant or breastfeeding, as the study may involve treatments that could affect the baby.
  • Patients who are participating in another clinical trial at the same time, as this could affect the results of the study.
  • Patients who have had certain treatments or medications recently that might interfere with the study.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

  • Ifosfamide

    is a chemotherapy medication used to treat certain types of cancer. In this trial, it is used as part of a treatment plan for patients with high-grade soft tissue sarcoma. It works by interfering with the growth and spread of cancer cells in the body.

  • Doxorubicin

    is another chemotherapy drug used in this trial. It is used to treat various types of cancer, including soft tissue sarcoma. Doxorubicin works by slowing or stopping the growth of cancer cells. In this study, it is used in combination with ifosfamide to enhance the treatment's effectiveness against the cancer.

What is already known about the treatment

  • Ifosfamide

    Ifosfamide is administered intravenously and is used in the treatment of high-grade soft tissue sarcoma, particularly in the extremities and trunk wall. It is currently recognized in medical literature as a chemotherapy agent. The main therapeutic indication is for use in neoadjuvant chemotherapy to shrink tumors before surgery. At the molecular level, ifosfamide works by interfering with the DNA replication process in cancer cells, leading to cell death. It is classified as an alkylating agent in pharmacology.

  • Doxorubicin

    Doxorubicin is given intravenously and is used to treat high-grade soft tissue sarcoma, especially in the extremities and trunk wall. It is well-documented in medical literature as a chemotherapy drug. The primary therapeutic use is in neoadjuvant chemotherapy to reduce tumor size before surgical intervention. Doxorubicin acts by intercalating DNA strands, disrupting the replication and transcription processes, which results in cancer cell death. It belongs to the anthracycline class of drugs.

Investigated diseases

High-Grade Soft Tissue Sarcoma – This is a type of cancer that originates in the soft tissues of the body, such as muscles, fat, nerves, and blood vessels. It is characterized by the presence of abnormal cells that grow uncontrollably and can invade nearby tissues. High-grade sarcomas are aggressive and tend to grow and spread more quickly than low-grade sarcomas. They are most commonly found in the extremities and trunk wall. As the disease progresses, it can lead to the formation of a noticeable lump or swelling, and may cause pain or functional impairment depending on its location. The progression of the disease can vary, with some tumors growing rapidly while others may remain stable for a period of time.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-510185-27-00Estimated enrolment50 patientsSponsorOslo University Hospital HF

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

ClinicalTrials.eu

Every clinical trial in Europe, in plain language.

Explore the full ecosystem of clinical research in Europe.

Search trials

Legal notice · Published by CTIN POLAND sp. z o.o., ul. rtm. Witolda Pileckiego 67/109, 02-781 Warsaw, Poland · KRS 0001111334 · REGON 528919042 · NIP 9512598637

© 2026 Clinical Trials EU – European Clinical Trials Information Network

GDPR compliance, ISO 9001 and ISO 27001 certified (LL-C Certification)

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).