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Study on Trabectedin and Radiotherapy for Patients with Soft Tissue 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 is focused on studying a type of cancer known as soft tissue sarcoma. The treatment being tested combines a medication called Trabectedin with radiotherapy. Trabectedin is a drug that is administered through an intravenous infusion, which means it is given directly into the bloodstream through a vein. The purpose of the study is to find the best dose of Trabectedin that can be safely used with radiotherapy to treat patients with soft tissue sarcoma.

Participants in the study will receive the combination of Trabectedin and radiotherapy. The study will monitor how well the treatment works and any side effects that may occur. The goal is to determine the most effective and safe dose of Trabectedin when used with radiotherapy. The study will also look at how the treatment affects the cancer's response and the chances of the cancer returning over a period of five years.

The study is divided into different groups, each receiving specific doses of Trabectedin to find the most suitable one. The researchers will collect information on how the cancer responds to the treatment and any side effects experienced by the participants. This information will help in understanding the best way to use Trabectedin with radiotherapy for treating soft tissue sarcoma.

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

    The patient must sign an informed consent form before any study-specific tests are conducted.

    Eligibility is confirmed based on specific criteria, including age, tumor type, and health status.

  2. Step 2

    Treatment preparation

    A central venous catheter is required for administering the treatment.

    The patient undergoes necessary tests to ensure they meet the health requirements for participation.

  3. Step 3

    Treatment administration

    The patient receives trabectedin, a medication administered through intravenous infusion.

    The dosage and frequency are determined based on the patient's cohort and the study's phase.

  4. Step 4

    Combination with radiotherapy

    Trabectedin is combined with radiation therapy to treat soft tissue sarcoma.

    The combination aims to determine the maximum tolerated dose and assess the treatment's effectiveness.

  5. Step 5

    Monitoring and evaluation

    The patient's response to the treatment is monitored using specific criteria such as RECIST and CHOI.

    Adverse effects are recorded to adjust the dosage if necessary.

  6. Step 6

    Follow-up

    The patient is monitored for long-term outcomes, including relapse-free survival rates.

    Regular follow-up appointments are scheduled to assess the patient's health and treatment efficacy.

Who can join the trial?

13 criteria

  • The patient must voluntarily sign the informed consent form before any study-specific tests that are not part of their usual care.
  • The patient must be aged between 18 and 75 years.
  • For Cohort C, the patient must have certain types of tumors: high-grade leiomyosarcoma, liposarcoma with at least 30% dedifferentiation, or pleomorphic liposarcoma. For Cohort D, the patient must have well-differentiated liposarcoma or G2 dedifferentiated liposarcoma with less than 30% dedifferentiation. A centralized diagnosis will confirm eligibility.
  • The tumor must be located in the retroperitoneum (the area behind the abdominal organs) and must be removable without signs of spreading. This must be confirmed by a central surgeon reviewer.
  • The location and size of the disease must allow for safe radiation treatment, confirmed by radiation oncologists.
  • The disease must be measurable according to specific criteria: CHOI criteria for Cohort C and RECIST V 1.1 criteria for Cohort D.
  • The patient must have an ECOG performance status of 0-1, which means they are fully active or have some restrictions but can still carry out light work.
  • The patient must have adequate blood parameters, including specific levels of hemoglobin, white blood cells, neutrophils, and platelets. Certain liver and kidney function tests must also be within acceptable limits.
  • Fertile men and women must use effective birth control before, during, and for 6 months after the study. Women of childbearing potential must take a pregnancy test before starting the study.
  • The patient must have normal heart function, with a left ventricular ejection fraction (LVEF) of 50% or higher, as shown by an echocardiogram or MUGA scan.
  • Tests for hepatitis B (HBV) and hepatitis C (HCV) must be done before the study. If certain tests are positive, the patient may not be recommended for the study, and preventive treatment may be considered.
  • The patient may have had one previous chemotherapy treatment, but this applies only to Cohort D.
  • The patient must have a central venous catheter, which is a tube placed in a large vein, for administering the treatment.

Who cannot join the trial?

4 criteria

  • Patients who do not have soft tissue sarcoma. This is a type of cancer that starts in the soft tissues of the body, like muscles, fat, or blood vessels.
  • Patients who are not within the specified age range for the study.
  • Patients who are part of a vulnerable population, which means they might need special protection or care.
  • Patients who are not eligible based on other specific criteria set by the study, which are not detailed here.
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Investigated drugs

  • Trabectedin

    is a medication used in this trial to treat patients with soft tissue sarcoma. It is being studied in combination with radiation therapy to determine the best dose that can be safely given to patients. The trial aims to find out how well this combination works in shrinking tumors and improving survival rates in different groups of patients. Trabectedin is known for its ability to interfere with the growth of cancer cells, and researchers are looking to see how it can be effectively used alongside radiation therapy.

  • Radiation Therapy

    is a treatment that uses high-energy rays to target and kill cancer cells. In this trial, it is combined with trabectedin to see if the two treatments together can be more effective than radiation therapy alone. The goal is to enhance the treatment's ability to reduce tumor size and improve the chances of long-term survival for patients with soft tissue sarcoma.

What is already known about the treatment

Trabectedin – Trabectedin is administered intravenously and is currently being studied in clinical trials for its use in treating soft tissue sarcoma. It is an approved medication in some regions for specific cancer types, and ongoing research is exploring its combination with radiation therapy. The main therapeutic indication for trabectedin is soft tissue sarcoma, where it works by binding to the DNA minor groove, disrupting the cell cycle, and ultimately leading to cancer cell death. It is classified as an antineoplastic agent, specifically a DNA-binding agent, and is being evaluated to determine the optimal dose and safety profile when used alongside radiation therapy.

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 can occur in any part of the body but is most commonly found in the arms, legs, and trunk. It often starts as a painless lump or swelling and may grow slowly or rapidly. As it progresses, it can cause pain or interfere with the function of nearby organs and tissues. The exact cause of soft tissue sarcoma is not well understood, but it may involve genetic mutations or exposure to certain chemicals or radiation.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase ITrial ID2024-518199-30-00Estimated enrolment163 patientsSponsorAsoc Grupo Espanol De Investigacion En Sarcomas

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