Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Recruiting

Study of Trabectedin and Low-Dose Radiation Therapy for Adults and Young Adults with Advanced or Metastatic Soft Tissue and Bone Sarcomas

Verified siteRegistered drugNo placebo
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 focuses on patients with advanced/metastatic sarcomas, which are cancers that develop in soft tissues, bones, or appear as small round-cell tumors. The study specifically looks at three types: soft tissue sarcoma, bone tumors (including osteosarcoma and chondrosarcoma), and small round-cell sarcomas (including Ewing's sarcoma, rhabdomyosarcoma, and other related tumors).

The study combines two types of treatment: a medication called trabectedin (given through an intravenous infusion) and low-dose radiation therapy. Trabectedin is administered as a solution that is prepared from a powder and given through a special tube placed in a vein. The dose used in this study is 1.5 milligrams per square meter of body surface.

The main goal of this research is to determine how well tumors respond to this combination treatment, particularly in areas that receive radiation therapy. Throughout the study, researchers will monitor changes in tumor size, track how long the treatment remains effective, and assess its effects on pain levels and overall well-being. They will also carefully watch for any side effects that may occur during treatment.

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

    Enrollment

    Upon joining the study, a central diagnosis confirmation is required. A tumor sample must be available and sent during the screening process.

    A central venous catheter is necessary for the administration of the medication.

  2. Step 2

    Treatment initiation

    The treatment involves the administration of trabectedin, which is provided as a solution for infusion.

    The medication is administered through an intravenous infusion.

  3. Step 3

    Radiation therapy

    Low-dose radiation therapy is applied to specific lesions. The dose for extremities is 45 Gy, while for non-extremity areas, it is 30 Gy.

    The radiation oncologist confirms that the disease distribution allows for meeting normal tissue constraints.

  4. Step 4

    Treatment cycles

    The treatment is administered in cycles. Variations in pain and quality of life are assessed on day 1 of every cycle until cycle 10, and then on day 1 every other cycle.

    Safety and toxicity are monitored through physical examinations and laboratory tests, graded using standard criteria.

  5. Step 5

    Evaluation of response

    The overall response rate in the irradiated nodules is evaluated according to specific criteria.

    Progression-free survival and overall survival are measured to assess the efficacy of the treatment.

  6. Step 6

    Completion

    The trial is estimated to end by May 27, 2025.

    The patient's participation continues until the completion of the treatment cycles or until the study's end date.

Who can join the trial?

17 criteria

  • Patients must provide written informed consent before any study-specific procedures and agree to follow the treatment and check-ups.
  • Patients should have a **performance status** of 1 or less. This means they should be able to carry out light activities.
  • Patients must have good **respiratory function** if they have lung-related tumors. This includes a **FEV1** (a lung function test) greater than 1 liter and **DLCO** (another lung test) greater than 40%.
  • Patients need to have healthy **bone marrow function**, which means having enough red blood cells, white blood cells, and platelets. Specific numbers are required for each.
  • Patients must have normal levels of certain substances in their blood, like creatinine, albumin, and liver enzymes.
  • Men and women who can have children must use effective birth control during the study and for 6 months after the last dose of the study drug. Women must have a negative pregnancy test before starting the study.
  • Patients must have normal **heart function**, with a **LVEF** (a heart test) of 50% or more.
  • Patients must be tested for **hepatitis B** and **hepatitis C** before joining the study. If certain tests are positive, they may not be able to participate.
  • Patients need to have a **central venous catheter**, which is a special tube used to give the study drug.
  • Patients must be between 16 and 75 years old.
  • Patients must have a diagnosis of certain types of **sarcoma** (a type of cancer) that is advanced or has spread and cannot be removed by surgery.
  • The cancer must be in a location that allows safe radiation treatment, confirmed by a radiation doctor.
  • The tumors chosen for radiation must be causing significant symptoms.
  • Patients must show that their disease has gotten worse in the last 6 months before joining the study.
  • Patients must be eligible for chemotherapy and have had at least one previous treatment, but no more than three, for advanced cancer. The study drug must not have been used before.
  • The following types of sarcoma are eligible: soft tissue sarcoma, bone tumors (like osteosarcoma and chondrosarcoma), and small round-cell sarcomas (like Ewing's sarcoma and rhabdomyosarcoma).
  • Patients must have **measurable disease**, meaning the cancer can be measured using specific criteria.

Who cannot join the trial?

4 criteria

  • Patients who have not been diagnosed with advanced or metastatic soft tissue sarcoma, bone tumors like osteosarcoma or chondrosarcoma, or small round-cell sarcomas such as Ewing's sarcoma, rhabdomyosarcoma, desmoplastic small round-cell tumors, or other small round cell sarcomas.
  • Patients without measurable disease, which means the tumors cannot be measured accurately using medical imaging.
  • Patients who are not adults or young adults, as the study is focused on these age groups.
  • Patients who are part of a vulnerable population, which means they might need special protection or care.
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

  • Trabectedin

    is a medication used in this trial to treat advanced or metastatic sarcomas. It works by interfering with the growth of cancer cells, slowing their spread in the body. Trabectedin is often used when other treatments have not been effective.

  • Low-dose radiation therapy

    is a treatment that uses high-energy rays to target and destroy cancer cells. In this trial, it is combined with trabectedin to enhance the treatment's effectiveness against sarcomas. The radiation is carefully controlled to minimize damage to healthy tissues surrounding the cancer.

What is already known about the treatment

Trabectedin – Trabectedin is administered intravenously, typically as an infusion. It is currently being studied in clinical trials for its effectiveness in treating advanced or metastatic soft tissue sarcomas and bone tumors, including osteosarcoma and chondrosarcoma. The main therapeutic indication is for patients with measurable disease in these types of cancers. Trabectedin works by binding to the minor groove of DNA, disrupting the cell cycle and leading to cell death, particularly in cancer cells. It is classified as an antineoplastic agent, specifically a DNA-binding agent.

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. It can occur in various locations, including muscles, fat, blood vessels, nerves, tendons, and the lining of the joints. The disease often starts as a painless lump, but as it grows, it may cause pain or interfere with bodily functions. Over time, it can spread to other parts of the body, making it more challenging to manage. The progression of the disease varies depending on the type and location of the sarcoma.

  • Osteosarcoma

    Osteosarcoma is a type of bone cancer that typically starts in the long bones, such as those in the arms and legs. It is most common in teenagers and young adults, often during periods of rapid growth. The disease usually presents as pain and swelling in the affected area, which may worsen over time. As the tumor grows, it can weaken the bone, leading to fractures. Osteosarcoma can spread to other parts of the body, particularly the lungs, if not addressed.

  • Chondrosarcoma

    Chondrosarcoma is a cancer that forms in cartilage cells, often affecting the pelvis, hip, and shoulder regions. It is more common in adults and can vary in aggressiveness. The disease may cause pain, swelling, or a noticeable mass in the affected area. As it progresses, it can invade nearby tissues and spread to other parts of the body. The growth rate and behavior of chondrosarcoma depend on its specific type and location.

  • Ewing's Sarcoma

    Ewing's sarcoma is a rare cancer that occurs in bones or the soft tissue around the bones, primarily affecting children and young adults. It often begins in the legs, pelvis, or chest wall and can cause pain, swelling, or a palpable mass. The disease can spread quickly to other parts of the body, including the lungs and other bones. Early detection and management are crucial to controlling its progression.

  • Rhabdomyosarcoma

    Rhabdomyosarcoma is a cancer that develops from skeletal muscle cells, commonly affecting children. It can occur in various parts of the body, including the head, neck, bladder, and limbs. Symptoms depend on the tumor's location and may include a visible lump, pain, or difficulty with normal functions. The disease can spread to other areas, such as the lungs and lymph nodes, if not managed promptly.

  • Desmoplastic Small Round Cell Tumor

    Desmoplastic small round cell tumor is a rare and aggressive cancer that typically occurs in the abdomen. It primarily affects young males and is characterized by small, round cancer cells surrounded by dense fibrous tissue. Symptoms may include abdominal pain, swelling, or a palpable mass. The disease can spread to other organs and tissues, making it challenging to manage. Its progression is often rapid, requiring comprehensive care.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-509215-81-00Protocol codeGeis-75Estimated enrolment98 patientsSponsorAsoc Grupo Espanol De Investigacion En Sarcomas

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.