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

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What is this study about?

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.

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 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 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 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 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 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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Hospital Universitario Y Politecnico La Fe Valencia Spain
Hospital Clinico San Carlos Madrid Spain

Other Sites

Site Name City Country Status
Hospital General Universitario Gregorio Maranon Madrid Spain
Hospital Universitario Fundacion Jimenez Diaz Madrid Spain
Hospital Universitario De Canarias La Laguna Spain
Hinuyasu Da Lm Smjzr Cuwi I Sfuu Pda Barcelona Spain
Fvbwzrqxf Pqfd Lv Ihgcyphrgakqw Blbphzctu Dew Heiuutlv Uoezvpcsmrmzm Le Pno Madrid Spain
Hwxgxjay Vojn dkmkebtq Barcelona Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Spain Spain
Recruiting
25.05.2021

Trial locations

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.

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 ID:
2023-509215-81-00
Protocol code:
Geis-75
NCT ID:
NCT05131386
Trial Phase:
Therapeutic exploratory (Phase II)

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