Clinical trial locations
- Cyprus
- Czechia
- Denmark
- France
- Germany
- Italy
- Netherlands
- Poland
- Slovakia
- Spain
Study on the Effect of Chemotherapy with Ifosfamide, Dacarbazine, and Epirubicin Hydrochloride Before Surgery for Patients with High-Risk Retroperitoneal Sarcoma
This trial investigates whether giving chemotherapy before surgery improves outcomes for patients with high-risk retroperitoneal sarcoma, including leiomyosarcoma. The study compares two approaches: chemotherapy followed by surgery versus surgery alone.
Who can participate: Patients must be at least 18 years old with confirmed primary high-risk leiomyosarcoma or liposarcoma in the retroperitoneal space or infra-peritoneal spaces of the pelvis. The tumor must be surgically removable as determined by imaging tests and must be unifocal (located in one area). Adequate blood and organ function, WHO performance status of 2 or less, and ASA score less than 3 are required. Tumor tissue and blood samples must be collected for research. Women who can become pregnant must use highly effective birth control during the study and for at least 6 months after treatment.
Who cannot participate: Patients with cancer types other than leiomyosarcoma or liposarcoma in specified areas, those who have had previous treatments that might interfere with results, individuals with severe or uncontrolled medical conditions, pregnant or breastfeeding women, patients unable to follow study procedures, those with known allergies to study medications, and individuals currently participating in another clinical trial are excluded.
Study goals: The primary focus is determining whether chemotherapy given before surgery (neoadjuvant chemotherapy) improves disease-free survival compared to surgery alone. Researchers will assess how long patients remain free of cancer after treatment, overall survival rates, tumor response to chemotherapy, and any treatment-related side effects. Regular imaging tests will monitor tumor size and spread throughout the study.
Investigational drugs: Neoadjuvant chemotherapy using a combination of ifosfamide, dacarbazine, epirubicin hydrochloride, and doxorubicin hydrochloride is given intravenously before surgery. The goal is to shrink tumors, making them easier to remove and potentially improving surgical outcomes and long-term disease control.
Study on the Effectiveness and Safety of INT230-6 (Vinblastine Sulfate, Cisplatin) for Adults with Metastatic Soft Tissue Sarcomas
This trial tests a new treatment called INT230-6, which is injected directly into tumors, for patients with certain types of soft tissue sarcomas including leiomyosarcoma. The study compares INT230-6 with standard care treatments currently used in the United States.
Who can participate: Patients must be at least 18 years old with confirmed soft tissue sarcoma (liposarcoma, leiomyosarcoma, or undifferentiated pleomorphic sarcoma) that cannot be removed by surgery, is locally advanced, or has spread to other parts of the body. Participants must have received at least one previous treatment for advanced disease and shown disease progression after anthracycline-based therapy, but not more than two previous treatments. At least one tumor must be suitable for injection (at least 2 cm in size and measurable by CT or MRI). ECOG performance status of 0, 1, or 2 is required, along with adequate organ function. Female participants must use effective contraception during the study and for 7 months after, while male participants must use contraception for 6 months after the study ends.
Who cannot participate: Patients with unspecified cancer types, recent major surgery, severe heart problems, uncontrolled infections, pregnancy or breastfeeding status, inability to follow study procedures, recent participation in another clinical trial, history of allergic reactions to study medication, severe liver or kidney disease, or history of drug or alcohol abuse are excluded.
Study goals: The primary aim is comparing overall survival of patients receiving INT230-6 with those receiving standard care treatments (which may include Halaven, Trabectedin, or Pazopanib). Researchers will monitor participants' health and response to treatment over up to 24 months, assessing effectiveness, side effects, and overall quality of life.
Investigational drugs: INT230-6 is a combination therapy injected directly into tumors, containing SHAO (a proprietary formulation), vinblastine, and cisplatin. This approach aims to destroy cancer cells by disrupting their DNA and inhibiting cell division, with the goal of improving survival for patients with soft tissue sarcomas that cannot be surgically removed or have spread to other body parts.
Summary
The four ongoing clinical trials for leiomyosarcoma demonstrate a diverse research landscape focused on improving treatment options for patients with advanced or metastatic disease. Three of the four trials are investigating treatments for patients whose cancer has already progressed after initial therapies, reflecting the significant need for effective second-line and beyond treatment options.
A notable concentration of trials is evident in Western Europe, with Germany, Italy, France, and Spain hosting multiple studies. One trial is specifically focused on leiomyosarcoma only, while three others include leiomyosarcoma as part of broader soft tissue sarcoma research. Trabectedin appears in three trials, either as a standalone treatment or in combination with other agents, highlighting its importance in current treatment approaches.
The trials employ various treatment strategies, including comparing different chemotherapy agents, testing combination therapies, evaluating neoadjuvant chemotherapy before surgery, and investigating novel intratumoral injection methods. These studies aim to improve disease-free survival, overall survival, and quality of life for patients with this challenging cancer. Patients interested in participating should discuss eligibility criteria with their healthcare providers, as requirements vary between studies regarding prior treatments, disease stage, and specific tumor characteristics.
Germany
