BZKF-Register zu metastasierten WeichteilsarkomenRecruiting

Long-term observational study on the disease course of patients with newly diagnosed metastatic soft tissue sarcoma

Gender
Women and men
Age
18 years and older
Trial type
Observational
Line of therapy
First line
Phase

What is this trial about?

The treatment of metastatic soft tissue sarcoma poses a challenge. Therefore, long-term data on the various therapeutic approaches for this rare disease are needed. The goal of the Metastatic Soft Tissue Sarcoma Registry is to monitor and systematically record the course of the disease in patients over an extended period of time in order to identify prognostic clinical factors for treatment. Eligible participants include women and men aged 18 and older who have been diagnosed with soft tissue sarcoma with newly diagnosed distant metastases.

Trial flow

Requirements

Diagnosis: Soft tissue sarcoma

Age: 18 years and older

Line of therapy: Erstlinie / bisher keine Therapie

Key inclusion criteria: Newly diagnosed first-time distant metastasis; no gastrointestinal stromal tumours (GIST), Ewing sarcomas, small cell, blue cell, round cell sarcomas and rhabdomyosarcomas

Allocation

Einarmige Studie

Treatment

approx. 104 weeks
Observational studyLong-term systematic recording of the course of the disease under the various therapeutic approaches for at least 2 years.

Follow-up

24 months

Detailed description

Soft tissue sarcoma is an umbrella term for various malignant diseases of connective, muscle, or fatty tissue in which uncontrolled cell proliferation occurs. They are relatively rare and can occur anywhere in the body. The causes are usually unknown but may be genetic or environmental. If the disease is not detected until the metastatic stage—that is, when the tumor has spread to other organs—treatment is more difficult and the prognosis is poorer. The risk of metastasis varies depending on the type of soft tissue sarcoma. The standard treatment for metastatic soft tissue sarcoma usually consists of systemic chemotherapy, in which drugs act throughout the body, as well as locally targeted treatments such as surgery or radiation therapy directed at the metastases. There are many different subtypes of soft tissue sarcomas, which grow at different rates and respond differently to treatment. The precise selection of therapy is very complex and depends on numerous factors.

The goal of this prospective registry study is to monitor and document the long-term course of the disease in order to identify clinical factors that are significant for treatment. The study is purely observational and prospective, which means that no drugs or new forms of therapy are being tested. Patients will be monitored over an extended period (at least 2 years) to assess the long-term effects of the treatments. The primary endpoint of the study is progression-free survival (PFS), defined as the time from the start of the study until the first occurrence of disease progression, recurrence, or death from any cause.

Women and men aged 18 and older with soft tissue sarcoma and newly diagnosed distant metastases are eligible to participate in this study. Certain subtypes, such as gastrointestinal stromal tumors (GIST), Ewing sarcomas, small-cell, blue-cell, and round-cell sarcomas, and rhabdomyosarcomas, are excluded.

Facts

  1. Disease: Soft tissue sarcoma
  2. Cancer characteristics: Newly diagnosed first distant metastasis
  3. What the study investigates: Monitoring the course of the disease and systematic data collection in real-world clinical practice
  4. Study objective: Identification of prognostic clinical factors for treatment
  5. Study duration: Follow-up for at least 2 years
  6. Study characteristics: Prospective observational study; no medications or new forms of therapy are being tested

Trial sites

8 trial sites in Germany are listed. Find a site near you.

  • Universitätsklinikum Augsburg

    Stenglinstraße 2, 86156 Augsburg

    Recruiting
  • Universitätsklinikum Erlangen

    Erlangen

    Active, not recruiting
  • Universitätsklinikum Frankfurt

    Frankfurt am Main

    Recruiting
  • Klinikum rechts der Isar der Technischen Universität München

    München

    Recruiting
  • Ludwig-Maximilians-Universität München

    Munich

    Status unknown
  • Universitätsklinikum Regensburg

    Regensburg

    Status unknown

This list is compiled to the best of our knowledge but without guarantee: it may be incomplete, and a site's recruitment status can change at any time.

Medical editorial team

  • Dr. med. Sebastian SommerSpecialist in internal medicine with a focus on hematology and oncology
  • PD Dr. med. Matthias FröhlichSpecialist in internal medicine, immunology and emergency medicine

This description was translated into plain language by our medical editorial team. Whether participation is an option for you is a decision you make together with your treating physician.