Efficacy and Safety of Trabectedin (Yondelis®) in Patients With Advanced Soft Tissue Sarcoma

NCT ID: NCT02367924

Last Updated: 2023-06-22

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 130 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-07-16
• Study Completion Date: 2020-12-31

Brief Summary

Efficacy and safety of trabectedin in real-life practice, routinely used for the management of advanced sarcoma after failure of anthracyclines and ifosfamide or patients unsuited to receive these drugs in Germany.

Trabectedin is indicated for the treatment of patients with advanced soft tissue sarcoma, after failure of anthracyclines and ifosfamide, or who are unsuited to receive these agents. Efficacy data are based mainly on liposarcoma and leiomyosarcoma patients.

Detailed Description

This is a non-interventional, observational and prospective study to evaluate efficacy and safety of trabectedin in routine practice. Patients are assigned to a therapeutic strategy within current practice, not according to a trial protocol. The prescription of the medicine is separated from the decision to include the patient in the study. Diagnostic or monitoring procedures are only those ordinarily applied to the therapeutic strategy.

There are no dose regimens or medical procedures defined within this study plan. Every medical decision and course of treatment with trabectedin will reflect exclusively the decision of the Investigator in a routine clinical situation according to SmPC. The concept of this non-interventional study and its documentation procedure will not affect in any way the routine treatment situation.

Conditions

Soft Tissue Sarcoma

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

Yondelis

The administration of chemotherapy regimen with trabectedin (according to Summary of Product Characteristics (SmPC)) will be determined by the Investigator's discretion depending on the patients' conditions and previous chemotherapy.

trabectedin

Intervention Type: DRUG

The administration of chemotherapy regimen with trabectedin (according to Summary of Product Characteristics (SmPC)) will be determined by the Investigator's discretion depending on the patients' conditions and previous chemotherapy.

Interventions

trabectedin

The administration of chemotherapy regimen with trabectedin (according to Summary of Product Characteristics (SmPC)) will be determined by the Investigator's discretion depending on the patients' conditions and previous chemotherapy.

Intervention Type: DRUG

Other Intervention Names

Yondelis

Eligibility Criteria

Inclusion Criteria

• Patients must comply with all of the following criteria in order to be enrolled into the study:

• Histologically diagnosed advanced STS
• Female or male aged 18 years or above
• Signed written informed consent
• Suitable to undergo treatment with trabectedin according to SmPC
• Progress after therapy with anthracyclines and ifosfamide has failed, or if patients are unsuited to receive these agents

Exclusion Criteria

• Patients presenting contraindications for the use of trabectedin as defined in the SmPC will be excluded from participating in the study.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

PharmaMar, Spain

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Viktor Grünwald, Dr.

Role: PRINCIPAL_INVESTIGATOR

Hannover Medical School

Locations

Universitätsklinikum Heidelberg

Heidelberg, Baden-Wurttemberg, Germany

Klinikum der Landeshauptstadt Stuttgart gKAöR - Klinik für Onkologie

Stuttgart, Baden-Wurttemberg, Germany

Universitätsklinikum Augsburg A.d.ö.R - II. Medizinische Klinik

Augsburg, Bavaria, Germany

Onkologisches Zentrum Donauwörth

Donauwörth, Bavaria, Germany

LMU - Klinikum der Universität München - Medizinische Klinik und Poliklinik III/Hämatologie und Onkologie

München, Bavaria, Germany

Klinikum Nürnberg Nord - Medizinische Klinik 5, Schwerpunkt Onkologie/Hämatologie

Nuremberg, Bavaria, Germany

Universitätsklinikum Würzburg - Medizinische Klinik und Poliklinik II

Würzburg, Bavaria, Germany

HELIOS Klinikum Bad Saarow

Bad Saarow, Brandenburg, Germany

Lahn-Dill-Kliniken GmbH

Wetzlar, Hesse, Germany

Medizinische Hochschule Hannover - Klinik für Hämatologie, Hämostaseologie, Onkologie und Stammzelltransplantation

Hanover, Lower Saxony, Germany

Gemeinschaftspraxis Dr. Reichert, Dr. Janssen

Westerstede, Lower Saxony, Germany

Praxis Dr. Rodemer

Wilhelmshaven, Lower Saxony, Germany

MVZ Marien-Hospital-Wesel GmbH

Wesel, North Rhine-Westphalia, Germany

Universitätsklinikum Magdeburg A.ö.R.

Magdeburg, Saxony-Anhalt, Germany

Universitätsklinikum Schleswig-Holstein

Lübeck, Schleswig-Holstein, Germany

Charité - Universitätsmedizin Berlin

Berlin, , Germany

Praxis für Innere Medizin, Hämatologie u. Onkologie

Bremen, , Germany

Universitätsklinikum Hamburg-Eppendorf

Hamburg, , Germany

Onko-Kolleg GmbH & Co. KG - Überörtliche Gemeinschaftspraxis Dres. Verpoort, Wierecky, Zeller

Hamburg, , Germany

Countries

Germany

Other Identifiers

ET-D-023-13

Identifier Type: -

Identifier Source: org_study_id