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

Completed

• Conditions: Soft Tissue Sarcoma
• Interventions: Drug: trabectedin

• Registration Number: NCT02367924
• Lead Sponsor: PharmaMar, Spain

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.

Study Timeline

• Study First Submitted: 2015-02-04
• Study First Submitted QC: 2015-02-13
• Study First Posted: 2015-02-20
• Study Start: 2015-07-16
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-21
• Last Update Posted: 2023-06-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 130

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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Yondelis	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.

Primary Outcome Measures

Name	Time	Method
3 months progression free survival (PFS) rate	3 months after start of therapy	Number of patients without PD or death 3 months after start of therapy
6 months progression free survival (PFS) rate	6 months after start of therapy	Number of patients without PD or death 6 months after start of therapy

Secondary Outcome Measures

Name	Time	Method
Type of treatment used	2 years	dose reductions and postponement of cycles
Tumor control rate	in average 6 months	Best response (CR+PR+Disease stabilization) according to institutional standards
General description of grade 3/4 adverse events	2 years	Adverse events of grade 3/4 according to NCI CTC V4
Reason for discontinuation of trabectedin treatment	from first cycle up to a maximum of 17 cycles, each cycle is 21 days (= 1 year)	Analysis of documented reasons
Progression free survival (PFS)	in average 6 months	Time from start of therapy to the date of documented PD or death (death of any cause)
Treatment duration	from first cycle up to a maximum of 17 cycles, each cycle is 21 days (= 1 year)	Number of cycles
3 and 6 months overall survival (OS) rate	3 and 6 months after start of therapy	Number of patients alive after 3 months and 6 months

Trial Locations

Locations (19)

Medizinische Hochschule Hannover - Klinik für Hämatologie, Hämostaseologie, Onkologie und Stammzelltransplantation; 🇩🇪 Hannover, Niedersachsen, Germany

Gemeinschaftspraxis Dr. Reichert, Dr. Janssen; 🇩🇪 Westerstede, Niedersachsen, Germany

Onkologisches Zentrum Donauwörth; 🇩🇪 Donauwörth, Bayern, Germany

Universitätsklinikum Würzburg - Medizinische Klinik und Poliklinik II; 🇩🇪 Würzburg, Bayern, Germany

Universitätsklinikum Schleswig-Holstein; 🇩🇪 Lübeck, Schleswig-Holstein, Germany

Praxis für Innere Medizin, Hämatologie u. Onkologie; 🇩🇪 Bremen, Germany

Onko-Kolleg GmbH & Co. KG - Überörtliche Gemeinschaftspraxis Dres. Verpoort, Wierecky, Zeller; 🇩🇪 Hamburg, Germany

Klinikum der Landeshauptstadt Stuttgart gKAöR - Klinik für Onkologie; 🇩🇪 Stuttgart, Baden-Württemberg, Germany

HELIOS Klinikum Bad Saarow; 🇩🇪 Bad Saarow, Brandenburg, Germany

Praxis Dr. Rodemer; 🇩🇪 Wilhelmshaven, Niedersachsen, Germany

Universitätsklinikum Hamburg-Eppendorf; 🇩🇪 Hamburg, Germany

Universitätsklinikum Augsburg A.d.ö.R - II. Medizinische Klinik; 🇩🇪 Augsburg, Bayern, Germany

LMU - Klinikum der Universität München - Medizinische Klinik und Poliklinik III/Hämatologie und Onkologie; 🇩🇪 München, Bayern, Germany

MVZ Marien-Hospital-Wesel GmbH; 🇩🇪 Wesel, Nordrhein-Westfalen, Germany

Lahn-Dill-Kliniken GmbH; 🇩🇪 Wetzlar, Hessen, Germany

Klinikum Nürnberg Nord - Medizinische Klinik 5, Schwerpunkt Onkologie/Hämatologie; 🇩🇪 Nürnberg, Bayern, Germany

Universitätsklinikum Magdeburg A.ö.R.; 🇩🇪 Magdeburg, Sachsen-Anhalt, Germany

Charité - Universitätsmedizin Berlin; 🇩🇪 Berlin, Germany

Universitätsklinikum Heidelberg; 🇩🇪 Heidelberg, Baden-Württemberg, Germany