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

Non-interventional Study to Investigate Efficacy and Safety of Trabectedin (Yondelis®) in Patients With Advanced Soft Tissue Sarcoma

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.

Study Overview

• Status: Completed
• Conditions: Soft Tissue Sarcoma
• Intervention / Treatment: Drug: trabectedin

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 Type: Observational
• Enrollment (Actual): 130

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 13353
    • Charite - Universitatsmedizin Berlin
  • Bremen, Germany, 28209
    • Praxis für Innere Medizin, Hämatologie u. Onkologie
  • Hamburg, Germany, 20246
    • Universitatsklinikum Hamburg-Eppendorf
  • Hamburg, Germany, 20259
    • Onko-Kolleg GmbH & Co. KG - Überörtliche Gemeinschaftspraxis Dres. Verpoort, Wierecky, Zeller
  • Baden-Württemberg
    • Heidelberg, Baden-Württemberg, Germany, 69120
      • Universitätsklinikum Heidelberg
    • Stuttgart, Baden-Württemberg, Germany, 70174
      • Klinikum der Landeshauptstadt Stuttgart gKAöR - Klinik für Onkologie
  • Bayern
    • Augsburg, Bayern, Germany, 86156
      • Universitätsklinikum Augsburg A.d.ö.R - II. Medizinische Klinik
    • Donauwörth, Bayern, Germany, 86609
      • Onkologisches Zentrum Donauwörth
    • München, Bayern, Germany, 81377
      • LMU - Klinikum der Universität München - Medizinische Klinik und Poliklinik III/Hämatologie und Onkologie
    • Nürnberg, Bayern, Germany, 90419
      • Klinikum Nürnberg Nord - Medizinische Klinik 5, Schwerpunkt Onkologie/Hämatologie
    • Würzburg, Bayern, Germany, 97080
      • Universitätsklinikum Würzburg - Medizinische Klinik und Poliklinik II
  • Brandenburg
    • Bad Saarow, Brandenburg, Germany, 15526
      • Helios Klinikum Bad Saarow
  • Hessen
    • Wetzlar, Hessen, Germany, 35578
      • Lahn-Dill-Kliniken GmbH
  • Niedersachsen
    • Hannover, Niedersachsen, Germany, 30625
      • Medizinische Hochschule Hannover - Klinik für Hämatologie, Hämostaseologie, Onkologie und Stammzelltransplantation
    • Westerstede, Niedersachsen, Germany, 26655
      • Gemeinschaftspraxis Dr. Reichert, Dr. Janssen
    • Wilhelmshaven, Niedersachsen, Germany, 26389
      • Praxis Dr. Rodemer
  • Nordrhein-Westfalen
    • Wesel, Nordrhein-Westfalen, Germany, 46483
      • MVZ Marien-Hospital-Wesel GmbH
  • Sachsen-Anhalt
    • Magdeburg, Sachsen-Anhalt, Germany, 39120
      • Universitatsklinikum Magdeburg A.O.R.
  • Schleswig-Holstein
    • Lübeck, Schleswig-Holstein, Germany, 23538
      • Universitätsklinikum Schleswig-Holstein

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

100 patients (≥ 18 years) with advanced sarcoma after failure of anthracyclines and ifosfamide or patients unsuited to receive these drugs

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Drug: 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.; Other Names: Yondelis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
3 months progression free survival (PFS) rate	Number of patients without PD or death 3 months after start of therapy	3 months after start of therapy
6 months progression free survival (PFS) rate	Number of patients without PD or death 6 months after start of therapy	6 months after start of therapy

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: PharmaMar, Spain
• Investigators: Principal Investigator: Viktor Grünwald, Dr., Hannover Medical School

Study record dates

Study Major Dates

• Study Start (Actual): July 16, 2015
• Primary Completion (Actual): December 31, 2020
• Study Completion (Actual): December 31, 2020

Study Registration Dates

• First Submitted: February 4, 2015
• First Submitted That Met QC Criteria: February 13, 2015
• First Posted (Estimated): February 20, 2015

Study Record Updates

• Last Update Posted (Actual): June 22, 2023
• Last Update Submitted That Met QC Criteria: June 21, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Sarcoma; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Antineoplastic Agents, Alkylating; Alkylating Agents; Trabectedin
• Other Study ID Numbers: ET-D-023-13

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED