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

Soft Tissue Sarcoma Clinical Trial

— YonSar  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02367924
• Other study ID #: ET-D-023-13
• Status: Completed
• Start date: July 16, 2015
• Est. completion date: December 31, 2020

Study information

• Verified date: June 2023
• Source: PharmaMar, Spain
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Sarcoma
• Soft Tissue Sarcoma

Intervention

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.

Locations

Country	Name	City	State
Germany	Universitätsklinikum Augsburg A.d.ö.R - II. Medizinische Klinik	Augsburg	Bayern
Germany	HELIOS Klinikum Bad Saarow	Bad Saarow	Brandenburg
Germany	Charité - Universitätsmedizin Berlin	Berlin
Germany	Praxis für Innere Medizin, Hämatologie u. Onkologie	Bremen
Germany	Onkologisches Zentrum Donauwörth	Donauwörth	Bayern
Germany	Onko-Kolleg GmbH & Co. KG - Überörtliche Gemeinschaftspraxis Dres. Verpoort, Wierecky, Zeller	Hamburg
Germany	Universitätsklinikum Hamburg-Eppendorf	Hamburg
Germany	Medizinische Hochschule Hannover - Klinik für Hämatologie, Hämostaseologie, Onkologie und Stammzelltransplantation	Hannover	Niedersachsen
Germany	Universitätsklinikum Heidelberg	Heidelberg	Baden-Württemberg
Germany	Universitätsklinikum Schleswig-Holstein	Lübeck	Schleswig-Holstein
Germany	Universitätsklinikum Magdeburg A.ö.R.	Magdeburg	Sachsen-Anhalt
Germany	LMU - Klinikum der Universität München - Medizinische Klinik und Poliklinik III/Hämatologie und Onkologie	München	Bayern
Germany	Klinikum Nürnberg Nord - Medizinische Klinik 5, Schwerpunkt Onkologie/Hämatologie	Nürnberg	Bayern
Germany	Klinikum der Landeshauptstadt Stuttgart gKAöR - Klinik für Onkologie	Stuttgart	Baden-Württemberg
Germany	MVZ Marien-Hospital-Wesel GmbH	Wesel	Nordrhein-Westfalen
Germany	Gemeinschaftspraxis Dr. Reichert, Dr. Janssen	Westerstede	Niedersachsen
Germany	Lahn-Dill-Kliniken GmbH	Wetzlar	Hessen
Germany	Praxis Dr. Rodemer	Wilhelmshaven	Niedersachsen
Germany	Universitätsklinikum Würzburg - Medizinische Klinik und Poliklinik II	Würzburg	Bayern

Sponsors (1)

Lead Sponsor	Collaborator
PharmaMar, Spain

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Tumor control rate	Best response (CR+PR+Disease stabilization) according to institutional standards	in average 6 months
Secondary	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
Secondary	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
Secondary	Type of treatment used	dose reductions and postponement of cycles	2 years
Secondary	Treatment duration	Number of cycles	from first cycle up to a maximum of 17 cycles, each cycle is 21 days (= 1 year)
Secondary	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)
Secondary	General description of grade 3/4 adverse events	Adverse events of grade 3/4 according to NCI CTC V4	2 years