Clinical trial NCT02367924: Efficacy and Safety of Trabectedin (Yondelis®) in Patients With Advanced Soft Tissue Sarcoma
Official title: Non-interventional Study to Investigate Efficacy and Safety of Trabectedin (Yondelis®) in Patients With Advanced Soft Tissue Sarcoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Soft Tissue Sarcoma
Lead sponsor: PharmaMar, Spain
Sponsor class: INDUSTRY
First posted: 2015-02-20
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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

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.

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.

Primary outcomes:
measure: 3 months progression free survival (PFS) rate
timeFrame: 3 months after start of therapy
measure: 6 months progression free survival (PFS) rate
timeFrame: 6 months after start of therapy
Secondary outcomes:
measure: Tumor control rate
timeFrame: in average 6 months
measure: 3 and 6 months overall survival (OS) rate
timeFrame: 3 and 6 months after start of therapy
measure: Progression free survival (PFS)
timeFrame: in average 6 months
measure: Type of treatment used
timeFrame: 2 years
measure: Treatment duration
timeFrame: from first cycle up to a maximum of 17 cycles, each cycle is 21 days (= 1 year)
measure: Reason for discontinuation of trabectedin treatment
timeFrame: from first cycle up to a maximum of 17 cycles, each cycle is 21 days (= 1 year)
measure: General description of grade 3/4 adverse events
timeFrame: 2 years
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: Universitätsklinikum Heidelberg
state: Baden-Württemberg
city: Stuttgart
country: Germany
facility: Klinikum der Landeshauptstadt Stuttgart gKAöR - Klinik für Onkologie
state: Baden-Württemberg
city: Augsburg
country: Germany
facility: Universitätsklinikum Augsburg A.d.ö.R - II. Medizinische Klinik
state: Bayern
city: Donauwörth
country: Germany
facility: Onkologisches Zentrum Donauwörth
state: Bayern
city: München
country: Germany
facility: LMU - Klinikum der Universität München - Medizinische Klinik und Poliklinik III/Hämatologie und Onkologie
state: Bayern
city: Nürnberg
country: Germany
facility: Klinikum Nürnberg Nord - Medizinische Klinik 5, Schwerpunkt Onkologie/Hämatologie
state: Bayern
city: Würzburg
country: Germany
facility: Universitätsklinikum Würzburg - Medizinische Klinik und Poliklinik II
state: Bayern
city: Bad Saarow
country: Germany
facility: HELIOS Klinikum Bad Saarow
state: Brandenburg
city: Wetzlar
country: Germany
facility: Lahn-Dill-Kliniken GmbH
state: Hessen
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover - Klinik für Hämatologie, Hämostaseologie, Onkologie und Stammzelltransplantation
state: Niedersachsen
city: Westerstede
country: Germany
facility: Gemeinschaftspraxis Dr. Reichert, Dr. Janssen
state: Niedersachsen
city: Wilhelmshaven
country: Germany
facility: Praxis Dr. Rodemer
state: Niedersachsen
city: Wesel
country: Germany
facility: MVZ Marien-Hospital-Wesel GmbH
state: Nordrhein-Westfalen
city: Magdeburg
country: Germany
facility: Universitätsklinikum Magdeburg A.ö.R.
state: Sachsen-Anhalt
city: Lübeck
country: Germany
facility: Universitätsklinikum Schleswig-Holstein
state: Schleswig-Holstein
city: Berlin
country: Germany
facility: Charité - Universitätsmedizin Berlin
city: Bremen
country: Germany
facility: Praxis für Innere Medizin, Hämatologie u. Onkologie
city: Hamburg
country: Germany
facility: Universitätsklinikum Hamburg-Eppendorf
city: Hamburg
country: Germany
facility: Onko-Kolleg GmbH & Co. KG - Überörtliche Gemeinschaftspraxis Dres. Verpoort, Wierecky, Zeller
Study officials:
affiliation: Hannover Medical School
name: Viktor Grünwald, Dr.
role: PRINCIPAL_INVESTIGATOR
References: