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
1 other identifier
observational
130
1 country
19
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jul 2015
Longer than P75 for all trials
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 4, 2015
CompletedFirst Posted
Study publicly available on registry
February 20, 2015
CompletedStudy Start
First participant enrolled
July 16, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2020
CompletedJune 22, 2023
June 1, 2023
5.5 years
February 4, 2015
June 21, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (7)
Tumor control rate
in average 6 months
3 and 6 months overall survival (OS) rate
3 and 6 months after start of therapy
Progression free survival (PFS)
in average 6 months
Type of treatment used
2 years
Treatment duration
from first cycle up to a maximum of 17 cycles, each cycle is 21 days (= 1 year)
- +2 more secondary outcomes
Study Arms (1)
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.
Interventions
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.
Eligibility Criteria
100 patients (≥ 18 years) with advanced sarcoma after failure of anthracyclines and ifosfamide or patients unsuited to receive these drugs
You may qualify if:
- 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
You may not qualify if:
- Patients presenting contraindications for the use of trabectedin as defined in the SmPC will be excluded from participating in the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- PharmaMar, Spainlead
Study Sites (19)
Universitätsklinikum Heidelberg
Heidelberg, Baden-Wurttemberg, 69120, Germany
Klinikum der Landeshauptstadt Stuttgart gKAöR - Klinik für Onkologie
Stuttgart, Baden-Wurttemberg, 70174, Germany
Universitätsklinikum Augsburg A.d.ö.R - II. Medizinische Klinik
Augsburg, Bavaria, 86156, Germany
Onkologisches Zentrum Donauwörth
Donauwörth, Bavaria, 86609, Germany
LMU - Klinikum der Universität München - Medizinische Klinik und Poliklinik III/Hämatologie und Onkologie
München, Bavaria, 81377, Germany
Klinikum Nürnberg Nord - Medizinische Klinik 5, Schwerpunkt Onkologie/Hämatologie
Nuremberg, Bavaria, 90419, Germany
Universitätsklinikum Würzburg - Medizinische Klinik und Poliklinik II
Würzburg, Bavaria, 97080, Germany
HELIOS Klinikum Bad Saarow
Bad Saarow, Brandenburg, 15526, Germany
Lahn-Dill-Kliniken GmbH
Wetzlar, Hesse, 35578, Germany
Medizinische Hochschule Hannover - Klinik für Hämatologie, Hämostaseologie, Onkologie und Stammzelltransplantation
Hanover, Lower Saxony, 30625, Germany
Gemeinschaftspraxis Dr. Reichert, Dr. Janssen
Westerstede, Lower Saxony, 26655, Germany
Praxis Dr. Rodemer
Wilhelmshaven, Lower Saxony, 26389, Germany
MVZ Marien-Hospital-Wesel GmbH
Wesel, North Rhine-Westphalia, 46483, Germany
Universitätsklinikum Magdeburg A.ö.R.
Magdeburg, Saxony-Anhalt, 39120, Germany
Universitätsklinikum Schleswig-Holstein
Lübeck, Schleswig-Holstein, 23538, Germany
Charité - Universitätsmedizin Berlin
Berlin, 13353, Germany
Praxis für Innere Medizin, Hämatologie u. Onkologie
Bremen, 28209, Germany
Universitätsklinikum Hamburg-Eppendorf
Hamburg, 20246, Germany
Onko-Kolleg GmbH & Co. KG - Überörtliche Gemeinschaftspraxis Dres. Verpoort, Wierecky, Zeller
Hamburg, 20259, Germany
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Viktor Grünwald, Dr.
Hannover Medical School
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 4, 2015
First Posted
February 20, 2015
Study Start
July 16, 2015
Primary Completion
December 31, 2020
Study Completion
December 31, 2020
Last Updated
June 22, 2023
Record last verified: 2023-06