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Geriatric Assessmen of Elderly "Unsuited" Patients Receiving Trabectedin in First Line Treatment For Advanced Soft Tissue Sarcomas (STS) (E-TRAB)

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ClinicalTrials.gov Identifier: NCT03022448
Recruitment Status : Recruiting
First Posted : January 16, 2017
Last Update Posted : October 23, 2018
Sponsor:
Information provided by (Responsible Party):
GWT-TUD GmbH

Study Description
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Brief Summary:

The aim of the non-interventional study is to prospectively collect and analyze data on the geriatric assessment of patients undergoing systemic 1st line therapy with trabectedin with focus on patients who have been assessed by the treating physician as being unsuited to receive standard chemotherapy with anthracyclines and / or ifosfamide.

Trabectedin will be used according to the local SmPC. Modification of the treatment schedule should follow the standard medical practice at the discretion of the treating physician and is not part of this Observational Plan.


Condition or disease Intervention/treatment
Advanced Soft-tissue Sarcoma Metastatic Soft-tissue Sarcoma Other: No Intervention

Study Design
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Study Type : Observational
Estimated Enrollment : 110 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Geriatric Assessmen of Elderly "Unsuited" Patients Receiving Trabectedin in First Line Treatment For Advanced Soft Tissue Sarcomas (STS)
Actual Study Start Date : January 2017
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Trabectedin

Groups and Cohorts
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Group/Cohort Intervention/treatment
Treatment Group
Trabectedin will be used according to the local SmPC. Modification of the treatment schedule should follow the standard medical practice at the discretion of the treating physician and is not part of this Observational Plan.
 Other: No Intervention
This is a NIS. No intervention.


Outcome Measures
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Primary Outcome Measures :
  1. Overall survival [ Time Frame: 12 month after LPFV ]
    Overall survival for each patient will be followed until the end of the study that is defined by 12 months after inclusion of the last patient.


Eligibility Criteria
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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Elderly patients with advanced and/or metastatic STS (≥ 60 years including a maximum of 1/6 of "unsuited" patients younger than 60 years)
Criteria

Inclusion Criteria:

Written informed consent

  • Age of ≥ 60 years at study inclusion with a limited number of "unsuited" patients younger than 60 years
  • Histologically proven advanced and/or metastatic STS, intermediate/high grade
  • Presence of measurable disease according to RECIST 1.1. (optional, according to local clinical practice)
  • Patients indicated for 1st line treatment with trabectedin according to local SmPC
  • ECOG Performance Status 0, 1 or 2
  • bone marrow function according to local SmPC
  • hepatic function according to local SmPC
  • Ability to understand and follow study-related instructions

Exclusion Criteria:

  • Histologically proven advanced and/or metastatic STS of the following tumor types:
  • Embryonal rhabdomyosarcoma
  • Chondrosarcoma (excluding extraskeletal myxoid chondrosarcoma)
  • Osteosarcoma (excluding extraskeletal osteosarcoma)
  • Ewing tumors/primitive neuroectodermal tumor
  • Gastrointestinal stromal tumors
  • Dermatofibrosarcoma protuberans
  • Use of any investigational agent within 28 days prior to treatment start
  • Exclusion periods from other studies or simultaneous participation in other clinical studies
  • Contraindications according to the local SmPC of Yondelis® (see Appendix A)
  • Subject is in custody by order of an authority or a court of law
  • Previous assignment to the E-Trab study (An individual subject may only be included once in the study)
  • Criteria which in the opinion of the investigator preclude participation for scientific reasons, for reasons of compliance, or for reasons of the subject's safety
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03022448


Contacts
Contact: Martin Puttrich +49 (0) 351 25933 193 Martin.Puttrich@gwtonline.de

Locations
Austria
Klinikum Klagenfurt am Wörthersee Recruiting
Klagenfurt, Austria
Contact: Wolfgang Eisterer, Prof. Dr.         
Medizinische Universität Wien Recruiting
Wien, Austria
Contact: Thomas Brodowicz, Prof. Dr.         
Germany
HELIOS Klinikum Bad Saarow Recruiting
Bad Saarow, Germany
Contact: Daniel Pink, Dr.         
HELIOS Klinikum Berlin Buch Recruiting
Berlin, Germany
Contact: Peter Reichardt, PD         
Klinikum Spandau Recruiting
Berlin, Germany
Contact: Annegret Kunitz, Dr.         
Universitätsklinikum Carl Gustav Carus der TU Dresden Recruiting
Dresden, Germany
Contact: Stephan Richter, Dr.         
Universitätsklinikum Heidelberg Recruiting
Heidelberg, Germany
Contact: Gerlinde Egerer, Prof. Dr.         
University of Heidelberg Mannheim University Medical Center Interdisciplinary Tumor Center, Sarcoma Unit Recruiting
Mannheim, Germany
Contact: Bernd Kasper, Prof.    +49 621 383 2580    bernd.kasper@umm.de   
Klinikum Nürnberg Nord Recruiting
Nürnberg, Germany
Contact: Marinela Augustin, Dr.         
Universitätsklinikum Ulm Recruiting
Ulm, Germany
Contact: Verena Gaidzik, Dr.         
Switzerland
Universitätsspital Bern Recruiting
Bern, Switzerland
Contact: Attila Kollar, Dr. med.         
Kantonsspital St. Gallen Recruiting
Saint Gallen, Switzerland
Contact: Christian Rothermundt, Dr.         
Sponsors and Collaborators
GWT-TUD GmbH
Investigators
Principal Investigator: Bernd Kasper, Prof. University of Heidelberg Mannheim University Medical Center Interdisciplinary Tumor Center, Sarcoma Unit
More Information
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Responsible Party: GWT-TUD GmbH
ClinicalTrials.gov Identifier: NCT03022448     History of Changes
Other Study ID Numbers: E-Trab
First Posted: January 16, 2017    Key Record Dates
Last Update Posted: October 23, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by GWT-TUD GmbH:
soft tissue sarcomas (STS)
trabectedin
metastatic STS patients
overall survival

Additional relevant MeSH terms:
Sarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Trabectedin
 Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents