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Retrospective Study in Sarcoma Patients (ReTraSarc)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03284320
Recruitment Status : Active, not recruiting
First Posted : September 15, 2017
Last Update Posted : February 4, 2019
Sponsor:
Collaborator:
PharmaMar
Information provided by (Responsible Party):
University Medicine Greifswald

Brief Summary:
The objectives of this trial is to evaluate efficacy and safety of treatment with Trabectedin in a large cohort of German patients with soft tissue and bone sarcomas.

Condition or disease
Sarcoma of Bone Sarcoma of Soft Tissue Drug Therapy Treatment Outcome Adult

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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Retrospective Study to Evaluate Efficacy and Safety of Trabectedin (Yondelis®) in Sarcoma Patients
Actual Study Start Date : April 18, 2017
Actual Primary Completion Date : December 31, 2018
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. - Progression free survival (PFS) [ Time Frame: At the time of every treatment documentation up to the end of treatment, approximately 2 years ]
  2. - Overall survival (OS) [ Time Frame: At the time of every treatment documentation up to the end of treatment, approximately 2 years ]

Secondary Outcome Measures :
  1. CTCAE (Common Terminology Criteria for Adverse Events) 4.03 [ Time Frame: At the time of every treatment documentation up to the end of treatment, approximately 2 years ]
    Safety Evaluation according to toxitiy



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with soft tissue and bone sarcomas treated with Trabectedin
Criteria

Inclusion Criteria:

  • Patients with histologically confirmed soft tissue or bone sarcomas treated with at least one cycle of Trabectedin in any line of therapy.
  • Age ≥18years at start of therapy with Trabectedin
  • Informed Consent
  • Patients already deceased may be included when the treating physician is able to determine the presumptive consent

Exclusion Criteria:

  • No follow-up data available

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): NCT03284320


Locations
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Germany
University Medicine Greifswald, Department of Internal Medicine C
Greifswald, Germany, 17475
Sponsors and Collaborators
University Medicine Greifswald
PharmaMar
Investigators
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Principal Investigator: Daniel Pink, MD University Medicine Greifswald
Principal Investigator: Peter Reichardt, MD Sarcoma Center Berlin-Brandenburg; HELIOS Hospital Berlin Buch

Publications:
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Responsible Party: University Medicine Greifswald
ClinicalTrials.gov Identifier: NCT03284320     History of Changes
Other Study ID Numbers: GISG-14
First Posted: September 15, 2017    Key Record Dates
Last Update Posted: February 4, 2019
Last Verified: October 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Sarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms