Retrospective Study in Sarcoma Patients

NCT ID: NCT03284320

Last Updated: 2021-11-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

514 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-04-18

Study Completion Date

2021-11-01

Brief Summary

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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.

Detailed Description

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Conditions

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Sarcoma of Bone Sarcoma of Soft Tissue

Keywords

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Drug therapy Treatment outcome Adult

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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PharmaMar

INDUSTRY

Sponsor Role collaborator

University Medicine Greifswald

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Daniel Pink, MD

Role: PRINCIPAL_INVESTIGATOR

University Medicine Greifswald

Peter Reichardt, MD

Role: PRINCIPAL_INVESTIGATOR

Sarcoma Center Berlin-Brandenburg; HELIOS Hospital Berlin Buch

Locations

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University Medicine Greifswald, Department of Internal Medicine C

Greifswald, , Germany

Site Status

Countries

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Germany

References

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Pink D, Bertz-Lepel J, Busemann C, Bitz U, Reichardt P. Efficacy of trabectedin in patients with advanced or metastatic alveolar soft-part sarcoma. Onkologie. 2012;35(5):249-52. doi: 10.1159/000338342. Epub 2012 Apr 23.

Reference Type BACKGROUND
PMID: 22868503 (View on PubMed)

Other Identifiers

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GISG-14

Identifier Type: -

Identifier Source: org_study_id