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OpenTrials
Completed

NCT Number: NCT03284320

Retrospective Study in Sarcoma Patients

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.

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Key information

Conditions

Sarcoma of Bone Neoplasms Neoplasms by Histologic Type Neoplasms, Bone Tissue Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Osteosarcoma Sarcoma Sarcoma of Soft Tissue

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Medicine Greifswald, Department of Internal Medicine C

Greifswald, 17475, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University Medicine Greifswald

Other

Collaborators

  • PharmaMar

Registry information

Official study title

Retrospective Study to Evaluate Efficacy and Safety of Trabectedin (Yondelis®) in Sarcoma Patients

Acronym: ReTraSarc

Important dates

Study start
2017
Primary completion
2019
Study completion
2021
First posted
Sep 15, 2017
Registry last updated
Nov 15, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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