NCT03284320

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
514

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

April 18, 2017

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 21, 2017

Completed
25 days until next milestone

First Posted

Study publicly available on registry

September 15, 2017

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2021

Completed
Last Updated

November 15, 2021

Status Verified

November 1, 2021

Enrollment Period

2.7 years

First QC Date

August 21, 2017

Last Update Submit

November 5, 2021

Conditions

Sarcoma of BoneSarcoma of Soft Tissue

Keywords

Drug therapyTreatment outcomeAdult

Outcome Measures

Primary Outcomes (2)

  • - Progression free survival (PFS)

    At the time of every treatment documentation up to the end of treatment, approximately 2 years

  • - Overall survival (OS)

    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

    At the time of every treatment documentation up to the end of treatment, approximately 2 years

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with soft tissue and bone sarcomas treated with Trabectedin

You may qualify if:

  • 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

You may not qualify if:

  • No follow-up data available

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medicine Greifswald, Department of Internal Medicine C

Greifswald, 17475, Germany

Location

Related Publications (1)

  • 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.

    PMID: 22868503BACKGROUND

MeSH Terms

Conditions

OsteosarcomaSarcoma

Condition Hierarchy (Ancestors)

Neoplasms, Bone TissueNeoplasms, Connective TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasms

Study Officials

  • Daniel Pink, MD

    University Medicine Greifswald

    PRINCIPAL INVESTIGATOR

  • Peter Reichardt, MD

    Sarcoma Center Berlin-Brandenburg; HELIOS Hospital Berlin Buch

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 21, 2017

First Posted

September 15, 2017

Study Start

April 18, 2017

Primary Completion

December 31, 2019

Study Completion

November 1, 2021

Last Updated

November 15, 2021

Record last verified: 2021-11

Locations

DE(1)