Sarcoma of BoneReTraSarcNCT03284320
Retrospective Study in Sarcoma Patients
An observational study of Sarcoma of Bone and Sarcoma of Soft Tissue, run by University Medicine Greifswald at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sarcoma of Bone, Sarcoma of Soft Tissue
- How many people
- 514 participants
- Where
- 1 siteGermany
- Study dates
- 18 Apr 2017to 1 Nov 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with soft tissue and bone sarcomas treated with Trabectedin
Who may be able to join
- 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
Who cannot join
- No follow-up data available
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Medicine Greifswald, Department of Internal Medicine C
Greifswald, 17475
About this study
Official title: Retrospective Study to Evaluate Efficacy and Safety of Trabectedin (Yondelis®) 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.
- Conditions
- Sarcoma of Bone, Sarcoma of Soft Tissue
- Keywords
- Drug therapy, Treatment outcome, Adult
- Medical subject headings
- Osteosarcoma, Sarcoma
What is being measured
The primary outcome is the main question the study is designed to answer.
- Progression free survival (PFS)
Measured: At the time of every treatment documentation up to the end of treatment, approximately 2 years
- Overall survival (OS)
Measured: 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
Safety Evaluation according to toxitiy
Measured: At the time of every treatment documentation up to the end of treatment, approximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2017
- Study start18 Apr 2017
- Primary completion31 Dec 2019
- Study completion1 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sarcoma of BoneStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 514 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medicine Greifswald
- Sponsor type
- University, hospital or other
- Collaborators
- PharmaMar
- Responsible party
- Sponsor
- Investigators
- Daniel Pink, MD, Principal investigator, University Medicine GreifswaldPeter Reichardt, MD, Principal investigator, Sarcoma Center Berlin-Brandenburg; HELIOS Hospital Berlin Buch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03284320
- Sponsor's protocol ID
- GISG-14
- Acronym
- ReTraSarc
- Status last verified
- Nov 2021
- First submitted
- 21 Aug 2017
- Last updated
- 15 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 22868503
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Study to Evaluate Efficacy and Safety of Trabectedin (Yondelis®) in Sarcoma Patients
- ClinicalTrials.gov ID
- NCT03284320
- Acronym / sponsor ID
- ReTraSarc / GISG-14
- Conditions
- Sarcoma of Bone, Sarcoma of Soft Tissue
- Keywords
- Drug therapy, Treatment outcome, Adult
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 514 participants (actual)
- Lead sponsor
- University Medicine GreifswaldUniversity, hospital or other
- Collaborators
- PharmaMar
- Study start
- 18 Apr 2017 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 1 Nov 2021 (actual)
- First posted
- 15 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with soft tissue and bone sarcomas treated with Trabectedin
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- No follow-up data available
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
- Progression free survival (PFS)
Time frame: At the time of every treatment documentation up to the end of treatment, approximately 2 years
- Overall survival (OS)
Time frame: At the time of every treatment documentation up to the end of treatment, approximately 2 years
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2021.
- Background: PubMed 22868503Pink 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Pink, MD principal investigator
University Medicine Greifswald
Peter Reichardt, MD principal investigator
Sarcoma Center Berlin-Brandenburg; HELIOS Hospital Berlin Buch
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sarcoma of Bone and Sarcoma of Soft Tissue, run by University Medicine Greifswald at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
- Progression free survival (PFS) (time frame: At the time of every treatment documentation up to the end of treatment, approximately 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03284320, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2021; AzTrials last refreshed its copy on 27 Oct 2026.