Advanced Soft-tissue SarcomaE-TRABNCT03022448
Geriatric Assessmen of Elderly "Unsuited" Patients Receiving Trabectedin in First Line Treatment For Advanced Soft Tissue Sarcomas (STS)
An observational study of Advanced Soft-tissue Sarcoma and Metastatic Soft-tissue Sarcoma, run by GWT-TUD GmbH at 12 sites in 3 countries.
Trial summary
The aim of the non-interventional study is to prospectively collect and analyze data on the geriatric assessment of patients undergoing systemic 1st line therapy with trabectedin with focus on patients who have been assessed by the treating physician as being unsuited to receive standard chemotherapy with… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Advanced Soft-tissue Sarcoma, Metastatic Soft-tissue Sarcoma
- How many people
- 72 participants
- Where
- 12 sitesin 3 countries
- Study dates
- 2 Feb 2017to 31 Dec 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Elderly patients with advanced and/or metastatic STS (≥ 60 years including a maximum of 1/6 of "unsuited" patients younger than 60 years)
Who may be able to join
- Written informed consent
- Age of ≥ 60 years at study inclusion with a limited number of "unsuited" patients younger than 60 years
- Histologically proven advanced and/or metastatic STS, intermediate/high grade
- Presence of measurable disease according to RECIST 1.1. (optional, according to local clinical practice)
- Patients indicated for 1st line treatment with trabectedin according to local SmPC
- ECOG Performance Status 0, 1 or 2
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- bone marrow function according to local SmPC
- hepatic function according to local SmPC
- Ability to understand and follow study-related instructions
Who cannot join
- Histologically proven advanced and/or metastatic STS of the following tumor types:
- Embryonal rhabdomyosarcoma
- Chondrosarcoma (excluding extraskeletal myxoid chondrosarcoma)
- Osteosarcoma (excluding extraskeletal osteosarcoma)
- Ewing tumors/primitive neuroectodermal tumor
- Gastrointestinal stromal tumors
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- Dermatofibrosarcoma protuberans
- Use of any investigational agent within 28 days prior to treatment start
- Exclusion periods from other studies or simultaneous participation in other clinical studies
- Contraindications according to the local SmPC of Yondelis® (see Appendix A)
- Subject is in custody by order of an authority or a court of law
- Previous assignment to the E-Trab study (An individual subject may only be included once in the study)
- Criteria which in the opinion of the investigator preclude participation for scientific reasons, for reasons of compliance, or for reasons of the subject's safety
Trial locations and contacts
12 sites in 3 countries.
12 sites in 3 countries
Germany8 sites
HELIOS Klinikum Bad Saarow
Bad Saarow
HELIOS Klinikum Berlin Buch
Berlin
Klinikum Spandau
Berlin
Universitätsklinikum Carl Gustav Carus der TU Dresden
Dresden
Universitätsklinikum Heidelberg
Heidelberg
University of Heidelberg Mannheim University Medical Center Interdisciplinary Tumor Center, Sarcoma Unit
Mannheim
Klinikum Nürnberg Nord
Nuremberg
Universitätsklinikum Ulm
Ulm
Austria2 sites
Klinikum Klagenfurt am Wörthersee
Klagenfurt
Medizinische Universität Wien
Vienna
Switzerland2 sites
Universitätsspital Bern
Bern
Kantonsspital St. Gallen
Sankt Gallen
About this study
The aim of the non-interventional study is to prospectively collect and analyze data on the geriatric assessment of patients undergoing systemic 1st line therapy with trabectedin with focus on patients who have been assessed by the treating physician as being unsuited to receive standard chemotherapy with anthracyclines and / or ifosfamide.
Trabectedin will be used according to the local SmPC. Modification of the treatment schedule should follow the standard medical practice at the discretion of the treating physician and is not part of this Observational Plan.
- Being tested
- No Intervention
- Keywords
- soft tissue sarcomas (STS), trabectedin, metastatic STS patients, overall survival
- Medical subject headings
- Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No InterventionOther
This is a NIS. No intervention.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Trabectedin will be used according to the local SmPC. Modification of the treatment schedule should follow the standard medical practice at the discretion of the treating physician and is not part of this Observational Plan. Receives: Other: No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Overall survival for each patient will be followed until the end of the study that is defined by 12 months after inclusion of the last patient.
Measured: 12 month after LPFV
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2017 (estimated)
- Study start2 Feb 2017
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Soft-tissue SarcomaStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- GWT-TUD GmbH
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bernd Kasper, Prof., Principal investigator, University of Heidelberg Mannheim University Medical Center Interdisciplinary Tumor Center, Sarcoma Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03022448
- Sponsor's protocol ID
- E-Trab
- Acronym
- E-TRAB
- Status last verified
- Apr 2022
- First submitted
- 13 Jan 2017
- Last updated
- 4 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Geriatric Assessmen of Elderly "Unsuited" Patients Receiving Trabectedin in First Line Treatment For Advanced Soft Tissue Sarcomas (STS)
- ClinicalTrials.gov ID
- NCT03022448
- Acronym / sponsor ID
- E-TRAB / E-Trab
- Keywords
- soft tissue sarcomas (STS), trabectedin, metastatic STS patients, overall survival
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- GWT-TUD GmbHUniversity, hospital or other
- Study start
- 2 Feb 2017 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 16 Jan 2017 (estimated)
- 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 aim of the non-interventional study is to prospectively collect and analyze data on the geriatric assessment of patients undergoing systemic 1st line therapy with trabectedin with focus on patients who have been assessed by the treating physician as being unsuited to receive standard chemotherapy with anthracyclines and / or ifosfamide.
Trabectedin will be used according to the local SmPC. Modification of the treatment schedule should follow the standard medical practice at the discretion of the treating physician and is not part of this Observational Plan.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | – | Other: No InterventionTrabectedin will be used according to the local SmPC. Modification of the treatment schedule should follow the standard medical practice at the discretion of the treating physician and is not part of this Observational Plan. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Elderly patients with advanced and/or metastatic STS (≥ 60 years including a maximum of 1/6 of "unsuited" patients younger than 60 years)
Key inclusion criteria (9 listed)
- Written informed consent
- Age of ≥ 60 years at study inclusion with a limited number of "unsuited" patients younger than 60 years
- Histologically proven advanced and/or metastatic STS, intermediate/high grade
- Presence of measurable disease according to RECIST 1.1. (optional, according to local clinical practice)
- Patients indicated for 1st line treatment with trabectedin according to local SmPC
Key exclusion criteria (13 listed)
- Histologically proven advanced and/or metastatic STS of the following tumor types:
- Embryonal rhabdomyosarcoma
- Chondrosarcoma (excluding extraskeletal myxoid chondrosarcoma)
- Osteosarcoma (excluding extraskeletal osteosarcoma)
- Ewing tumors/primitive neuroectodermal tumor
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No InterventionThis is a NIS. No intervention. | Other | Treatment Group |
Primary outcome
Overall survival
Time frame: 12 month after LPFV
Overall survival for each patient will be followed until the end of the study that is defined by 12 months after inclusion of the last patient.
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 4 Apr 2022.
- Individual participant dataSharing planned: No
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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.
Bernd Kasper, Prof. principal investigator
University of Heidelberg Mannheim University Medical Center Interdisciplinary Tumor Center, Sarcoma Unit
12 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Advanced Soft-tissue Sarcoma and Metastatic Soft-tissue Sarcoma, run by GWT-TUD GmbH at 12 sites in 3 countries.
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 9 inclusion and 13 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 4 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Germany, Austria, Switzerland. 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?
Overall survival (time frame: 12 month after LPFV). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Apr 2022.