Soft Tissue SarcomaYonSarNCT02367924
Efficacy and Safety of Trabectedin (Yondelis®) in Patients With Advanced Soft Tissue Sarcoma
An observational study of Soft Tissue Sarcoma, run by PharmaMar, Spain at 19 sites in Germany.
Trial summary
Efficacy and safety of trabectedin in real-life practice, routinely used for the management of advanced sarcoma after failure of anthracyclines and ifosfamide or patients unsuited to receive these drugs in Germany. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Soft Tissue Sarcoma
- What is being tested?
- trabectedin
- How many people
- 130 participants
- Where
- 19 sitesGermany
- Study dates
- 16 Jul 2015to 31 Dec 2020
- 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: 100 patients (≥ 18 years) with advanced sarcoma after failure of anthracyclines and ifosfamide or patients unsuited to receive these drugs
Who may be able to join
- Patients must comply with all of the following criteria in order to be enrolled into the study:
- Histologically diagnosed advanced STS
- Female or male aged 18 years or above
- Signed written informed consent
- Suitable to undergo treatment with trabectedin according to SmPC
- Progress after therapy with anthracyclines and ifosfamide has failed, or if patients are unsuited to receive these agents
Who cannot join
- Patients presenting contraindications for the use of trabectedin as defined in the SmPC will be excluded from participating in the study.
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
Germany19 sites
Universitätsklinikum Augsburg A.d.ö.R - II. Medizinische Klinik
Augsburg, Bavaria, 86156
HELIOS Klinikum Bad Saarow
Bad Saarow, Brandenburg, 15526
Charité - Universitätsmedizin Berlin
Berlin, 13353
Praxis für Innere Medizin, Hämatologie u. Onkologie
Bremen, 28209
Onkologisches Zentrum Donauwörth
Donauwörth, Bavaria, 86609
Universitätsklinikum Hamburg-Eppendorf
Hamburg, 20246
Onko-Kolleg GmbH & Co. KG - Überörtliche Gemeinschaftspraxis Dres. Verpoort, Wierecky, Zeller
Hamburg, 20259
Medizinische Hochschule Hannover - Klinik für Hämatologie, Hämostaseologie, Onkologie und Stammzelltransplantation
Hanover, Lower Saxony, 30625
Universitätsklinikum Heidelberg
Heidelberg, Baden-Wurttemberg, 69120
Universitätsklinikum Schleswig-Holstein
Lübeck, Schleswig-Holstein, 23538
Universitätsklinikum Magdeburg A.ö.R.
Magdeburg, Saxony-Anhalt, 39120
LMU - Klinikum der Universität München - Medizinische Klinik und Poliklinik III/Hämatologie und Onkologie
München, Bavaria, 81377
Klinikum Nürnberg Nord - Medizinische Klinik 5, Schwerpunkt Onkologie/Hämatologie
Nuremberg, Bavaria, 90419
Klinikum der Landeshauptstadt Stuttgart gKAöR - Klinik für Onkologie
Stuttgart, Baden-Wurttemberg, 70174
MVZ Marien-Hospital-Wesel GmbH
Wesel, North Rhine-Westphalia, 46483
Gemeinschaftspraxis Dr. Reichert, Dr. Janssen
Westerstede, Lower Saxony, 26655
Lahn-Dill-Kliniken GmbH
Wetzlar, Hesse, 35578
Praxis Dr. Rodemer
Wilhelmshaven, Lower Saxony, 26389
Universitätsklinikum Würzburg - Medizinische Klinik und Poliklinik II
Würzburg, Bavaria, 97080
About this study
Official title: Non-interventional Study to Investigate Efficacy and Safety of Trabectedin (Yondelis®) in Patients With Advanced Soft Tissue Sarcoma
Efficacy and safety of trabectedin in real-life practice, routinely used for the management of advanced sarcoma after failure of anthracyclines and ifosfamide or patients unsuited to receive these drugs in Germany.
Trabectedin is indicated for the treatment of patients with advanced soft tissue sarcoma, after failure of anthracyclines and ifosfamide, or who are unsuited to receive these agents. Efficacy data are based mainly on liposarcoma and leiomyosarcoma patients.
Read the detailed description
This is a non-interventional, observational and prospective study to evaluate efficacy and safety of trabectedin in routine practice. Patients are assigned to a therapeutic strategy within current practice, not according to a trial protocol. The prescription of the medicine is separated from the decision to include the patient in the study. Diagnostic or monitoring procedures are only those ordinarily applied to the therapeutic strategy.
There are no dose regimens or medical procedures defined within this study plan. Every medical decision and course of treatment with trabectedin will reflect exclusively the decision of the Investigator in a routine clinical situation according to SmPC. The concept of this non-interventional study and its documentation procedure will not affect in any way the routine treatment situation.
- Conditions
- Soft Tissue Sarcoma
- Being tested
- trabectedin
- Medical subject headings
- Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
trabectedinDrug
Also called Yondelis
The administration of chemotherapy regimen with trabectedin (according to Summary of Product Characteristics (SmPC)) will be determined by the Investigator's discretion depending on the patients' conditions and previous chemotherapy.
| Study group | Role | What they receive |
|---|---|---|
| Yondelis | The administration of chemotherapy regimen with trabectedin (according to Summary of Product Characteristics (SmPC)) will be determined by the Investigator's discretion depending on the patients' conditions and previous chemotherapy. Receives: Drug: trabectedin |
What is being measured
The primary outcome is the main question the study is designed to answer.
3 months progression free survival (PFS) rate
Number of patients without PD or death 3 months after start of therapy
Measured: 3 months after start of therapy
6 months progression free survival (PFS) rate
Number of patients without PD or death 6 months after start of therapy
Measured: 6 months after start of therapy
Secondary outcomes (7)
Tumor control rate
Best response (CR+PR+Disease stabilization) according to institutional standards
Measured: in average 6 months
3 and 6 months overall survival (OS) rate
Number of patients alive after 3 months and 6 months
Measured: 3 and 6 months after start of therapy
Progression free survival (PFS)
Time from start of therapy to the date of documented PD or death (death of any cause)
Measured: in average 6 months
Type of treatment used
dose reductions and postponement of cycles
Measured: 2 years
Treatment duration
Number of cycles
Measured: from first cycle up to a maximum of 17 cycles, each cycle is 21 days (= 1 year)
Reason for discontinuation of trabectedin treatment
Analysis of documented reasons
Measured: from first cycle up to a maximum of 17 cycles, each cycle is 21 days (= 1 year)
General description of grade 3/4 adverse events
Adverse events of grade 3/4 according to NCI CTC V4
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2015 (estimated)
- Study start16 Jul 2015
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Other
- Time perspective
- Prospective
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- PharmaMar, Spain
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Viktor Grünwald, Dr., Principal investigator, Hannover Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02367924
- Sponsor's protocol ID
- ET-D-023-13
- Acronym
- YonSar
- Status last verified
- Jun 2023
- First submitted
- 4 Feb 2015
- Last updated
- 22 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-interventional Study to Investigate Efficacy and Safety of Trabectedin (Yondelis®) in Patients With Advanced Soft Tissue Sarcoma
- ClinicalTrials.gov ID
- NCT02367924
- Acronym / sponsor ID
- YonSar / ET-D-023-13
- Conditions
- Soft Tissue Sarcoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- PharmaMar, SpainIndustry (pharma, biotech, devices)
- Study start
- 16 Jul 2015 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 20 Feb 2015 (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.
Efficacy and safety of trabectedin in real-life practice, routinely used for the management of advanced sarcoma after failure of anthracyclines and ifosfamide or patients unsuited to receive these drugs in Germany.
Trabectedin is indicated for the treatment of patients with advanced soft tissue sarcoma, after failure of anthracyclines and ifosfamide, or who are unsuited to receive these agents. Efficacy data are based mainly on liposarcoma and leiomyosarcoma patients.
Detailed description
This is a non-interventional, observational and prospective study to evaluate efficacy and safety of trabectedin in routine practice. Patients are assigned to a therapeutic strategy within current practice, not according to a trial protocol. The prescription of the medicine is separated from the decision to include the patient in the study. Diagnostic or monitoring procedures are only those ordinarily applied to the therapeutic strategy.
There are no dose regimens or medical procedures defined within this study plan. Every medical decision and course of treatment with trabectedin will reflect exclusively the decision of the Investigator in a routine clinical situation according to SmPC. The concept of this non-interventional study and its documentation procedure will not affect in any way the routine treatment situation.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Yondelis | – | Drug: trabectedinThe administration of chemotherapy regimen with trabectedin (according to Summary of Product Characteristics (SmPC)) will be determined by the Investigator's discretion depending on the patients' conditions and previous chemotherapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 100 patients (≥ 18 years) with advanced sarcoma after failure of anthracyclines and ifosfamide or patients unsuited to receive these drugs
Key inclusion criteria (6 listed)
- Patients must comply with all of the following criteria in order to be enrolled into the study:
Key exclusion criteria (1 listed)
- Patients presenting contraindications for the use of trabectedin as defined in the SmPC will be excluded from participating in the study.
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 |
|---|---|---|
| trabectedinAlso: YondelisThe administration of chemotherapy regimen with trabectedin (according to Summary of Product Characteristics (SmPC)) will be determined by the Investigator's discretion depending on the patients' conditions and previous chemotherapy. | Drug | Yondelis |
Primary outcome
3 months progression free survival (PFS) rate
Time frame: 3 months after start of therapy
Number of patients without PD or death 3 months after start of therapy
6 months progression free survival (PFS) rate
Time frame: 6 months after start of therapy
Number of patients without PD or death 6 months after start of therapy
7 secondary outcomes
Tumor control rate
Time frame: in average 6 months
3 and 6 months overall survival (OS) rate
Time frame: 3 and 6 months after start of therapy
Progression free survival (PFS)
Time frame: in average 6 months
Type of treatment used
Time frame: 2 years
Treatment duration
Time frame: from first cycle up to a maximum of 17 cycles, each cycle is 21 days (= 1 year)
Reason for discontinuation of trabectedin treatment
Time frame: from first cycle up to a maximum of 17 cycles, each cycle is 21 days (= 1 year)
General description of grade 3/4 adverse events
Time frame: 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 22 Jun 2023.
- Individual participant dataSharing planned: Undecided
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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.
Viktor Grünwald, Dr. principal investigator
Hannover Medical School
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Soft Tissue Sarcoma, run by PharmaMar, Spain at 19 sites 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 6 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 22 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites 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?
3 months progression free survival (PFS) rate (time frame: 3 months after start of therapy). 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?
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 22 Jun 2023.