Advanced Soft Tissue SarcomabeYOND-STSNCT02618122
A Multicenter, Prospective, oBservational Study to assEss the Clinical activitY and Impact on symptOm Burden and patieNts' HRQoL of Treatment With trabecteDin in aSTS in a Real World Setting in Greece
An observational study of Advanced Soft Tissue Sarcoma, run by Genesis Pharma S.A. at 1 site in Greece.
Trial summary
This non-interventional study aims primarily at assessing the clinical effectiveness and the impact of the therapy on cancer-related symptoms and patients' HRQoL. In addition, it represents an attempt towards gaining experience on the routine use of trabectedin in daily clinical practice in a representative sample of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Soft Tissue Sarcoma
- How many people
- 63 participants
- Where
- 1 siteGreece
- Study dates
- Dec 2015to 6 Aug 2019
- 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: Adult patients with a histologically confirmed diagnosis of advanced (locally advanced or metastatic) soft tissue sarcoma who have failed treatment with anthracyclines and ifosfamide or who are unsuited to receive these drugs
Who may be able to join
- Patients eligible for inclusion in this study have to meet all of the following criteria:
- Adult outpatients (18 years and older) of either gender;
- Patients with a histologically confirmed diagnosis of advanced (locally advanced or metastatic) soft tissue sarcoma who have failed treatment with anthracyclines and ifosfamide or who are unsuited to receive these drugs;
- Patients for whom the decision to prescribe therapy with trabectedin (Yondelis®) according to the locally approved product's summary of product characteristics (SmPC) has already been taken prior to their enrolment in the study and is clearly separated from the physician's decision to include the patient in the current study;
- Patients must be able and willing to provide written informed consent and to comply with the requirements of this study protocol;
- Patients must have signed an informed consent document;
- Patients must be able to read, understand and complete the study specific questionnaires.
Who cannot join
- A patient who meets any of the following criteria will be excluded from participation in this study:
- Patients who have received more than one cycle of trabectedin at the time of enrolment into the study;
- Patients that meet any of the contraindications to the administration of the study drug according to the approved SmPC;
- Patients who currently receive treatment with any investigational drug/device/intervention or have received any investigational product within 1 month or 5 half-lives of the investigational agent (whichever is longer) before the commencement of therapy with trabectedin.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter, Prospective, oBservational Study to assEss the Clinical activitY and the Impact on symptOm Burden and patieNts' HRQoL of Treatment With trabecteDin in Advanced Soft Tissue Sarcomas in a Real World Setting in Greece. The 'beYOND-STS' Study
This non-interventional study aims primarily at assessing the clinical effectiveness and the impact of the therapy on cancer-related symptoms and patients' HRQoL. In addition, it represents an attempt towards gaining experience on the routine use of trabectedin in daily clinical practice in a representative sample of Greek subjects with aSTS.
- Conditions
- Advanced Soft Tissue Sarcoma
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of patients that are alive and progression-free (as per the RECIST v1.1 criteria) 6 months after treatment commencement.
The proportion of patients that are alive and progression-free (as per the RECIST v1.1 criteria) 6 months after treatment commencement
Measured: 6 months post-treatment onset
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2015 (estimated)
- Study startDec 2015
- Primary completion30 Jun 2019
- Study completion6 Aug 2019
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genesis Pharma S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kiki Karvounis, Study director, GenesisPharma Medical Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02618122
- Sponsor's protocol ID
- NIS-GEN-TRA-001
- Acronym
- beYOND-STS
- Status last verified
- Nov 2020
- First submitted
- 25 Nov 2015
- Last updated
- 30 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Prospective, oBservational Study to assEss the Clinical activitY and the Impact on symptOm Burden and patieNts' HRQoL of Treatment With trabecteDin in Advanced Soft Tissue Sarcomas in a Real World Setting in Greece. The 'beYOND-STS' Study
- ClinicalTrials.gov ID
- NCT02618122
- Acronym / sponsor ID
- beYOND-STS / NIS-GEN-TRA-001
- Conditions
- Advanced Soft Tissue Sarcoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Genesis Pharma S.A.Industry (pharma, biotech, devices)
- Study start
- Dec 2015 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 6 Aug 2019 (actual)
- First posted
- 1 Dec 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.
This non-interventional study aims primarily at assessing the clinical effectiveness and the impact of the therapy on cancer-related symptoms and patients' HRQoL. In addition, it represents an attempt towards gaining experience on the routine use of trabectedin in daily clinical practice in a representative sample of Greek subjects with aSTS.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with a histologically confirmed diagnosis of advanced (locally advanced or metastatic) soft tissue sarcoma who have failed treatment with anthracyclines and ifosfamide or who are unsuited to receive these drugs
Key inclusion criteria (7 listed)
- Adult outpatients (18 years and older) of either gender;
- Patients with a histologically confirmed diagnosis of advanced (locally advanced or metastatic) soft tissue sarcoma who have failed treatment with anthracyclines and ifosfamide or who are unsuited to receive these drugs;
- Patients for whom the decision to prescribe therapy with trabectedin (Yondelis®) according to the locally approved product's summary of product characteristics (SmPC) has already been taken prior to their enrolment in the study and is clearly separated from the physician's decision to include the patient in the current study;
- Patients must be able and willing to provide written informed consent and to comply with the requirements of this study protocol;
- Patients must have signed an informed consent document;
Key exclusion criteria (4 listed)
- A patient who meets any of the following criteria will be excluded from participation in this study:
- Patients who have received more than one cycle of trabectedin at the time of enrolment into the study;
- Patients that meet any of the contraindications to the administration of the study drug according to the approved SmPC;
- Patients who currently receive treatment with any investigational drug/device/intervention or have received any investigational product within 1 month or 5 half-lives of the investigational agent (whichever is longer) before the commencement of therapy with trabectedin.
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
The proportion of patients that are alive and progression-free (as per the RECIST v1.1 criteria) 6 months after treatment commencement.
Time frame: 6 months post-treatment onset
The proportion of patients that are alive and progression-free (as per the RECIST v1.1 criteria) 6 months after treatment commencement
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 30 Nov 2020.
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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.
Kiki Karvounis study director
GenesisPharma Medical Department
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 Advanced Soft Tissue Sarcoma, run by Genesis Pharma S.A. at 1 site in Greece.
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 7 inclusion and 4 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 30 Nov 2020. 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 Greece. 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?
The proportion of patients that are alive and progression-free (as per the RECIST v1.1 criteria) 6 months after treatment commencement. (time frame: 6 months post-treatment onset). 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 30 Nov 2020; AzTrials last refreshed its copy on 31 Oct 2026.