Soft Tissue SarcomaPROTraSarcNCT06050434
Prospective Study to Evaluate Patient Reported Outcomes (PRO) During Rechallenge With Trabectedin in Sarcoma Patients
An observational study of Soft Tissue Sarcoma, run by Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest at 9 sites in Germany.
Trial summary
Chemotherapy with Trabectedin is an effective treatment for sarcoma patients in the second line setting or in first line for patients who are deemed unsuitable to receive anthracycline therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Soft Tissue Sarcoma
- How many people
- 7 participants
- Where
- 9 sitesGermany
- Study dates
- 31 Oct 2023to 30 Jul 2024
- How long will I take part?
- 3 Years
- 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
- Adult, Older adult
Study population: Adult GISAR participants with Trabectedin-pretreated soft tissue sarcomas and rechallenge with at least one cycle of Trabectedin in any line of therapy, with the interval between Trabectedin interruption and Trabectedin rechallenge being at least 3 months.
Who may be able to join
- Enrolled participant of the GISAR registry and their sub-studies
- Patient with histologically confirmed soft tissue sarcomas
- Pretreatment with Trabectedin, termination of this therapy regardless of reason
- Planned rechallenge or started rechallenge with Trabectedin in any line of therapy within 2 weeks before inclusion
- Interval between last Trabectedin treatment and Trabectedin rechallenge at least 3 months
Who cannot join
- Not able to understand all implications of study participation
- No written informed consent
- Age ≤ 18 years
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Germany9 sites
HELIOS KLinikum Bad Saarow
Bad Saarow
HELIOS Klinikum Berlin Buch
Berlin
Frankfurt Universitätsklinikum
Frankfurt am Main
Universitätsmedizin Göttingen
Göttingen
Universitätsmedizin Greifswald
Greifswald
Uniklinikum Leipzig
Leipzig
Universitätsmedizin Mainz
Mainz
Westfälische Wilhelms-Universität Münster
Münster
Universitätsklinikum Tübingen
Tübingen
About this study
Official title: PROTraSarc Prospective Study to Evaluate Patient Reported Outcomes (PRO) During Rechallenge With Trabectedin in Sarcoma Patients - A GISAR Sub-study
Chemotherapy with Trabectedin is an effective treatment for sarcoma patients in the second line setting or in first line for patients who are deemed unsuitable to receive anthracycline therapy. The prospective study will primarily investigate the PRO of Trabectedin rechallenge in patients with soft tissue sarcomas that had to discontinue initial Trabectedin treatment due to various reasons such as progression, side effects or surgery, as is commonly the case in real-life settings. Embedding this trial in the GISAR registry enables the evaluation of a large number of patients with long-term follow-up which allows multiple analyses regarding different questions that remain unanswered until today.
Read the detailed description
Chemotherapy with Trabectedin is an effective treatment for sarcoma patients in the second line setting or in first line for patients who are deemed unsuitable to receive anthracycline therapy. Several features differentiate its clinical performance from other chemotherapeutic agents, including durability of response and the absence of cumulative toxicity even upon re-exposition to treatment after interruption of therapy. In addition, the results of the T-Dis trial evaluating the impact of Trabectedin rechallenge demonstrated that it retains its activity when patients are rechallenged on progression after a treatment break.
Since sarcoma patient usually report a worse global quality of life (QoL) compared to the general population, one of the main goals of treating advanced-stage patients with Trabectedin, in addition to its efficacy, is to improve the QoL, represented by symptom control and other patient-related outcomes. However, little is known to date about the QoL during a rechallenge with Trabectedin, after patients had to discontinue Trabectedin treatment.
Patient-reported outcome (PRO) measures are standardized questionnaires that collect information on health outcomes directly from the patients, including symptoms, health-related QoL parameters and functional status. In general, there are two types of PROMs, disease-specific and general measures that can also be used for healthy populations. A growing number of articles supports the need for, as well as the benefit of, deriving information directly from patients. Thus, the application of PRO measures, initially developed for the use in research, has become more common nowadays and their application is included in supporting clinical decision making, comparing outcomes among health-care providers, stimulating quality improvement and evaluating practices and policies. Therefore, the collection of real-world data from patients subject to Trabectedin rechallenge would enable further estimations on the feasibility and efficacy of Trabectedin rechallenge.
The prospective PROTraSarc sub-study will primarily investigate the PRO of Trabectedin rechallenge in patients with soft tissue sarcomas that had to discontinue initial Trabectedin treatment due to various reasons such as progression, side effects or surgery, as is commonly the case in real-life settings. Embedding this trial in the GISAR registry enables the evaluation of a large number of patients with long-term follow-up which allows multiple analyses regarding different questions that remain unanswered until today.
- Conditions
- Soft Tissue Sarcoma
- Keywords
- Re-Challenge, Trabectedin, Sarcoma, registry, PRO
- Medical subject headings
- Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Trabectedin Rechallenge in Soft sarcoma patients | Adult GISAR participants with Trabectedin-pretreated soft tissue sarcomas and rechallenge with at least one cycle of Trabectedin in any line of therapy, with the interval between Trabectedin interruption and Trabectedin rechallenge being at least 3 months. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient reported outcome regarding symptoms and side effects during Trabectedin re-challenge in soft tissue sarcoma patients
PRO-CTCAE questionnaire
Measured: through study completion, an average of 2 years
Patient reported outcome regarding distress during Trabectedin re-challenge in soft tissue sarcoma patients
Distress-Thermometer
Measured: through study completion, an average of 2 years
Patient reported outcome regarding quality of life during Trabectedin re-challenge in soft tissue sarcoma patients
QLQ-C30 Questionnaire
Measured: through study completion, an average of 2 years
Patient reported outcome regarding cancer behaviour inventory
CBI-B Questionnaire
Measured: every nine to 18 weeks during Trabectedin re-challenge, every 3 Month in follow up
Patient reported outcome measuring anxiety and depression
PHQ-4 Questionnaire
Measured: through study completion, an average of 2 years
Patient reported outcome measuring self-efficacy for managing chronic disease
SES6G Questionnaire
Measured: through study completion, an average of 2 years
Secondary outcomes (3)
Analysis of correlation of PROs with clinical parameters
Evaluation of different PROs and analysis of correlation with clinical parameters, e.g. therapy response and side effects experienced during therapy
Measured: through study completion, an average of 2 years
Characterization of patients receiving Trabectedin rechallenge in real life setting
Characterization of patients receiving Trabectedin rechallenge in real life setting, e.g. demographics, previous therapies
Measured: through study completion, an average of 2 years
Characterization of Trabectedin rechallenge in real life conditions
Characterization of Trabectedin rechallenge in real life conditions, e.g. number of Trabectedin cycles applied, response to therapy, reason for end of Trabectedin rechallenge (e.g. disease progression, intolerable toxicity, death)
Measured: through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2023
- Study start31 Oct 2023
- Primary completion30 Jul 2024
- Study completion30 Jul 2024
Why it stopped: The study was terminated prematurely due to slow recruitment after inclusion of 7 patients (of initially planned 100 patients).
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 7 participants (actual)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
- Sponsor type
- University, hospital or other
- Collaborators
- PharmaMar
- Responsible party
- Sponsor
- Investigators
- Markus Schuler, PD Dr. med., Principal investigator, Onkologischer Schwerpunkt Oskar-Helene-Heim, Clinic and Polyclinic for Internal Medicine I, University Hospital Carl Gustav Carus, TU Dresden, Dresden, GermanyDaniel Pink, PD Dr. med., Principal investigator, Sarcoma Center Berlin-Brandenburg, Helios Hospital Bad Saarow, Department of Internal Medicine C, University Hospital Greifswald, GermanySalah-Eddin Al-Batran, Prof. Dr. med., Study director, Institut für Klinische Krebsforschung am Krankenhaus Nordwest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06050434
- Sponsor's protocol ID
- PROTraSarc
- Acronym
- PROTraSarc
- Status last verified
- Nov 2025
- First submitted
- 12 Jul 2023
- Last updated
- 1 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: will not be shared
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PROTraSarc Prospective Study to Evaluate Patient Reported Outcomes (PRO) During Rechallenge With Trabectedin in Sarcoma Patients - A GISAR Sub-study
- ClinicalTrials.gov ID
- NCT06050434
- Acronym / sponsor ID
- PROTraSarc / PROTraSarc
- Conditions
- Soft Tissue Sarcoma
- Keywords
- Re-Challenge, Trabectedin, Sarcoma, registry, PRO
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The study was terminated prematurely due to slow recruitment after inclusion of 7 patients (of initially planned 100 patients).
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus NordwestUniversity, hospital or other
- Collaborators
- PharmaMar
- Study start
- 31 Oct 2023 (actual)
- Primary completion
- 30 Jul 2024 (actual)
- Study completion
- 30 Jul 2024 (actual)
- First posted
- 22 Sep 2023 (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.
Chemotherapy with Trabectedin is an effective treatment for sarcoma patients in the second line setting or in first line for patients who are deemed unsuitable to receive anthracycline therapy. The prospective study will primarily investigate the PRO of Trabectedin rechallenge in patients with soft tissue sarcomas that had to discontinue initial Trabectedin treatment due to various reasons such as progression, side effects or surgery, as is commonly the case in real-life settings. Embedding this trial in the GISAR registry enables the evaluation of a large number of patients with long-term follow-up which allows multiple analyses regarding different questions that remain unanswered until today.
Detailed description
Chemotherapy with Trabectedin is an effective treatment for sarcoma patients in the second line setting or in first line for patients who are deemed unsuitable to receive anthracycline therapy. Several features differentiate its clinical performance from other chemotherapeutic agents, including durability of response and the absence of cumulative toxicity even upon re-exposition to treatment after interruption of therapy. In addition, the results of the T-Dis trial evaluating the impact of Trabectedin rechallenge demonstrated that it retains its activity when patients are rechallenged on progression after a treatment break.
Since sarcoma patient usually report a worse global quality of life (QoL) compared to the general population, one of the main goals of treating advanced-stage patients with Trabectedin, in addition to its efficacy, is to improve the QoL, represented by symptom control and other patient-related outcomes. However, little is known to date about the QoL during a rechallenge with Trabectedin, after patients had to discontinue Trabectedin treatment.
Patient-reported outcome (PRO) measures are standardized questionnaires that collect information on health outcomes directly from the patients, including symptoms, health-related QoL parameters and functional status. In general, there are two types of PROMs, disease-specific and general measures that can also be used for healthy populations. A growing number of articles supports the need for, as well as the benefit of, deriving information directly from patients. Thus, the application of PRO measures, initially developed for the use in research, has become more common nowadays and their application is included in supporting clinical decision making, comparing outcomes among health-care providers, stimulating quality improvement and evaluating practices and policies. Therefore, the collection of real-world data from patients subject to Trabectedin rechallenge would enable further estimations on the feasibility and efficacy of Trabectedin rechallenge.
The prospective PROTraSarc sub-study will primarily investigate the PRO of Trabectedin rechallenge in patients with soft tissue sarcomas that had to discontinue initial Trabectedin treatment due to various reasons such as progression, side effects or surgery, as is commonly the case in real-life settings. Embedding this trial in the GISAR registry enables the evaluation of a large number of patients with long-term follow-up which allows multiple analyses regarding different questions that remain unanswered until today.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Trabectedin Rechallenge in Soft sarcoma patients | – | –Adult GISAR participants with Trabectedin-pretreated soft tissue sarcomas and rechallenge with at least one cycle of Trabectedin in any line of therapy, with the interval between Trabectedin interruption and Trabectedin rechallenge being at least 3 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adult GISAR participants with Trabectedin-pretreated soft tissue sarcomas and rechallenge with at least one cycle of Trabectedin in any line of therapy, with the interval between Trabectedin interruption and Trabectedin rechallenge being at least 3 months.
Key inclusion criteria (5 listed)
- Enrolled participant of the GISAR registry and their sub-studies
- Patient with histologically confirmed soft tissue sarcomas
- Pretreatment with Trabectedin, termination of this therapy regardless of reason
- Planned rechallenge or started rechallenge with Trabectedin in any line of therapy within 2 weeks before inclusion
- Interval between last Trabectedin treatment and Trabectedin rechallenge at least 3 months
Key exclusion criteria (3 listed)
- Not able to understand all implications of study participation
- No written informed consent
- Age ≤ 18 years
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
Patient reported outcome regarding symptoms and side effects during Trabectedin re-challenge in soft tissue sarcoma patients
Time frame: through study completion, an average of 2 years
PRO-CTCAE questionnaire
Patient reported outcome regarding distress during Trabectedin re-challenge in soft tissue sarcoma patients
Time frame: through study completion, an average of 2 years
Distress-Thermometer
Patient reported outcome regarding quality of life during Trabectedin re-challenge in soft tissue sarcoma patients
Time frame: through study completion, an average of 2 years
QLQ-C30 Questionnaire
Patient reported outcome regarding cancer behaviour inventory
Time frame: every nine to 18 weeks during Trabectedin re-challenge, every 3 Month in follow up
CBI-B Questionnaire
Patient reported outcome measuring anxiety and depression
Time frame: through study completion, an average of 2 years
PHQ-4 Questionnaire
Patient reported outcome measuring self-efficacy for managing chronic disease
Time frame: through study completion, an average of 2 years
SES6G Questionnaire
3 secondary outcomes
Analysis of correlation of PROs with clinical parameters
Time frame: through study completion, an average of 2 years
Characterization of patients receiving Trabectedin rechallenge in real life setting
Time frame: through study completion, an average of 2 years
Characterization of Trabectedin rechallenge in real life conditions
Time frame: through study completion, an average of 2 years
Results and safety
The study was stopped early (reason given: The study was terminated prematurely due to slow recruitment after inclusion of 7 patients (of initially planned 100 patients).). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2025.
- Individual participant dataSharing planned: No. will not be shared
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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.
Markus Schuler, PD Dr. med. principal investigator
Onkologischer Schwerpunkt Oskar-Helene-Heim, Clinic and Polyclinic for Internal Medicine I, University Hospital Carl Gustav Carus, TU Dresden, Dresden, Germany
Daniel Pink, PD Dr. med. principal investigator
Sarcoma Center Berlin-Brandenburg, Helios Hospital Bad Saarow, Department of Internal Medicine C, University Hospital Greifswald, Germany
Salah-Eddin Al-Batran, Prof. Dr. med. study director
Institut für Klinische Krebsforschung am Krankenhaus Nordwest
9 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 Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest at 9 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 5 inclusion and 3 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: stopped early, as of the sponsor's last update on 1 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 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 was stopped early (reason given: The study was terminated prematurely due to slow recruitment after inclusion of 7 patients (of initially planned 100 patients).). Results are not available in the source record.
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?
Patient reported outcome regarding symptoms and side effects during Trabectedin re-challenge in soft tissue sarcoma patients (time frame: through study completion, an average of 2 years). The study lists 6 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 1 Dec 2025.