Clinical trial · Observational
Prospective Study to Evaluate Patient Reported Outcomes (PRO) During Rechallenge With Trabectedin in Sarcoma Patients
PROTraSarc Prospective Study to Evaluate Patient Reported Outcomes (PRO) During Rechallenge With Trabectedin in Sarcoma Patients - A GISAR Sub-study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The study was terminated prematurely due to slow recruitment after inclusion of 7 patients (of initially planned 100 patients).
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Soft Tissue Sarcoma | Soft Tissue Sarcoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- Trabectedin Rechallenge in Soft sarcoma patients
- description
- 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.
Primary outcomes (6)
- measure
- Patient reported outcome regarding symptoms and side effects during Trabectedin re-challenge in soft tissue sarcoma patients
- timeFrame
- through study completion, an average of 2 years
- description
- PRO-CTCAE questionnaire
- measure
- Patient reported outcome regarding distress during Trabectedin re-challenge in soft tissue sarcoma patients
- timeFrame
- through study completion, an average of 2 years
- description
- Distress-Thermometer
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * Not able to understand all implications of study participation * No written informed consent * Age ≤ 18 years
References
Publications (0)
Data not yet available