Efficacy and Safety of Trabectedin (Yondelis®) in Patients With Advanced Soft Tissue Sarcoma

Study Overview
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Brief Summary
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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
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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.

Official Title
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Non-interventional Study to Investigate Efficacy and Safety of Trabectedin (Yondelis®) in Patients With Advanced Soft Tissue Sarcoma

Conditions
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Soft Tissue Sarcoma

Intervention / Treatment
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* Drug: trabectedin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Patients presenting contraindications for the use of trabectedin as defined in the SmPC will be excluded from participating in the study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Yondelis<br>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. | Drug: trabectedin<br>* 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.<br>* Other names: Yondelis;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 3 months progression free survival (PFS) rate | Number of patients without PD or death 3 months after start of therapy | 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 | 6 months after start of therapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tumor control rate | Best response (CR+PR+Disease stabilization) according to institutional standards | in average 6 months | 
| 3 and 6 months overall survival (OS) rate | Number of patients alive after 3 months and 6 months | 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) | in average 6 months | 
| Type of treatment used | dose reductions and postponement of cycles | 2 years | 
| Treatment duration | Number of cycles | 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 | 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 | 2 years |