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

PharmaMar, Spain130 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

130

Conditions

Soft Tissue Sarcoma

Interventions

trabectedinDRUG

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (19)

Universitätsklinikum Heidelberg

Heidelberg, Baden-Wurttemberg, Germany

Outcomes

Primary Outcomes

3 months progression free survival (PFS) rate

Number of patients without PD or death 3 months after start of therapy

Time frame: 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

Time frame: 6 months after start of therapy

Secondary Outcomes

Tumor control rate

Best response (CR+PR+Disease stabilization) according to institutional standards

Time frame: in average 6 months

3 and 6 months overall survival (OS) rate

Number of patients alive after 3 months and 6 months

Time frame: 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)

Time frame: in average 6 months

Type of treatment used

dose reductions and postponement of cycles

Time frame: 2 years

Treatment duration

Number of cycles

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

Analysis of documented reasons

Time frame: from first cycle up to a maximum of 17 cycles, each cycle is 21 days (= 1 year)

Data from ClinicalTrials.gov

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