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

Pharma Mar

Status: Completed

Conditions: Soft Tissue Sarcoma

Treatments: Drug: trabectedin

Study type: Observational

Funder types: Industry

Identifiers

NCT02367924

ET-D-023-13

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 130 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

130 participants in 1 patient group

Yondelis

Description:

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.

Treatment:

Drug: trabectedin