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Completed

NCT Number: NCT02367924

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

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.

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Key information

Conditions

Soft Tissue Sarcoma Neoplasms Neoplasms by Histologic Type Neoplasms, Connective and Soft Tissue Sarcoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Universitätsklinikum Heidelberg, Heidelberg, Baden-Wurttemberg, Germany

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Trabectedin

Drug

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.

Other names: Yondelis

Primary outcomes

  1. 3 months progression free survival (PFS) rate

    Time frame: 3 months after start of therapy

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

  2. 6 months progression free survival (PFS) rate

    Time frame: 6 months after start of therapy

    Number of patients without PD or death 6 months after start of therapy

Secondary outcomes

  1. Tumor control rate

    Time frame: in average 6 months

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

  2. 3 and 6 months overall survival (OS) rate

    Time frame: 3 and 6 months after start of therapy

    Number of patients alive after 3 months and 6 months

  3. Progression free survival (PFS)

    Time frame: in average 6 months

    Time from start of therapy to the date of documented PD or death (death of any cause)

  4. Type of treatment used

    Time frame: 2 years

    dose reductions and postponement of cycles

  5. Treatment duration

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

    Number of cycles

  6. Reason for discontinuation of trabectedin treatment

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

    Analysis of documented reasons

  7. General description of grade 3/4 adverse events

    Time frame: 2 years

    Adverse events of grade 3/4 according to NCI CTC V4

Sponsors and collaborators

Lead sponsor

PharmaMar, Spain

Industry

Registry information

Official study title

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

Acronym: YonSar

Important dates

Study start
2015
Primary completion
2020
Study completion
2020
First posted
Feb 20, 2015
Registry last updated
Jun 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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