Last updated: 11/07/2018 11:18:23

Drug Treatment Patterns and Survival Among Patients with Metastatic or Recurrent Soft Tissue Sarcoma (m/rSTS) Refractory to at Least One Prior Therapy

GSK study ID
117006
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Drug Treatment Patterns and Survival Among Patients with Metastatic or Recurrent Soft Tissue Sarcoma (m/rSTS) Refractory to at Least One Prior Therapy
Trial description: Limited clinical data are available about the care of patients with metastatic/recurrent soft tissue sarcoma (m/rSTS) and real-world practice patterns. This study evaluates drug treatment patterns and outcomes in m/rSTS subjects following failure of prior chemotherapy.
The primary purpose of this study is to evaluate drug treatment patterns in m/rSTS subjects following failure of prior chemotherapy, based on data from a referral academic cancer center in the United States.
Data from medical records consented for research use will be retrospectively reviewed at Dana-Farber Cancer Institute for subjects with m/rSTS who were aged 18 years or older, commenced second-line systemic therapy between 1 January 2000 and 2 April 2011, had confirmed disease progression on or after first-line therapy and had at least 3 months of observation.
The study design is a retrospective, observational chart review.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Treatment Patterns

Timeframe: from diagnosis to death or end of chart record

Secondary outcomes:

Progression-free survival

Timeframe: from diagnosis to death or end of chart record

Overall survival

Timeframe: from diagnosis to death or end of chart record

Interventions:
  • Drug: Angiogenesis inhibitors
  • Drug: Trabectedin
  • Drug: Alkylating agents
  • Drug: Gemcitabine-based agents
  • Enrollment:
    99
    Primary completion date:
    Not applicable
    Observational study model:
    Cohort
    Time perspective:
    Retrospective
    Clinical publications:
    Wagner M, Amodu L, Duh M, et al.A retrospective chart review of drug treatment patterns and clinical outcomes among patients with metastatic or recurrent soft tissue sarcoma refractory to one or more prior chemotherapy treatments.BMC Cancer.2015;15(175)
    Medical condition
    Sarcoma, Soft tissue
    Product
    pazopanib
    Collaborators
    Not applicable
    Study date(s)
    June 2011 to June 2012
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    18+ years
    Accepts healthy volunteers
    none
    • A diagnosis of m/rSTS
    • Age 18 years or older
    • Treatment with pazopanib

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    Scientific result summary
    Available language(s): English

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    Not applicable
    Actual study completion date
    2012-04-06

    Plain language summaries

    Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

    Additional information about the trial

    Not applicable
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