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
See study documents
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
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
Observational study model:
Cohort
Primary completion date:
Not applicable
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
Inclusion and exclusion criteria
Inclusion criteria:
  • A diagnosis of m/rSTS
  • Age 18 years or older
  • Commenced second-line systematic therapy between 1 January 2000 and 2 April 2011
  • Confirmed disease progression on or after first-line therapy
  • At least 3 months of observed data following commencement of second-line therapy
Exclusion criteria:
  • Treatment with pazopanib

Trial location(s)

No location data available.

Study documents

Scientific result summary
Available language(s): English
Download document(s)

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

Results overview

Refer to study documents

Recruitment status
Finalized
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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