Last updated: 02/04/2020 14:40:11

Quality-adjusted Time Without Symptoms or Toxicity (Q-TWiST) Analysis of COMPARZ Data

GSK study ID
201295
See study documents
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: Quality-adjusted Time Without Symptoms or Toxicity (Q-TWiST) Analysis of COMPARZ Data
Trial description: In a phase 3, randomized, open-label trial (NCT00720941 - COMPARZ), Pazopanib demonstrated non-inferiority for progression-free survival vs sunitinib in (metastatic Renal Cell Carcinoma) mRCC patients with no prior therapy (NEJM 2013; 369: 722). In this post-hoc analysis overall treatment differences will be evaluated using the quality-adjusted time without symptoms of progression or toxicity of treatment (Q-TWiST).
Each patient’s overall survival (OS) will be partitioned into 3 health states: grade 3 or 4 toxicity (TOX), time without symptoms of progression or toxicity (TWiST), and time after progression or relapse (REL). The time spent in each state will be then weighted by a health-state utility associated with that state and summed to calculate the Q-TWiST. A threshold utility analysis will beused, applying utilities across the range of 0 (similar to death) to 1 (perfect health).
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Quality-adjusted time without symptoms or toxicity

Timeframe: 6 Months

Secondary outcomes:
Not applicable
Interventions:
  • Drug: Pazopanib
  • Drug: Sunitinib
    • Enrollment:
    0
    Primary completion date:
    2014-05-02
    Observational study model:
    Other
    Time perspective:
    Other
    Clinical publications:
    Not applicable
    Medical condition
    Carcinoma, Renal Cell
    Product
    pazopanib, sunitinib
    Collaborators
    Northwestern University
    Study date(s)
    January 2014 to February 2014
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    Not applicable
    Accepts healthy volunteers
    none
    • This is a Post-hoc analysis of the COMPARZ trial
    • This is a Post-hoc analysis of the COMPARZ trial
    Inclusion and exclusion criteria
    Inclusion criteria:
    • This is a Post-hoc analysis of the COMPARZ trial
    Exclusion criteria:
    • This is a Post-hoc analysis of the COMPARZ trial

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    Clinical study report
    Available language(s): English
    Download document(s)
    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
    Study complete
    Actual primary completion date
    2014-05-02
    Actual study completion date
    2014-05-02

    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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