Last updated: 02/04/2020 14:40:11
Quality-adjusted Time Without Symptoms or Toxicity (Q-TWiST) Analysis of COMPARZ Data
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
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
Observational study model:
Other
Primary completion date:
2014-05-02
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)
No location data available.
Study documents
Clinical study report
Available language(s): English
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
Finalized
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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