Retrospective Analysis Of Progression Free Survival And Overall Survival In A National Cohort Of Patients With Metastatic Renal Cell Carcinoma Treated In Denmark From 2006-2010. DARENCA Study 2.
August 15, 2014 updated by: Pfizer
Non-interventional study. Data obtained by patient chart reviews.
Retrospective analysis of progression free survival, time to treatment failure and overall survival in a national cohort of patients with metastatic renal cell carcinoma treated in Denmark from 2006-2010 Safety, prognostic factors, predictive factors and co-morbidity assessed by Charlson Comorbidity Index.
The following drugs will be evaluated: Sunitinib, Sorafenib, Temsirolimus, Everolimus, Aldesleukin, Interferon-alfa-2b.
Study Overview
Detailed Description
No sampling.
All eligible patients will be included.
Study Type
Observational
Enrollment (Actual)
1073
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Herlev, Denmark, 2730
- University of Copenhagen Herlev Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
All Danish patients diagnosed with metastatic renal cell carcinoma referred to the involved centers.
Description
Inclusion Criteria:
Metastatic renal cell carcinoma
Exclusion Criteria:
None
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Non-Interventional Study
Outcomes Research Study
|
Non-interventional (retrospective chart reviews)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Overall survival from initiation of first systemic anticancer therapy
Time Frame: 8 months
|
8 months
|
|
Progression free survival from initiation of each systemic anticancer therapy separately
Time Frame: 8 months
|
8 months
|
|
Time to treatment failure from initiation of each systemic anticancer therapy separately
Time Frame: 8 months
|
8 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Prognostic factors at baseline associated with efficacy (PFS) of each systemic anticancer therapy and overall survival
Time Frame: 8 months
|
8 months
|
|
Serious Adverse Events: Defined as AEs leading to dose adjustment, treatment interruption/ cessation or death.
Time Frame: 8 months
|
8 months
|
|
Predictive factors
Time Frame: 8 months
|
8 months
|
|
Co-morbidity assessed by Charlson Comorbidity Index
Time Frame: 8 months
|
8 months
|
|
Combined PFS and OS on sequential treatment
Time Frame: 8 months
|
8 months
|
|
Assessment of first line immunotherapy´s effect on second line targeted therapy
Time Frame: 8 months
|
8 months
|
|
Assessment of prognostic factors and overall survival for patients not receiving systemic therapy
Time Frame: 8 months
|
8 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2011
Primary Completion (Actual)
April 1, 2012
Study Completion (Actual)
April 1, 2012
Study Registration Dates
First Submitted
April 15, 2011
First Submitted That Met QC Criteria
April 20, 2011
First Posted (Estimate)
April 21, 2011
Study Record Updates
Last Update Posted (Estimate)
August 18, 2014
Last Update Submitted That Met QC Criteria
August 15, 2014
Last Verified
August 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- A6181203
- DARENCA STUDY 2
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