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.
2 other identifiers
observational
1,073
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2011
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2011
CompletedFirst Submitted
Initial submission to the registry
April 15, 2011
CompletedFirst Posted
Study publicly available on registry
April 21, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2012
CompletedAugust 18, 2014
August 1, 2014
1 year
April 15, 2011
August 15, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Overall survival from initiation of first systemic anticancer therapy
8 months
Progression free survival from initiation of each systemic anticancer therapy separately
8 months
Time to treatment failure from initiation of each systemic anticancer therapy separately
8 months
Secondary Outcomes (7)
Prognostic factors at baseline associated with efficacy (PFS) of each systemic anticancer therapy and overall survival
8 months
Serious Adverse Events: Defined as AEs leading to dose adjustment, treatment interruption/ cessation or death.
8 months
Predictive factors
8 months
Co-morbidity assessed by Charlson Comorbidity Index
8 months
Combined PFS and OS on sequential treatment
8 months
- +2 more secondary outcomes
Study Arms (1)
Non-Interventional Study
Outcomes Research Study
Interventions
Eligibility Criteria
All Danish patients diagnosed with metastatic renal cell carcinoma referred to the involved centers.
You may qualify if:
- Metastatic renal cell carcinoma
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
- Copenhagen University Hospital at Herlevcollaborator
- Rigshospitalet, Denmarkcollaborator
- Aarhus University Hospitalcollaborator
- Odense University Hospitalcollaborator
- Danish Renal Cancer Study Groupcollaborator
Study Sites (1)
University of Copenhagen Herlev Hospital
Herlev, 2730, Denmark
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 15, 2011
First Posted
April 21, 2011
Study Start
April 1, 2011
Primary Completion
April 1, 2012
Study Completion
April 1, 2012
Last Updated
August 18, 2014
Record last verified: 2014-08