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NCT01339962 Clinical Trial

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.

Renal Cell Carcinoma Clinical Trial

Official title:
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.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01339962
Other study ID # A6181203
Secondary ID DARENCA STUDY 2
Status Completed
Phase Phase 4
First received April 15, 2011
Last updated August 15, 2014
Start date April 2011
Est. completion date April 2012

Study information
Verified date August 2014
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Observational

Clinical Trial 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.

Description:

No sampling. All eligible patients will be included.

Recruitment information / eligibility
Status Completed
Enrollment 1073
Est. completion date April 2012
Est. primary completion date April 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

Metastatic renal cell carcinoma

Exclusion Criteria:

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

Intervention

Other:
• Non-interventional
Non-interventional (retrospective chart reviews)

Locations
Country Name City State
Denmark University of Copenhagen Herlev Hospital Herlev

Sponsors (6)
Lead Sponsor Collaborator
Pfizer Aarhus University Hospital, Copenhagen University Hospital at Herlev, Danish Renal Cancer Study Group, Odense University Hospital, Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary Overall survival from initiation of first systemic anticancer therapy 8 months No
Primary Progression free survival from initiation of each systemic anticancer therapy separately 8 months No
Primary Time to treatment failure from initiation of each systemic anticancer therapy separately 8 months No
Secondary Prognostic factors at baseline associated with efficacy (PFS) of each systemic anticancer therapy and overall survival 8 months No
Secondary Serious Adverse Events: Defined as AEs leading to dose adjustment, treatment interruption/ cessation or death. 8 months Yes
Secondary Predictive factors 8 months No
Secondary Co-morbidity assessed by Charlson Comorbidity Index 8 months No
Secondary Combined PFS and OS on sequential treatment 8 months No
Secondary Assessment of first line immunotherapy´s effect on second line targeted therapy 8 months No
Secondary Assessment of prognostic factors and overall survival for patients not receiving systemic therapy 8 months No
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