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

• Carcinoma
• Carcinoma, Renal Cell
• Renal Cell Carcinoma

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

External Links

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