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.

Completed

• Conditions: Renal Cell Carcinoma
• Interventions: Other: Non-interventional

• Registration Number: NCT01339962
• Lead Sponsor: Pfizer

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.

Detailed Description

No sampling. All eligible patients will be included.

Study Timeline

• Study Start: 2011-04
• Study First Submitted: 2011-04-15
• Study First Submitted QC: 2011-04-20
• Study First Posted: 2011-04-21
• Primary Completion: 2012-04
• Study Completion: 2012-04
• Status Verified: 2014-08
• Last Update Submitted: 2014-08-15
• Last Update Posted: 2014-08-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1073

Inclusion Criteria

Metastatic renal cell carcinoma

Exclusion Criteria

None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Non-Interventional Study	Non-interventional	Outcomes Research Study

Primary Outcome Measures

Name	Time	Method
Progression free survival from initiation of each systemic anticancer therapy separately	8 months
Overall survival from initiation of first systemic anticancer therapy	8 months
Time to treatment failure from initiation of each systemic anticancer therapy separately	8 months

Secondary Outcome Measures

Name	Time	Method
Predictive factors	8 months
Assessment of prognostic factors and overall survival for patients not receiving systemic therapy	8 months
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
Co-morbidity assessed by Charlson Comorbidity Index	8 months
Combined PFS and OS on sequential treatment	8 months
Assessment of first line immunotherapy´s effect on second line targeted therapy	8 months

Trial Locations

Locations (1)

University of Copenhagen Herlev Hospital; 🇩🇰 Herlev, Denmark