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.
Verified date | August 2014 |
Source | Pfizer |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Observational |
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.
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: |
Observational Model: Cohort, Time Perspective: Retrospective
Country | Name | City | State |
---|---|---|---|
Denmark | University of Copenhagen Herlev Hospital | Herlev |
Lead Sponsor | Collaborator |
---|---|
Pfizer | Aarhus University Hospital, Copenhagen University Hospital at Herlev, Danish Renal Cancer Study Group, Odense University Hospital, Rigshospitalet, Denmark |
Denmark,
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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