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Trial record 1 of 1 for:    NCT01339962
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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.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01339962
Recruitment Status : Completed
First Posted : April 21, 2011
Last Update Posted : August 18, 2014
Sponsor:
Collaborators:
Copenhagen University Hospital at Herlev
Rigshospitalet, Denmark
Aarhus University Hospital
Odense University Hospital
Danish Renal Cancer Study Group
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date April 15, 2011
First Posted Date April 21, 2011
Last Update Posted Date August 18, 2014
Study Start Date April 2011
Actual Primary Completion Date April 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 26, 2011)
  • Overall survival from initiation of first systemic anticancer therapy [ Time Frame: 8 months ]
  • Progression free survival from initiation of each systemic anticancer therapy separately [ Time Frame: 8 months ]
  • Time to treatment failure from initiation of each systemic anticancer therapy separately [ Time Frame: 8 months ]
Original Primary Outcome Measures
 (submitted: April 20, 2011)
  • Progression free survival from initiation of each systemic anticancer therapy separately [ Time Frame: 6 months ]
  • Overall survival from initiation for first systemic anticancer therapy [ Time Frame: 6 months ]
Change History Complete list of historical versions of study NCT01339962 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: May 26, 2011)
  • Prognostic factors at baseline associated with efficacy (PFS) of each systemic anticancer therapy and overall survival [ Time Frame: 8 months ]
  • Serious Adverse Events: Defined as AEs leading to dose adjustment, treatment interruption/ cessation or death. [ Time Frame: 8 months ]
  • Predictive factors [ Time Frame: 8 months ]
  • Co-morbidity assessed by Charlson Comorbidity Index [ Time Frame: 8 months ]
  • Combined PFS and OS on sequential treatment [ Time Frame: 8 months ]
  • Assessment of first line immunotherapy´s effect on second line targeted therapy [ Time Frame: 8 months ]
  • Assessment of prognostic factors and overall survival for patients not receiving systemic therapy [ Time Frame: 8 months ]
Original Secondary Outcome Measures
 (submitted: April 20, 2011)
  • Prognostic factors at baseline associated with efficacy (PFS) of each systemic anticancer therapy and overall survival [ Time Frame: 6 months ]
  • Serious Adverse Events: Defined as AEs leading to dose adjustment, treatment interruption/ cessation or death. [ Time Frame: 6 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief 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.
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.
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population All Danish patients diagnosed with metastatic renal cell carcinoma referred to the involved centers.
Condition Renal Cell Carcinoma
Intervention Other: Non-interventional
Non-interventional (retrospective chart reviews)
Study Groups/Cohorts Non-Interventional Study
Outcomes Research Study
Intervention: Other: Non-interventional
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: June 25, 2012)
1073
Original Estimated Enrollment
 (submitted: April 20, 2011)
600
Actual Study Completion Date April 2012
Actual Primary Completion Date April 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

Metastatic renal cell carcinoma

Exclusion Criteria:

None

Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Denmark
Removed Location Countries  
 
Administrative Information
NCT Number NCT01339962
Other Study ID Numbers A6181203
DARENCA STUDY 2
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators
  • Copenhagen University Hospital at Herlev
  • Rigshospitalet, Denmark
  • Aarhus University Hospital
  • Odense University Hospital
  • Danish Renal Cancer Study Group
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date August 2014