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.

This study has been completed.
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
ClinicalTrials.gov Identifier:
NCT01339962
First received: April 15, 2011
Last updated: August 15, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention Phase
Renal Cell Carcinoma
Other: Non-interventional
Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
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.

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Overall survival from initiation of first systemic anticancer therapy [ Time Frame: 8 months ] [ Designated as safety issue: No ]
  • Progression free survival from initiation of each systemic anticancer therapy separately [ Time Frame: 8 months ] [ Designated as safety issue: No ]
  • Time to treatment failure from initiation of each systemic anticancer therapy separately [ Time Frame: 8 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Prognostic factors at baseline associated with efficacy (PFS) of each systemic anticancer therapy and overall survival [ Time Frame: 8 months ] [ Designated as safety issue: No ]
  • Serious Adverse Events: Defined as AEs leading to dose adjustment, treatment interruption/ cessation or death. [ Time Frame: 8 months ] [ Designated as safety issue: Yes ]
  • Predictive factors [ Time Frame: 8 months ] [ Designated as safety issue: No ]
  • Co-morbidity assessed by Charlson Comorbidity Index [ Time Frame: 8 months ] [ Designated as safety issue: No ]
  • Combined PFS and OS on sequential treatment [ Time Frame: 8 months ] [ Designated as safety issue: No ]
  • Assessment of first line immunotherapy´s effect on second line targeted therapy [ Time Frame: 8 months ] [ Designated as safety issue: No ]
  • Assessment of prognostic factors and overall survival for patients not receiving systemic therapy [ Time Frame: 8 months ] [ Designated as safety issue: No ]

Enrollment: 1073
Study Start Date: April 2011
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Non-Interventional Study
Outcomes Research Study
Other: Non-interventional
Non-interventional (retrospective chart reviews)

Detailed Description:

No sampling. All eligible patients will be included.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

All Danish patients diagnosed with metastatic renal cell carcinoma referred to the involved centers.

Criteria

Inclusion Criteria:

Metastatic renal cell carcinoma

Exclusion Criteria:

None

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01339962

Locations
Denmark
University of Copenhagen Herlev Hospital
Herlev, Denmark, 2730
Sponsors and Collaborators
Pfizer
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
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01339962     History of Changes
Other Study ID Numbers: A6181203, DARENCA STUDY 2
Study First Received: April 15, 2011
Last Updated: August 15, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Metastatic renal cell carcinoma

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on August 28, 2014