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.

August 15, 2014 updated by: Pfizer

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

No sampling. All eligible patients will be included.

Study Type

Observational

Enrollment (Actual)

1073

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Herlev, Denmark, 2730
        • University of Copenhagen Herlev Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

Metastatic renal cell carcinoma

Exclusion Criteria:

None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Non-Interventional Study
Outcomes Research Study
Other: Non-interventional
Non-interventional (retrospective chart reviews)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall survival from initiation of first systemic anticancer therapy
Time Frame: 8 months
8 months
Progression free survival from initiation of each systemic anticancer therapy separately
Time Frame: 8 months
8 months
Time to treatment failure from initiation of each systemic anticancer therapy separately
Time Frame: 8 months
8 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Prognostic factors at baseline associated with efficacy (PFS) of each systemic anticancer therapy and overall survival
Time Frame: 8 months
8 months
Serious Adverse Events: Defined as AEs leading to dose adjustment, treatment interruption/ cessation or death.
Time Frame: 8 months
8 months
Predictive factors
Time Frame: 8 months
8 months
Co-morbidity assessed by Charlson Comorbidity Index
Time Frame: 8 months
8 months
Combined PFS and OS on sequential treatment
Time Frame: 8 months
8 months
Assessment of first line immunotherapy´s effect on second line targeted therapy
Time Frame: 8 months
8 months
Assessment of prognostic factors and overall survival for patients not receiving systemic therapy
Time Frame: 8 months
8 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Collaborators

Odense University Hospital
Aarhus University Hospital
Rigshospitalet, Denmark
Copenhagen University Hospital at Herlev
Danish Renal Cancer Study Group

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2011

Primary Completion (Actual)

April 1, 2012

Study Completion (Actual)

April 1, 2012

Study Registration Dates

First Submitted

April 15, 2011

First Submitted That Met QC Criteria

April 20, 2011

First Posted (Estimate)

April 21, 2011

Study Record Updates

Last Update Posted (Estimate)

August 18, 2014

Last Update Submitted That Met QC Criteria

August 15, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A6181203
  • DARENCA STUDY 2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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