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Completed

NCT Number: NCT01339962

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.

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.

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Key information

Conditions

Renal Cell Carcinoma Adenocarcinoma Carcinoma Carcinoma, Renal Cell Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Copenhagen Herlev Hospital

Herlev, 2730, Denmark

About this study

No sampling. All eligible patients will be included.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Metastatic renal cell carcinoma

Exclusion criteria

None

Treatment and study plan

Non-Interventional

Other

Non-interventional (retrospective chart reviews)

Primary outcomes

  1. Overall survival from initiation of first systemic anticancer therapy

    Time frame: 8 months

  2. Progression free survival from initiation of each systemic anticancer therapy separately

    Time frame: 8 months

  3. Time to treatment failure from initiation of each systemic anticancer therapy separately

    Time frame: 8 months

Secondary outcomes

  1. Prognostic factors at baseline associated with efficacy (PFS) of each systemic anticancer therapy and overall survival

    Time frame: 8 months

  2. Serious Adverse Events: Defined as AEs leading to dose adjustment, treatment interruption/ cessation or death.

    Time frame: 8 months

  3. Predictive factors

    Time frame: 8 months

  4. Co-morbidity assessed by Charlson Comorbidity Index

    Time frame: 8 months

  5. Combined PFS and OS on sequential treatment

    Time frame: 8 months

  6. Assessment of first line immunotherapy´s effect on second line targeted therapy

    Time frame: 8 months

  7. Assessment of prognostic factors and overall survival for patients not receiving systemic therapy

    Time frame: 8 months

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Collaborators

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

Registry information

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Apr 21, 2011
Registry last updated
Aug 18, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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