Tumor Registry of Advanced Renal Cell Carcinoma - Full Text View

Tumor Registry of Advanced Renal Cell Carcinoma (RCC-Registry)

This study is currently recruiting participants.

Verified December 2011 by iOMEDICO AG

First Received on January 25, 2008. Last Updated on December 21, 2011 History of Changes

Sponsor:	iOMEDICO AG
Collaborators:	Arbeitskreis Klinische Studien BayerVital GmbH Bund der Urologen e.G. Novartis Pharmaceuticals Roche Pharma AG Pfizer GlaxoSmithKline
Information provided by:	iOMEDICO AG
ClinicalTrials.gov Identifier:	NCT00610012

Purpose

The purpose of this registry is to record information of therapy reality of metastatic or locally advanced Renal Cell Carcinoma in Germany. The outcome of this registry will describe the changes of the used therapies within 7 years. It will give conclusions about course of disease and therapy sequences. Based on the data a prognostic score will be developed.

Condition
Renal Cell Carcinoma

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	Epidemiological Registry Describing Treatment Reality and Therapy Modality of Patients With Metastatic or Locally Advanced Renal Cell Carcinoma Requiring Therapy

Resource links provided by NLM:

MedlinePlus related topics: Cancer

U.S. FDA Resources

Further study details as provided by iOMEDICO AG:

Primary Outcome Measures:

Documentation of therapies [ Time Frame: 7 years, 3 years per patient ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Documentation of response rate and adverse reactions; development of a numeric prognostic score [ Time Frame: 7 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	1000
Study Start Date:	December 2007
Estimated Primary Completion Date:	December 2014 (Final data collection date for primary outcome measure)

Groups/Cohorts
Advanced RCC Patients with metastatic or locally advanced Renal Cell Carcinoma requiring therapy

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

Practitioners specialized in oncology and urology in Germany

Criteria

Inclusion Criteria:

Patients with metastatic or locally advanced Renal Cell Carcinoma requiring therapy
Start of first palliative therapy within 1 year before enrollment of patient to registry

Exclusion Criteria:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00610012

Locations

Germany
iOMEDICO	Recruiting
Freiburg, Germany
Contact: iOMEDICO AG +49 761 152420 info@iomedico.com

Sponsors and Collaborators

iOMEDICO AG

Arbeitskreis Klinische Studien

BayerVital GmbH

Bund der Urologen e.G.

Novartis Pharmaceuticals

Roche Pharma AG

Pfizer

GlaxoSmithKline

More Information

Publications:

Motzer RJ, Bacik J, Schwartz LH, Reuter V, Russo P, Marion S, Mazumdar M. Prognostic factors for survival in previously treated patients with metastatic renal cell carcinoma. J Clin Oncol. 2004 Feb 1;22(3):454-63.

Garcia JA, Rini BI. Recent progress in the management of advanced renal cell carcinoma. CA Cancer J Clin. 2007 Mar-Apr;57(2):112-25. Review.

Fyfe G, Fisher RI, Rosenberg SA, Sznol M, Parkinson DR, Louie AC. Results of treatment of 255 patients with metastatic renal cell carcinoma who received high-dose recombinant interleukin-2 therapy. J Clin Oncol. 1995 Mar;13(3):688-96.

Escudier B, Chevreau C, Lasset C, Douillard JY, Ravaud A, Fabbro M, Caty A, Rossi JF, Viens P, Bergerat JP, Savary J, Négrier S. Cytokines in metastatic renal cell carcinoma: is it useful to switch to interleukin-2 or interferon after failure of a first treatment? Groupe Français d'Immunothérape. J Clin Oncol. 1999 Jul;17(7):2039-43.

Motzer RJ, Bacik J, Murphy BA, Russo P, Mazumdar M. Interferon-alfa as a comparative treatment for clinical trials of new therapies against advanced renal cell carcinoma. J Clin Oncol. 2002 Jan 1;20(1):289-96.

Motzer RJ, Michaelson MD, Redman BG, Hudes GR, Wilding G, Figlin RA, Ginsberg MS, Kim ST, Baum CM, DePrimo SE, Li JZ, Bello CL, Theuer CP, George DJ, Rini BI. Activity of SU11248, a multitargeted inhibitor of vascular endothelial growth factor receptor and platelet-derived growth factor receptor, in patients with metastatic renal cell carcinoma. J Clin Oncol. 2006 Jan 1;24(1):16-24. Epub 2005 Dec 5.

Motzer RJ, Hutson TE, Tomczak P, Michaelson MD, Bukowski RM, Rixe O, Oudard S, Negrier S, Szczylik C, Kim ST, Chen I, Bycott PW, Baum CM, Figlin RA. Sunitinib versus interferon alfa in metastatic renal-cell carcinoma. N Engl J Med. 2007 Jan 11;356(2):115-24.

Escudier B, Eisen T, Stadler WM, Szczylik C, Oudard S, Siebels M, Negrier S, Chevreau C, Solska E, Desai AA, Rolland F, Demkow T, Hutson TE, Gore M, Freeman S, Schwartz B, Shan M, Simantov R, Bukowski RM; TARGET Study Group. Sorafenib in advanced clear-cell renal-cell carcinoma. N Engl J Med. 2007 Jan 11;356(2):125-34.

Amato RJ, Harris P, Dalton M, Khan M, Alter R, Zhai Q, Brady JR, Jac J, Hauke R, Srinivas S. The Methodist Hospital Research Institute, Houston, TX, United States. A phase II trial of intra-patient dose-escalated sorafenib in patients (pts) with metastatic renal cell cancer (MRCC). ASCO 2007, Abstract 5026

Responsible Party:	iOMEDICO AG
ClinicalTrials.gov Identifier:	NCT00610012 History of Changes
Other Study ID Numbers:	IOM RCC
Study First Received:	January 25, 2008
Last Updated:	December 21, 2011
Health Authority:	Germany: Ethics Commission

Keywords provided by iOMEDICO AG:

Advanced Renal Cell Carcinoma
MRCC
Therapy-reality
Observation
Registry
RCC
ARCC
Germany
Metastatic Renal Cell Carcinoma

Renal Cell Carcinoma
Renal Cell Cancer
Sorafenib
Sunitinib
Interferon
Interleukin
Cytokines
VEGF

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 February 09, 2012