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OpenTrials
Completed

NCT Number: NCT00895674

Patient Characteristics in Advanced Renal Cell Carcinoma and Daily Practice Treatment With Nexavar

Renal cell carcinoma accounts for roughly 3 % of all cancer. It is a rather aggressive cancer type, which means that patients who present with an advanced disease have a rather poor prognosis. When this study has been started the standard therapy for patients has been cytokines, which might be accompanied by significant toxicities or might fail the therapeutic goal. In these cases sorafenib can be a feasible therapeutic option. This non-interventional study has been created and is being conducted to collect clinical data on the patients' therapy with sorafenib in an everyday treatment schedule. The main goal of this study focuses on patient characteristics and tumor status in RCC treated with sorafenib as well as the treatment duration and safety of sorafenib under everyday treatment conditions.

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Key information

Conditions

Carcinoma, Renal Cell Adenocarcinoma Carcinoma Carcinoma, Renal Cell (Advanced) 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

Many Locations, Argentina

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with diagnosis of advanced RCC and decision taken by the investigator to prescribe Sorafenib

Exclusion criteria

  • Exclusion criteria must be read in conjunction with the local product information

Treatment and study plan

Nexavar (Sorafenib, BAY43-9006)

Drug

Patients with a diagnosis of advanced RCC

Primary outcomes

  1. Tumor status

    Time frame: After about 3, 6, 9 and 12 months

Secondary outcomes

  1. Treatment duration

    Time frame: At end of study after about 12 months

  2. Safety of sorafenib treatment

    Time frame: At every documented visit for about 12 months

  3. Progression-free survival

    Time frame: Calculation at end of study after about 12 months

  4. Status of Metastases

    Time frame: After about 3, 6, 9 and 12 months

  5. Performance status (ECOG)

    Time frame: After about 3, 6, 9 and 12 months

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Important dates

Study start
2006
Primary completion
2010
Study completion
2010
First posted
May 8, 2009
Registry last updated
Sep 30, 2010

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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