Sunitinib Intake Conditions in the Treatment of Patients With Renal Cell Carcinoma

This non-interventional study includes patients with advanced renal cell carcinoma who are treated with Sunitinib alone or combined with other systemic therapies. The aim of the trial is to increase knowledge about usage, dosage, efficacy and safety under conditions of routine use of Sunitinib.

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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

Sex eligibility

All sexes

Study type

Observational

Primary location

Cancer Institute and Hospital, Chinese Academy of Medical Sciences, Beijing, Beijing Municipality, China

About this study

Because State Food and Drug Administration (SFDA) exempted manufacturers from conducting clinical trials of Sunitinib in China, overall efficacy and safety data of Sunitinib in Chinese patients with renal cell carcinoma were deficiency. The investigators carried out this research project will be sufficient evidence, and help clinicians in China to make decision in real daily practice.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Histologically or cytologically confirmed, unresectable advanced renal cell carcinoma;
Sunitinib as first-line treatment alone or combined with other therapies.

Exclusion criteria

History of Grade 3/4 severe allergic reaction to Sunitinib or its metabolites

Treatment and study plan

Primary outcomes

Disease control rate (DCR)

Time frame: 2008-2011 (up to 3 years)
- To determine the Disease control rate (DCR) defined as the percentage of patients who have a partial response (CR) or complete response (PR) to Sunitinib plus those whose disease is stable (DS).
- To determine the Objective Responsive Rate (ORR) defined as the percentage of patients who have a partial response (PR) or complete response (CR) to Sunitinib.

Secondary outcomes

Progression Free survival (PFS)

Time frame: 2008 - 2011 (up to 3 years)
- To assess the Progression Free survival (PFS) as defined by time interval from date of first dose of Sunitinib to date of the progression of cancer or date of death due to any reasons whichever appears earlier.
Overall Survival (OS)

Time frame: 2008 - 2011 (up to 3 years)
- To evaluate Overall Survival (OS) as defined by time interval from date of first dose of Sunitinib to date of death due to any reason.
Number of patients with adverse events

Time frame: 2008 - 2011 (up to 3 years)
- To evaluate Safety of Sunitinib. Adverse events were graded according to the National Cancer Institute issued the Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0.

Sponsors and collaborators

Lead sponsor

Cancer Foundation, China

Other

Collaborators

Pfizer

Registry information

Official study title

Sunitinib Intake Conditions in the Treatment of Patients With Renal Cell Carcinoma: a Multicenter, Non-interventional, Retrospective Survey

Important dates

Study start: 2007
Primary completion: 2012
Study completion: 2012
First posted: Sep 28, 2011
Registry last updated: Mar 18, 2013

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.

Published trials that share one or more normalized conditions with this study.

Completed