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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01441661

Enrollment

400

Registered

2011-09-28

Start date

2007-11-30

Completion date

2012-06-30

Last updated

2013-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Renal Cell Carcinoma

Keywords

Sunitinib, kidney diseases, urogenital neoplasms, kidney cancer

Brief summary

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.

Detailed description

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Disease control rate (DCR)	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

Measure	Time frame	Description
Progression Free survival (PFS)	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)	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	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.

Countries

China

Outcome results