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

Renal Cell Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01441661
• Other study ID #: CFC20110815
• Status: Completed
• Phase: N/A
• First received: September 26, 2011
• Last updated: March 15, 2013
• Start date: November 2007
• Est. completion date: June 2012

Study information

• Verified date: September 2007
• Source: Cancer Foundation, China
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Renal Cell
• Renal Cell Carcinoma

Locations

Country	Name	City	State
China	Cancer Institute and Hospital, Chinese Academy of Medical Sciences	Beijing	Beijing
China	Tongji Hospital, Tongji Medical College of Hust	Wuhan	Hubei

Sponsors (2)

Lead Sponsor	Collaborator
Cancer Foundation, China	Pfizer

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease control rate (DCR)	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.	2008-2011 (up to 3 years)	No
Secondary	Progression Free survival (PFS)	• 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.	2008 - 2011 (up to 3 years)	No
Secondary	Overall Survival (OS)	• 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.	2008 - 2011 (up to 3 years)	No
Secondary	Number of patients with adverse events	• 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.	2008 - 2011 (up to 3 years)	Yes