Sunitinib Intake Conditions in the Treatment of Patients With Renal Cell Carcinoma
1 other identifier
observational
400
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2007
Longer than P75 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2007
CompletedFirst Submitted
Initial submission to the registry
September 26, 2011
CompletedFirst Posted
Study publicly available on registry
September 28, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2012
CompletedMarch 18, 2013
September 1, 2007
4.6 years
September 26, 2011
March 15, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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)
Secondary Outcomes (3)
Progression Free survival (PFS)
2008 - 2011 (up to 3 years)
Overall Survival (OS)
2008 - 2011 (up to 3 years)
Number of patients with adverse events
2008 - 2011 (up to 3 years)
Study Arms (1)
Sunitinib Renal Cell Carcinoma
Patients diagnosed with Renal Cell Carcinoma (RCC) and treated with Sunitinib from 2008 to present will be eligible. This will include current active patients as well as patients who have expired and have medical records available.
Eligibility Criteria
Patients diagnosed with RCC and treated with Sunitinib from 2008 to present will be eligible. This will include current active patients as well as patients who have expired and have medical records available.
You may qualify if:
- Histologically or cytologically confirmed, unresectable advanced renal cell carcinoma;
- Sunitinib as first-line treatment alone or combined with other therapies.
You may not qualify if:
- History of Grade 3/4 severe allergic reaction to Sunitinib or its metabolites
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cancer Foundation, Chinalead
- Pfizercollaborator
Study Sites (2)
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021, China
Tongji Hospital, Tongji Medical College of Hust
Wuhan, Hubei, 430030, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Zhangqun Ye, MD
Tongji Hospital
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 26, 2011
First Posted
September 28, 2011
Study Start
November 1, 2007
Primary Completion
June 1, 2012
Study Completion
June 1, 2012
Last Updated
March 18, 2013
Record last verified: 2007-09