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

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ClinicalTrials.gov Identifier: NCT01441661
Recruitment Status : Completed
First Posted : September 28, 2011
Last Update Posted : March 18, 2013
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease
Renal Cell Carcinoma

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.

Study Design

Study Type : Observational
Actual Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Sunitinib Intake Conditions in the Treatment of Patients With Renal Cell Carcinoma: a Multicenter, Non-interventional, Retrospective Survey
Study Start Date : November 2007
Primary Completion Date : June 2012
Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort
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.


Outcome Measures

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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.
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01441661


Locations
China, Beijing
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing, China, 100021
China, Hubei
Tongji Hospital, Tongji Medical College of Hust
Wuhan, Hubei, China, 430030
Sponsors and Collaborators
Cancer Foundation, China
Pfizer
Investigators
Principal Investigator: Zhangqun Ye, MD Tongji Hospital
More Information

Responsible Party: Cancer Foundation, China
ClinicalTrials.gov Identifier: NCT01441661     History of Changes
Other Study ID Numbers: CFC20110815
First Posted: September 28, 2011    Key Record Dates
Last Update Posted: March 18, 2013
Last Verified: September 2007

Keywords provided by Cancer Foundation, China:
Sunitinib
kidney diseases
urogenital neoplasms
kidney cancer

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Sunitinib
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors