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

NCT01441661

Last updated date
Study Location
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing, 100021, China
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Renal Cell Carcinoma
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
0 +
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Histologically or cytologically confirmed, unresectable advanced renal cell carcinoma;

- Sunitinib as first-line treatment alone or combined with other therapies.

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


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

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Advanced Information
Descriptive Information
Brief Title Sunitinib Intake Conditions in the Treatment of Patients With Renal Cell Carcinoma
Official Title Sunitinib Intake Conditions in the Treatment of Patients With Renal Cell Carcinoma: a Multicenter, Non-interventional, Retrospective Survey
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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Renal Cell Carcinoma
Intervention Not Provided
Study Groups/Cohorts 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: September 27, 2011)
400
Original Estimated Enrollment Same as current
Actual Study Completion Date June 2012
Actual Primary Completion Date June 2012   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study:All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT01441661
Other Study ID Numbers CFC20110815
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Cancer Foundation, China
Study Sponsor Cancer Foundation, China
Collaborators Pfizer
Investigators
Principal Investigator:Zhangqun Ye, MDTongji Hospital
PRS Account Cancer Foundation, China
Verification Date September 2007