SUTENT® In The First Line Treatment Of Renal Cell Carcinoma

NCT00460798

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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

- First-line treatment in patients with metastatic renal cell carcinoma

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


- Any previous systemic therapy of renal cell carcinoma except for adjuvant treatment

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Advanced Information
Descriptive Information
Brief Title SUTENT® In The First Line Treatment Of Renal Cell Carcinoma
Official Title A Non-Interventional Study With SUTENT® In The First Line Treatment Of Renal Cell Cancer
Brief Summary

This non-interventional study includes patients with advanced and/or metastatic renal cell carcinoma who are treated with SUTENT and who did not receive any other systemic therapy before. The aim of the trial is to increase knowledge about quality of life, safety, efficacy and tolerability under conditions of routine use of Sutent. The individual observation period of each patient will be

1 year.

Detailed Description The Statistical Analysis Plan provides detailed specification of the analysis
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients treated by office-based oncologists, office-based urologists specialized in oncology or hospital-based oncologist/urologists
Condition Renal Cell Carcinoma
Intervention Other: Sutent: observational study
SUNIKA - A Non-Interventional Study With SUTENT® In The First Line Treatment Of Renal Cell Carcinoma
Other Name: sunitinib malate
Study Groups/Cohorts Non-Interventional Study
Intervention: Other: Sutent: observational study
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: November 3, 2010)
356
Original Enrollment
 (submitted: April 13, 2007)
600
Actual Study Completion Date September 2009
Actual Primary Completion Date September 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • First-line treatment in patients with metastatic renal cell carcinoma

Exclusion Criteria:

  • Any previous systemic therapy of renal cell carcinoma except for adjuvant treatment
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 Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT00460798
Other Study ID Numbers A6181115
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer Inc
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date November 2010