Clinical trial NCT00836745: Non-Interventional Study Of Indian Patients With Advanced Renal Cell Cancer Receiving Therapy With Sutent
Official title: Non-Interventional Study Of Indian Patients With Advanced Renal Cell Cancer Receiving Therapy With Sutent
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Renal Cell Carcinoma
Keywords: Advanced renal cell Cancer
Non interventional study
Renal Cancer
Sutent
Metastatic
Advanced Renal Cell Carcinoma
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-02-04
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients with advanced renal cell cancer in the treatment naïve or cytokine refractory settings prescribed Sutent® will be eligible for the study.

Brief summary: The Sutent® Observational Study is being proposed to assess the real-world usage patterns and effectiveness and tolerability of treatment of Indian patients with advanced renal cell cancer with Sutent®. Generation of such information is expected to aid everyday clinical decision-making by Indian doctors and will add to the body of generalizable evidence.

Detailed description: The assignment of the patient to Sutent® treatment is not decided in advance by this noninterventional study protocol, but falls within current practice. The decision to prescribe Sutent® is clearly not driven by the decision to include the patient in this study.The sample size for this study is not based on statistical considerations. It is expected that a minimum of 100 patients will be enrolled in the study by the end of the first year and the data collected would be adequate to fulfill the observational objectives of the study.The study will be initiated at 10 sites across India during the 1st year. The study may be expanded with the addition of new sites during the 2nd year.

Eligibility criteria: Inclusion Criteria:

* Patients with advanced renal cell cancer
* Treatment naïve or cytokine refractory

Exclusion Criteria:

* Patients presenting with a known hypersensitivity to Sunitinib or its metabolites

Primary outcomes:
measure: Progression Free Survival (PFS)
timeFrame: Baseline until disease progression or death due to any cause or discontinuation from study treatment (up to 1 year from start of first dose)
Secondary outcomes:
measure: Percentage of Participants With Objective Response (OR)
timeFrame: Baseline until disease progression or discontinuation from study treatment (up to 1 year from start of first dose)
measure: Number of Participants Who Required Management of Skin and Subcutaneous Tissue Related Adverse Events
timeFrame: Baseline up to 1 year from start of first dose
measure: Number of Participants Who Required Management of Other Adverse Events
timeFrame: Baseline up to 1 year from start of first dose
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Pfizer Investigational Site
state: Delhi
city: Bangalore
country: India
facility: Pfizer Investigational Site
state: Karnataka
city: Mumbai
country: India
facility: Pfizer Investigational Site
state: Maharashtra
city: Chandigard
country: India
facility: Pfizer Investigational Site
state: Punjab
city: Kolkata
country: India
facility: Pfizer Investigational Site
state: West Bengal
city: Delhi
country: India
facility: Pfizer Investigational Site
city: Jaipur
country: India
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: