Non-Interventional Study Of Indian Patients With Advanced Renal Cell Cancer Receiving Therapy With Sutent

Completed

Conditions: Renal Cell Carcinoma

Interventions: Other: Non Interventional

Registration Number: NCT00836745

Lead Sponsor: Pfizer

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 36

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

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
1	Non Interventional	Non Interventional

Primary Outcome Measures

Name	Time	Method
Progression Free Survival (PFS)	Baseline until disease progression or death due to any cause or discontinuation from study treatment (up to 1 year from start of first dose)	PFS defined as the time (in weeks) from the date of first dose of sunitinib to the date of first documentation of objective tumor progression or death due to any cause, whichever occurs first. Date of first documentation of progression was based on radiological assessment of tumor measurements. PFS was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 7.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With Objective Response (OR)	Baseline until disease progression or discontinuation from study treatment (up to 1 year from start of first dose)	Percentage of participants with OR based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to response evaluation criteria in solid tumors (RECIST). Confirmed responses were those that persist on repeat imaging study at least 4 weeks after initial documentation of response. CR defined as the disappearance of all lesions (target and/or non- target). PR those with at least 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.
Number of Participants Who Required Management of Skin and Subcutaneous Tissue Related Adverse Events	Baseline up to 1 year from start of first dose	An adverse event is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Number of participants who required dose modifications and other measures for the management of skin and subcutaneous tissue related adverse events were presented.
Number of Participants Who Required Management of Other Adverse Events	Baseline up to 1 year from start of first dose	An adverse event is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Number of participants who required dose modifications and other measures for the management of other adverse events were to be presented.