SUTENT® In The First Line Treatment Of Renal Cell Carcinoma (SUNIKA)
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
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||A Non-Interventional Study With SUTENT® In The First Line Treatment Of Renal Cell Cancer|
- Number of Participants With Categorical Best Overall Response [ Time Frame: Start of Treatment up through 12 Months or Early Discontinuation ] [ Designated as safety issue: No ]Best overall reponse based on investigator's disease status assessment. Complete response(CR)=disappearance of all target lesions.Partial Response(PR)=≥30% decrease in sum of longest dimensions of lesions taking as reference baseline sum longest dimensions.Progressive disease(PD)=≥20% increase in sum of longest dimensions of lesions taking as a reference smallest sum of longest dimensions since treatment start or appearance of ≥1 new lesions. Stable disease(SD)=neither shrinkage for PR or increase for PD taking as reference smallest sum of longest dimensions since treatment start.
- Number of Participants With Objective Response [ Time Frame: 12 Months or Early Discontinuation ] [ Designated as safety issue: No ]Objective response (CR or PR) based on investigator's overall objective tumor assessment at final visit according to Response Evaluation Criteria in Solid Tumors (RECIST). CR was defined as disappearance of all target lesions. PR was defined as a ≥30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.
- Time to Progression (TTP) [ Time Frame: Start of Treatment up through 12 Months or Early Discontinuation ] [ Designated as safety issue: No ]TTP = time from date of first dose to date of first recording of PD. Participants who did not have a recorded PD at any of the visits or at Overall Objective Tumor Assessment at 12 months were treated as censored at the date of the last available follow up for disease response/tumor assessment.
- Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status [ Time Frame: Baseline, 3, 6, 9 and 12 Months ] [ Designated as safety issue: No ]ECOG performance status measured on 6 point scale to assess participant's performance status. 0=Fully active, able to carry on all pre-disease activities without restriction; 1=Restricted in physically strenuous activity, ambulatory and able to carry out light or sedentary work; 2=Ambulatory (>50% of waking hours), capable of all self care, unable to carry out any work activities; 3=Capable of only limited self care, confined to bed/chair >50% of waking hours; 4=Completely disabled, cannot carry on any self care, totally confined to bed/chair; 5=Dead. 0=Best status, 5=Worst status
- European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Scores [ Time Frame: Baseline, 3, 6, 9 and 12 Months ] [ Designated as safety issue: No ]EORTC QLQ-C30: 5 functional scales (physical, role, cognitive, emotional, and social), a global health status/quality of life (QoL) scale, 3 symptom scales (nausea and vomiting, pain, fatigue) and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea and financial difficulties). All scales and single-item measures range=0 to 100. High score for a functional scale=high/healthy level of functioning. High score for global health status/QoL=high QoL. High score for symptom scale/single item=high level of symptomatology/problems
|Study Start Date:||February 2007|
|Study Completion Date:||September 2009|
|Primary Completion Date:||September 2009 (Final data collection date for primary outcome measure)|
Other: Sutent: observational study
SUNIKA - A Non-Interventional Study With SUTENT® In The First Line Treatment Of Renal Cell Carcinoma
Other Name: sunitinib malate
The Statistical Analysis Plan provides detailed specification of the analysis