跳至主要内容
临床试验/NCT00460798
NCT00460798已完成不适用

A Non-Interventional Study With SUTENT® In The First Line Treatment Of Renal Cell Cancer

Pfizer0 个研究点目标入组 356 人开始时间: 2007年2月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
Pfizer
入组人数
356
主要终点
Number of Participants With Categorical Best Overall Response

研究概览

简要总结

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.

详细描述

The Statistical Analysis Plan provides detailed specification of the analysis

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

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

排除标准

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

结局指标

主要结局

Number of Participants With Categorical Best Overall Response

时间窗: Start of Treatment up through 12 Months or Early Discontinuation

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

时间窗: 12 Months or Early Discontinuation

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)

时间窗: Start of Treatment up through 12 Months or Early Discontinuation

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

时间窗: Baseline, 3, 6, 9 and 12 Months

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

时间窗: Baseline, 3, 6, 9 and 12 Months

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

次要结局

未报告次要终点

研究者

发起方
Pfizer
申办方类型
Industry

相似试验

SUTENT® In The First Line Treatment Of Renal Cell... | 临床试验