Patterns Of Care Among Australian Cohort Of Patients With Advanced Rrc Receiving Sutent
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 212
- 主要终点
- Progression-Free Survival (PFS) From Initiation of Sutent Therapy
研究概览
简要总结
This is a retrospective, non-interventional study which looks at the cohort of Renal Cell Carcinoma patients in a real life clinical setting and analyses into factors why these patients have been surviving for as long as 3-5 years unlike Clinical study where the survival is around 2 years.
The factors which will be analysed include patient characteristics, dosage and adverse event management and tries to correlate these factors with survival.
详细描述
A single cohort of 200 patients who are diagnosed with metastatic renal cell carcinoma prior to 1st Jan 2012, and are seen by the medical oncologist at the centers involved with BIOGRID and its affiliated registries. Patients will be identified from the first date of their consultation with the medical oncologist and captured in the electronic database. Consent to use datasets has already been obtained from participating research institutes and hospitals IRB/Ethics Committees
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female
- •Metastatic renal cell cancer
- •First presentation with metastatic disease prior to 1st Jan 2012 since 2006, i.e. between 1st Jan 2006 to 31st Dec 2011
排除标准
- •No referral to medical oncologist
- •No record available in electronic database
结局指标
主要结局
Progression-Free Survival (PFS) From Initiation of Sutent Therapy
时间窗: From initiation of treatment up to 72 months
PFS was defined as the time from initiation of Sutent (sunitinib malate) to first documentation of tumor progression or to death due to any cause, whichever occurred first. Time to treatment failure was used as a surrogate for PFS as PFS could not be determined due to retrospective nature of this study.
次要结局
- Objective Response Rate - Percentage of Participants With Objective Response From Initiation of Sutent Therapy(From initiation of treatment up to 72 months)
- Overall Survival (OS)(From diagnosis until death (up to 72 months))
- Time to Treatment Failure From Initiation of Sutent Therapy(From initiation of treatment up to 72 months)
- Correlation of Dosage and Number of Participants With CR (Complete Response), PR (Partial Response), SD (Stable Disease) and PD (Progressive Disease) From Initiation of Sutent Therapy(From initiation of treatment up to 72 months)
- Correlation of Duration and Number of Participants With CR (Complete Response), PR (Partial Response), SD (Stable Disease) and PD (Progressive Disease) From Initiation of Sutent Therapy(From initiation of treatment up to 72 months)