Clinical Outcomes and Therapy Management Among Patients With Advanced Renal Cell Carcinoma (aRCC) Receiving Systemic First-line (1L) Anti-cancer Treatment Under Daily Routine in Germany: Retrospective Chart Review (RENALISTIC Study)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Pfizer
- 入组人数
- 106
- 试验地点
- 1
- 主要终点
- Progression Free Survival (PFS)
研究概览
简要总结
The purpose of this study is to learn about the treatments used in for advanced renal cell carcinoma as well as effectiveness of these treatments in the real world. Study participants must be:
At least 18 years of age or older. Confirmed renal cell carcinoma Received first line treatment
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Participants diagnosed with locally advanced or metastatic renal cell carcinoma
- •Participants with full medical information is available regarding all treatments before, during and after 1st line
排除标准
- 未提供
结局指标
主要结局
Progression Free Survival (PFS)
时间窗: From treatment initiation date until PD, death or end of follow-up period whichever was earlier (maximum follow-up of 47.1 months)
PFS was defined as time from treatment initiation of systemic 1-L therapy start date to documented date of tumor progression or date of death. Disease progression (PD) was defined as greater than equal to (\>=) 20% increase in sum of diameters of the target lesions taking as reference the smallest sum on study (this included the baseline sum if that was the smallest on study) or unequivocal progression in non-target lesions or appearance of 1 or more new lesions. Analysis was performed by Kaplan-Meier method.
PFS Rate at Month 9
时间窗: 9 months post treatment initiation date (during maximum follow-up of 47.1 months)
PFS was defined as time from treatment initiation of systemic 1-L therapy start date to documented date of tumor progression or date of death. Disease progression (PD) was defined as greater than equal to (\>=) 20% increase in sum of diameters of the target lesions taking as reference the smallest sum on study (this included the baseline sum if that was the smallest on study) or unequivocal progression in non-target lesions or appearance of 1 or more new lesions. PFS rate was percentage of participants with PFS.
PFS Rate at Month 6
时间窗: 6 months post treatment initiation date (during maximum follow-up of 47.1 months)
PFS was defined as time from treatment initiation of systemic 1-L therapy start date to documented date of tumor progression or date of death. Disease progression (PD) was defined as greater than equal to (\>=) 20% increase in sum of diameters of the target lesions taking as reference the smallest sum on study (this included the baseline sum if that was the smallest on study) or unequivocal progression in non-target lesions or appearance of 1 or more new lesions. PFS rate was percentage of participants with PFS.
PFS Rate at Month 12
时间窗: 12 months post treatment initiation date (during maximum follow-up of 47.1 months)
PFS was defined as time from treatment initiation of systemic 1-L therapy start date to documented date of tumor progression or date of death. Disease progression (PD) was defined as greater than equal to (\>=) 20% increase in sum of diameters of the target lesions taking as reference the smallest sum on study (this included the baseline sum if that was the smallest on study) or unequivocal progression in non-target lesions or appearance of 1 or more new lesions. PFS rate was percentage of participants with PFS.
PFS Rate at Month 18
时间窗: 18 months post treatment initiation date (during maximum follow-up of 47.1 months)
PFS was defined as time from treatment initiation of systemic 1-L therapy start date to documented date of tumor progression or date of death. Disease progression (PD) was defined as greater than equal to (\>=) 20% increase in sum of diameters of the target lesions taking as reference the smallest sum on study (this included the baseline sum if that was the smallest on study) or unequivocal progression in non-target lesions or appearance of 1 or more new lesions. PFS rate was percentage of participants with PFS.
次要结局
- Overall Survival (OS)(From treatment initiation to death due to any cause or last day of contact, whichever occurred first (maximum follow-up of 47.1 months))
- OS Rate at Months 12 and 18(12- and 18-months post treatment initiation date (during maximum follow-up of 47.1 months))
- Number of Participants According to Different Treatments Received(From treatment initiation to end of follow-up (maximum follow-up of 47.1 months))
- Number of Participants With Different Drug Therapies(From treatment initiation to end of follow-up (maximum follow-up of 47.1 months))
- Best Overall Response(From treatment initiation until first documented PD or death or end of follow-up, whichever occurred first (maximum follow-up of 47.1 months))
- Duration of Response (DOR)(From first disease response until tumor progression (maximum follow-up of 47.1 months))
- Time to Progression (TTP)(From treatment initiation until tumor progression or end of follow-up whichever occurred first (maximum follow-up of 47.1 months))
- Time to Next Therapy (TTNT)(From last systemic 1 L therapy to start of new therapy (maximum follow-up of 47.1 months))
- Number of Participants With at Least 1 Dose Modification or Drug Discontinuation(From treatment initiation to end of follow-up (maximum follow-up of 47.1 months))
- Number of Participants Continuing Therapy After Dose Modification(From treatment initiation to end of follow-up (maximum follow-up of 47.1 months))
- Number of Participants With Discontinuation of One or Two Drugs(From treatment initiation to end of follow-up (maximum follow-up of 47.1 months))
- Number of Participants Continuing Therapy After Temporary/Permanent Discontinuation of Single Drugs(From treatment initiation to end of follow-up (maximum follow-up of 47.1 months))