A Retrospective Registry Based Study for Evaluating Treatment Response in Patients Targeted Treated With Metastatic Renal Cell Carcinoma (mRCC) With Sunitinib in First-line Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 376
- 试验地点
- 1
- 主要终点
- Objective Response Rate (ORR) According to Disease Risk Group in IMDC
研究概览
简要总结
The purpose of this study is to understand how patients with mRCC respond to the study medicine (called sunitinib) when they receive it as the first line of treatment after finding out the cause for the disease.
This study will look into how different and how well groups of people with high chances of developing the disease respond to the study medicine.
All data for this study will be anonymously extracted from data already entered in RCC Registry which is owned by Turkish Oncology Group Association (TOGD).
This study will pull out records from the Registry between 01-Mar-2019 and 30-Oct-2022 that belongs to people:
- who are Turkish citizens
- who are older than 18 years
- who were found out to have mRCC
- who received sunitinib as the first line treatment after finding out the cause for the disease
This study will look at the responses, experiences and how long the patients use the study medicine sunitinib.
详细描述
This study is designed as a local, non-interventional, retrospective, registry-based study to observe treatment response in patients with metastatic Renal Cell Carcinoma with Sunitinib First-Line Therapy based on data extracted and analyzed from the RCC Registry.
The annual disease burden in contributing centers to RCC Registry is approximately 100 patient/center, the treatment of an average of 250 patients per year is continued in the centers. Therefore, it is estimated that information of approximately 400 eligible patients who were registered in RCC Registry from 2019 to 2022 will be included in the analysis.
RCC Registry will be used as the sole data source for this study. For this purpose, no Case Report Forms (CRFs) or Data Collection Tools (DCTs) will be utilized, but the RCC Registry database will be used directly. Eligible patients' data will be anonymized and extracted for analysis by the registry owner, for this study.
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
- •Being a Turkish citizen.
- •Being older than 18 years-old.
- •Being clinically diagnosed with mRCC and treated.
- •Being treated with Sunitinib in first line
排除标准
- •Patients whose treatment was initiated but excluded from follow-up for any reason.
研究组 & 干预措施
metastatic Renal Cell Carcinoma patients
metastatic Renal Cell Carcinoma patients with clear cell histology.
干预措施: Sunitinib (Drug)
结局指标
主要结局
Objective Response Rate (ORR) According to Disease Risk Group in IMDC
时间窗: From initiation of sunitinib treatment (retrospective data) till PR and CR or death or progression (up to 30-Oct-2022, cut-off for data registry); approximate follow-up duration of 73 months [from data extracted from registry database]
ORR: percentage of participants with partial response (PR) and complete response (CR). As per response evaluation criteria in solid tumors (RECIST)1.1 criteria: CR = disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Disappearance of all non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (\<10 mm short axis); PR = at least 30% decrease in sum of diameters of target lesions taking as reference baseline sum diameters. IMDC assessed as favorable (0), intermediate (1-2) or poor (\>=3) based on number of criteria present (KPS \<80%; time from diagnosis to start of systemic therapy \<1 year; corrected serum calcium \[Ca\]; neutrophils and platelets \>ULN; hemoglobin \[hg\] \<LLN).
Response Rates According to Disease Risk Group in IMDC
时间窗: From initiation of sunitinib treatment (retrospective data) till PR/ CR/ SD/ death or progression (up to 30-Oct-2022, cut-off for data registry); approximate follow-up duration of 73 months [from data extracted from registry database]
RECIST1.1- CR: disappearance of all lesions \& normalization of tumor marker level. Any pathological lymph nodes must have reduction in short axis to \<10 mm. All lymph nodes must be non-pathological in size (\<10 mm short axis); PR: at least 30% decrease in sum of diameters of target lesions taking as reference baseline sum diameters; progressive disease (PD): at least 20% increase in sum of longest dimensions of target lesions, reference to the smallest sum of the longest dimensions recorded since treatment started, or appearance of 1 or more new lesions or increase of at least 5 mm in addition to the relative increase of 20%; stable disease (SD): neither shrinkage for CR/PR nor increase for PD taking as reference smallest sum of longest diameters since treatment start. IMDC: favorable (0), intermediate (1-2) or poor (\>=3) based on number of criteria present (KPS \<80%; time from diagnosis to start of systemic therapy \<1 year; corrected serum Ca\]; neutrophils \& platelets \>ULN; hg \<LLN).
ORR According to Disease Risk Group in MSKCC
时间窗: From initiation of sunitinib treatment (retrospective data) till PR and CR or death or progression (up to 30-Oct-2022, cut-off for data registry); approximate follow-up duration of 73 months [from data extracted from registry database]
ORR: percentage of participants with PR and CR. As per RECIST 1.1 criteria: CR = disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Disappearance of all non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (\<10 mm short axis); PR = at least 30% decrease in sum of diameters of target lesions taking as reference baseline sum diameters. MSKCC assessed as favorable (0), intermediate (1-2) or poor (\>=3) based on number of criteria present \[KPS \<80%, time from diagnosis to start of systemic therapy \<12 months, lactate dehydrogenase \>1.5\*ULN, hemoglobin \<LLN, serum calcium \>10 mg/dL\].
Response Rates According to Disease Risk Group in MSKCC
时间窗: From initiation of sunitinib treatment (retrospective data) till PR/ CR/ SD/ death or progression (up to 30-Oct-2022, cut-off for data registry); approximate follow-up duration of 73 months [from data extracted from registry database]
RECIST1.1- CR: disappearance of all lesions and normalization of tumor marker level. Any pathological lymph nodes must have reduction in short axis to \<10 mm. All lymph nodes must be non-pathological in size (\<10 mm short axis); PR: at least 30% decrease in sum of diameters of target lesions taking as reference baseline sum diameters; PD: at least 20% increase in sum of longest dimensions of target lesions, reference to the smallest sum of the longest dimensions recorded since treatment started, or the appearance of 1 or more new lesions or increase of at least 5 mm in addition to the relative increase of 20%; SD: neither shrinkage for CR/PR nor increase for PD taking as reference smallest sum of longest diameters since treatment start. MSKCC assessed as favourable (0), intermediate (1-2) or poor (\>=3) based on number of criteria present \[KPS \<80%, time from diagnosis to start of systemic therapy \<12 months, lactate dehydrogenase \>1.5\*ULN, hemoglobin \<LLN, serum calcium \>10 mg/dL\].
次要结局
- OS According to Disease Risk Group in MSKCC(From initiation of sunitinib treatment (retrospective data) till death or censored date (up to 30-Oct-2022, cut-off for data registry); approximate follow-up duration of 73 months [from data extracted from registry database])
- Progression-Free Survival (PFS) According to Disease Risk Group in IMDC(From initiation of sunitinib treatment (retrospective data) till progression end of treatment date or date of death (up to 30-Oct-2022, cut-off for data registry); approximate follow-up duration of 73 months [from data extracted from registry database])
- PFS According to Disease Risk Group in MSKCC(From initiation of sunitinib treatment (retrospective data) till progression end of treatment date or date of death (up to 30-Oct-2022, cut-off for data registry); approximate follow-up duration of 73 months [from data extracted from registry database])
- Overall Survival (OS) Rate According to Disease Risk Group in IMDC(From initiation of sunitinib treatment (retrospective data) till death or censored date (up to 30-Oct-2022, cut-off for data registry); approximate follow-up duration of 73 months [from data extracted from registry database])