A Study to go Back Into Records and Observe How People With Metastatic Renal Cell Carcinoma (mRCC) Who Received a Medicine Called Sunitinib Responded to This Medicine.
Study Details
Study Description
Brief Summary
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:
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who are Turkish citizens
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who are older than 18 years
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who were found out to have mRCC
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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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| metastatic Renal Cell Carcinoma patients metastatic Renal Cell Carcinoma patients with clear cell histology. |
Drug: Sunitinib
as provided in real world practice
|
Outcome Measures
Primary Outcome Measures
- Overall Survival (OS) Rate [01-Mar-2019 to 30-Oct-2022]
OS will be based on Kaplan-Meier method. Survival is defined as the time period from the date of first dose of study drug to the date of death, censored at the participant's last contact date. Percent of participants with OS were estimated.
- Progression-Free Survival (PFS) [01-Mar-2019 to 30-Oct-2022]
The period from study entry until disease progression, death or date of last contact.
- Objective Response Rate - Percentage of Participants With Objective Response [01-Mar-2019 to 30-Oct-2022]
Percentage of participants with objective response based assessment of complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR is defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis <10 mm). No new lesions. PR is defined as >=30% decrease under baseline of the sum of diameters of all target lesions. The short axis will be used in the sum for target nodes, while the longest diameter will be used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions.
Secondary Outcome Measures
- Overall Survival (OS) Rate - for sunitinib regimen exchanged patients [01-Mar-2019 to 30-Oct-2022]
OS will be based on Kaplan-Meier method. Survival is defined as the time period from the date of first dose of study drug to the date of death, censored at the participant's last contact date. Percent of participants of sunitinib regimen exchange with OS will be estimated.
- Progression-Free Survival (PFS) - for sunitinib regimen exchanged patients [01-Mar-2019 to 30-Oct-2022]
The period from study entry until disease progression, death or date of last contact for sunitinib regimen exchange patients.
- Objective Response Rate - Percentage of Participants With Objective Response - for sunitinib regimen exchanged patients [01-Mar-2019 to 30-Oct-2022]
Percentage of participants, whose sunitinib regimen exchanged, with objective response based assessment of complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR is defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis <10 mm). No new lesions. PR is defined as >=30% decrease under baseline of the sum of diameters of all target lesions. The short axis will be used in the sum for target nodes, while the longest diameter will be used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions
Eligibility Criteria
Criteria
Inclusion Criteria:
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Being a Turkish citizen.
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Being older than 18 years-old.
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Being clinically diagnosed with mRCC and treated.
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Being treated with Sunitinib in first line
Exclusion Criteria:
- Patients whose treatment was initiated but excluded from follow-up for any reason.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Pfizer | Istanbul | Turkey | 34394 |
Sponsors and Collaborators
- Pfizer
Investigators
- Study Director: Pfizer CT.gov Call Center, Pfizer
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- A6181235