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.

Carcinoma, Renal Cell Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05745142
• Other study ID #: A6181235
• Status: Completed
• Start date: February 23, 2023
• Est. completion date: February 23, 2023

Study information

• Verified date: April 2023
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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:

• 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 376
• Est. completion date: February 23, 2023
• Est. primary completion date: February 23, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Being a Turkish citizen.

• Being older than 18 years-old.

• Being clinically diagnosed with mRCC and treated.

• Being treated with Sunitinib in first line

Exclusion Criteria:

• Patients whose treatment was initiated but excluded from follow-up for any reason.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Renal Cell
• Clear-cell Metastatic Renal Cell Carcinoma

Intervention

Drug:
• Sunitinib
as provided in real world practice

Locations

Country	Name	City	State
Turkey	Pfizer	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival (OS) Rate	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.	01-Mar-2019 to 30-Oct-2022
Primary	Progression-Free Survival (PFS)	The period from study entry until disease progression, death or date of last contact.	01-Mar-2019 to 30-Oct-2022
Primary	Objective Response Rate - Percentage of Participants With Objective Response	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.	01-Mar-2019 to 30-Oct-2022
Secondary	Overall Survival (OS) Rate - for sunitinib regimen exchanged patients	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.	01-Mar-2019 to 30-Oct-2022
Secondary	Progression-Free Survival (PFS) - for sunitinib regimen exchanged patients	The period from study entry until disease progression, death or date of last contact for sunitinib regimen exchange patients.	01-Mar-2019 to 30-Oct-2022
Secondary	Objective Response Rate - Percentage of Participants With Objective Response - for sunitinib regimen exchanged patients	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	01-Mar-2019 to 30-Oct-2022

External Links

•   To obtain contact information for a study center near you, click here.