N/A
Completed N=376
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 · Kidney Cancer
Source: ClinicalTrials.gov NCT05745142 ↗
Enrolled (actual)
376
Serious AEs
—
Results posted
Aug 2024
Primary outcomePrimary: Objective Response Rate (ORR) According to Disease Risk Group in IMDC — 57.5; 44.6; 24.0 Percentage of participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Objective Response Rate (ORR) According to Disease Risk Group in IMDC |
57.5; 44.6; 24.0 | — |
| PRIMARY Response Rates According to Disease Risk Group in IMDC |
3.0; 5.4; 4.0; 54.5; 39.2; 20.0 | — |
| PRIMARY ORR According to Disease Risk Group in MSKCC |
66.6; 44.1; 30 | — |
| PRIMARY Response Rates According to Disease Risk Group in MSKCC |
3.3; 2.9; 0.0; 63.3; 41.2; 30.0 | — |
| SECONDARY Overall Survival (OS) Rate According to Disease Risk Group in IMDC |
41.9; 31.2; 7.1 | — |
| SECONDARY Progression-Free Survival (PFS) According to Disease Risk Group in IMDC |
19.4; 13.14; 5.02 | — |
| SECONDARY OS According to Disease Risk Group in MSKCC |
52.2; 24.0; 4.9 | — |
| SECONDARY PFS According to Disease Risk Group in MSKCC |
NA; NA; NA | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT05745142). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.