Clinical trial NCT05534789: Treatment Patterns and Clinical Outcomes Among Patients With Advanced Renal Cell Carcinoma (aRCC) Receiving Systemic First-line (1st Line) Anti-cancer Treatment Under Daily Routine in Germany: Retrospective Medical Chart Review (RENALISTIC Study).
Official title: 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)
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Carcinoma, Renal Cell
Keywords: Real World Chart Review
Retrospective
Germany
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2022-09-10
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants who received first line treatment for advanced renal call carcinoma

Brief summary: 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


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

Primary outcomes:
measure: Progression Free Survival (PFS)
timeFrame: From treatment initiation date until PD, death or end of follow-up period whichever was earlier (maximum follow-up of 47.1 months)
measure: PFS Rate at Month 6
timeFrame: 6 months post treatment initiation date (during maximum follow-up of 47.1 months)
measure: PFS Rate at Month 9
timeFrame: 9 months post treatment initiation date (during maximum follow-up of 47.1 months)
measure: PFS Rate at Month 12
timeFrame: 12 months post treatment initiation date (during maximum follow-up of 47.1 months)
measure: PFS Rate at Month 18
timeFrame: 18 months post treatment initiation date (during maximum follow-up of 47.1 months)
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: From treatment initiation to death due to any cause or last day of contact, whichever occurred first (maximum follow-up of 47.1 months)
measure: OS Rate at Months 12 and 18
timeFrame: 12- and 18-months post treatment initiation date (during maximum follow-up of 47.1 months)
measure: Number of Participants According to Different Treatments Received
timeFrame: From treatment initiation to end of follow-up (maximum follow-up of 47.1 months)
measure: Number of Participants With Different Drug Therapies
timeFrame: From treatment initiation to end of follow-up (maximum follow-up of 47.1 months)
measure: Best Overall Response
timeFrame: From treatment initiation until first documented PD or death or end of follow-up, whichever occurred first (maximum follow-up of 47.1 months)
measure: Duration of Response (DOR)
timeFrame: From first disease response until tumor progression (maximum follow-up of 47.1 months)
measure: Time to Progression (TTP)
timeFrame: From treatment initiation until tumor progression or end of follow-up whichever occurred first (maximum follow-up of 47.1 months)
measure: Time to Next Therapy (TTNT)
timeFrame: From last systemic 1 L therapy to start of new therapy (maximum follow-up of 47.1 months)
measure: Number of Participants With at Least 1 Dose Modification or Drug Discontinuation
timeFrame: From treatment initiation to end of follow-up (maximum follow-up of 47.1 months)
measure: Number of Participants Continuing Therapy After Dose Modification
timeFrame: From treatment initiation to end of follow-up (maximum follow-up of 47.1 months)
measure: Number of Participants With Discontinuation of One or Two Drugs
timeFrame: From treatment initiation to end of follow-up (maximum follow-up of 47.1 months)
measure: Number of Participants Continuing Therapy After Temporary/Permanent Discontinuation of Single Drugs
timeFrame: From treatment initiation to end of follow-up (maximum follow-up of 47.1 months)
Other outcomes:
Locations:
city: New York
country: United States
facility: Pfizer New York
state: New York
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: