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).

NCT05534789 | Terminated Results

• 1 other identifier: A4061099
• Study Type: observational
• Target: 106
• Locations: 1 country
• Sites: 1

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

Conditions

Carcinoma, Renal Cell

Keywords

Real World Chart Review; Retrospective; Germany

Outcome Measures

Primary Outcomes (5)

• Progression Free Survival (PFS)

  PFS was defined as time from treatment initiation of systemic 1-L therapy start date to documented date of tumor progression or date of death. Disease progression (PD) was defined as greater than equal to (\>=) 20% increase in sum of diameters of the target lesions taking as reference the smallest sum on study (this included the baseline sum if that was the smallest on study) or unequivocal progression in non-target lesions or appearance of 1 or more new lesions. Analysis was performed by Kaplan-Meier method.

  From treatment initiation date until PD, death or end of follow-up period whichever was earlier (maximum follow-up of 47.1 months)

• PFS Rate at Month 6

  PFS was defined as time from treatment initiation of systemic 1-L therapy start date to documented date of tumor progression or date of death. Disease progression (PD) was defined as greater than equal to (\>=) 20% increase in sum of diameters of the target lesions taking as reference the smallest sum on study (this included the baseline sum if that was the smallest on study) or unequivocal progression in non-target lesions or appearance of 1 or more new lesions. PFS rate was percentage of participants with PFS.

  6 months post treatment initiation date (during maximum follow-up of 47.1 months)

• PFS Rate at Month 9

  PFS was defined as time from treatment initiation of systemic 1-L therapy start date to documented date of tumor progression or date of death. Disease progression (PD) was defined as greater than equal to (\>=) 20% increase in sum of diameters of the target lesions taking as reference the smallest sum on study (this included the baseline sum if that was the smallest on study) or unequivocal progression in non-target lesions or appearance of 1 or more new lesions. PFS rate was percentage of participants with PFS.

  9 months post treatment initiation date (during maximum follow-up of 47.1 months)

• PFS Rate at Month 12

  PFS was defined as time from treatment initiation of systemic 1-L therapy start date to documented date of tumor progression or date of death. Disease progression (PD) was defined as greater than equal to (\>=) 20% increase in sum of diameters of the target lesions taking as reference the smallest sum on study (this included the baseline sum if that was the smallest on study) or unequivocal progression in non-target lesions or appearance of 1 or more new lesions. PFS rate was percentage of participants with PFS.

  12 months post treatment initiation date (during maximum follow-up of 47.1 months)

• PFS Rate at Month 18

  PFS was defined as time from treatment initiation of systemic 1-L therapy start date to documented date of tumor progression or date of death. Disease progression (PD) was defined as greater than equal to (\>=) 20% increase in sum of diameters of the target lesions taking as reference the smallest sum on study (this included the baseline sum if that was the smallest on study) or unequivocal progression in non-target lesions or appearance of 1 or more new lesions. PFS rate was percentage of participants with PFS.

  18 months post treatment initiation date (during maximum follow-up of 47.1 months)

Secondary Outcomes (12)

• Overall Survival (OS)

  From treatment initiation to death due to any cause or last day of contact, whichever occurred first (maximum follow-up of 47.1 months)

• OS Rate at Months 12 and 18

  12- and 18-months post treatment initiation date (during maximum follow-up of 47.1 months)

• Number of Participants According to Different Treatments Received

  From treatment initiation to end of follow-up (maximum follow-up of 47.1 months)

• Number of Participants With Different Drug Therapies

  From treatment initiation to end of follow-up (maximum follow-up of 47.1 months)

• Best Overall Response

  From treatment initiation until first documented PD or death or end of follow-up, whichever occurred first (maximum follow-up of 47.1 months)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants who received first line treatment for advanced renal call carcinoma

You may qualify if:

• 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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer New York

New York, New York, 10017, United States

Location

Related Links

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

MeSH Terms

Conditions

Carcinoma, Renal Cell

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2022
• First Posted: September 10, 2022
• Study Start: October 15, 2022
• Primary Completion: December 13, 2023
• Study Completion: December 13, 2023
• Last Updated: January 20, 2025
• Results First Posted: January 20, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)