Clinical Outcomes for Patients With Renal Cell Carcinoma Who Received First-Line Sunitinib

NCT ID: NCT04076787

Last Updated: 2023-04-06

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1769 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-09-01

Study Completion Date

2018-09-02

Brief Summary

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This is a retrospective, longitudinal cohort study that assessed clinical outcomes of patients with metastatic renal cell carcinoma (mRCC) who received sunitinib as first-line treatment.

Detailed Description

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Clear cell mRCC patients who initiated sunitinib as first-line treatment between 2010 and 2018 were identified from the IMDC database. Patients were classified as favorable, intermediate, or poor prognostic risk group according to IMDC criteria. Overall survival, time to treatment discontinuation, and physician-assessed tumor response were evaluated.

Conditions

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Metastatic Renal Cell Carcinoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Favorable IMDC risk group

The cohort of mRCC patients receiving sunitinib as first-line treatment and classified as favorable IMDC risk group for having 0 individual risk factor

Sunitinib

Intervention Type DRUG

patients who received sunitinib as first line therapy for mRCC

Intermediate IMDC risk group

The cohort of mRCC patients receiving sunitinib as first-line treatment and classified as intermediate IMDC risk group for having 1 or 2 individual risk factors

Sunitinib

Intervention Type DRUG

patients who received sunitinib as first line therapy for mRCC

Poor IMDC risk group

The cohort of mRCC patients receiving sunitinib as first-line treatment and classified as poor IMDC risk group for having 3 or more individual risk factors

Sunitinib

Intervention Type DRUG

patients who received sunitinib as first line therapy for mRCC

Interventions

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Sunitinib

patients who received sunitinib as first line therapy for mRCC

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Diagnosed with mRCC
* Initiated treatment post mRCC diagnosis and received sunitinib as first-line therapy
* Age 18 years or over at the time of mRCC diagnosis
* Actively treated at an IMDC clinical center

Exclusion Criteria

* Initiated first line sunitinib treatment before 2010
* Had non-clear cell mRCC
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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International Metastatic Renal Cell Carcinoma Database Consortium (IMDC)

OTHER

Sponsor Role collaborator

Analysis Group, Inc.

INDUSTRY

Sponsor Role collaborator

Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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University of Calgary

Calgary, Alberta, Canada

Site Status

Countries

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Canada

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

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https://pmiform.com/clinical-trial-info-request?StudyID=A6181229

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Other Identifiers

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A6181229

Identifier Type: -

Identifier Source: org_study_id

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