Metastatic Colorectal Cancer Liver Metastases Outcomes After Resin 90Y Microsphere Radioembolization in the USA Evaluation Project

NCT ID: NCT01815879

Last Updated: 2013-03-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-12-31

Brief Summary

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Investigator initiated multi-institutional retrospective review of clinical and radiographic outcomes after 90Y resin microsphere radioembolization for metastatic colorectal liver metastases in the USA. The target is for at least 1,000 evaluable patients with 12+ weeks follow up.

Detailed Description

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Investigator initiated multi-institutional retrospective review of clinical and radiographic outcomes after 90Y resin microsphere radioembolization for metastatic colorectal liver metastases in the USA. The target is for at least 1,000 evaluable patients with 12+ weeks follow up. Objectives:

Independent data collection and reporting of pre treatment and 12 week post treatment clinical, radiographic and radiation parameters and outcomes in patients treated in the USA from 2002-2010. Data beyond 12 weeks will be collected and highly desirable, however as a minimum all patients will have 12 week follow up.

Conditions

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Colorectal Cancer Liver Metastases

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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Control Group

Retrospective review of clinical data on at least 1,000 evaluable US patients with 12+weeks follow up that were treated with 90Y resin microsphere radioembolization for metastatic colorectal liver metastases

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Patients who received 90Y resin microsphere radioembolization for metastatic colorectal cancer with liver metastases between November 2010 and March 2011 in the USA. Patients must have at least 12 weeks of follow up.

Exclusion Criteria

* Patients who received glass 90Y microsphere radioembolization for metastatic colorectal liver metastases.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sirtex Medical

INDUSTRY

Sponsor Role collaborator

Andrew Kennedy

INDUSTRY

Sponsor Role lead

Responsible Party

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Andrew Kennedy

Principal Investigator and Sponsor-Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Andrew S Kennedy, MD, FACRO

Role: PRINCIPAL_INVESTIGATOR

SCRI Development Innovations, LLC

Locations

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Contact Sarah Cannon

Nashville, Tennessee, United States

Site Status

Countries

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United States

Other Identifiers

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MORE

Identifier Type: -

Identifier Source: org_study_id

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