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Clinical Trials/NCT01815879
NCT01815879
Unknown
Not Applicable

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

Andrew Kennedy1 site in 1 country1,000 target enrollmentDecember 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Colorectal Cancer
Sponsor
Andrew Kennedy
Enrollment
1000
Locations
1
Primary Endpoint
Adverse events at day 0-90 post 90Y therapy using CTCae 3.0 criteria.
Last Updated
13 years ago

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
December 2012
End Date
June 2013
Last Updated
13 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Andrew Kennedy
Responsible Party
Sponsor Investigator
Principal Investigator

Andrew Kennedy

Principal Investigator and Sponsor-Investigator

Sarah Cannon

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Adverse events at day 0-90 post 90Y therapy using CTCae 3.0 criteria.

Time Frame: 3 months

Multiple systems monitored for side effects possibly related to liver radiotherapy.

Secondary Outcomes

  • Radiographic response rate at 90 days (+/- 45 days) from treatment day, compared to pretreatment scans.(3 months)

Study Sites (1)

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