Overview

This trial is active, not recruiting.

Conditions colorectal cancer, liver metastases
Sponsor Andrew Kennedy
Collaborator Sirtex Medical
Start date December 2012
End date June 2013
Trial size 1000 participants
Trial identifier NCT01815879, MORE

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only
Time perspective retrospective
Arm
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

Primary Outcomes

Measure
Adverse events at day 0-90 post 90Y therapy using CTCae 3.0 criteria.
time frame: 3 months

Secondary Outcomes

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

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title Metastatic Colorectal Cancer Liver Metastases Outcomes After Resin 90Y Microsphere Radioembolization in the USA Evaluation Project
Principal investigator Andrew S Kennedy, MD, FACRO
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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2013.
Information provided to ClinicalTrials.gov by Sarah Cannon.