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

• Conditions: Colorectal Cancer; Liver Metastases

• Registration Number: NCT01815879
• Lead Sponsor: Andrew Kennedy

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.

Study Timeline

• Study Start: 2012-12
• Study First Submitted: 2012-12-18
• Status Verified: 2013-03
• Study First Submitted QC: 2013-03-20
• Last Update Submitted: 2013-03-20
• Study First Posted: 2013-03-21
• Last Update Posted: 2013-03-21
• Primary Completion: 2013-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Adverse events at day 0-90 post 90Y therapy using CTCae 3.0 criteria.	3 months	Multiple systems monitored for side effects possibly related to liver radiotherapy.

Secondary Outcome Measures

Name	Time	Method
Radiographic response rate at 90 days (+/- 45 days) from treatment day, compared to pretreatment scans.	3 months	Pretreatment planning scans (-45 to -1 day) compared to post radiotherapy scans of the liver, PET/CT not recommended, prefer MRI with Gd or CT with contrast, 3 phase, with rescanning in similar fashion at day 90 post treatment.

Trial Locations

Locations (1)

Contact Sarah Cannon; 🇺🇸 Nashville, Tennessee, United States