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

Colorectal Cancer Clinical Trial

— MORE  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01815879
• Other study ID #: MORE
• Status: Active, not recruiting
• Phase: N/A
• First received: December 18, 2012
• Last updated: March 20, 2013
• Start date: December 2012

Study information

• Verified date: March 2013
• Source: Sarah Cannon
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1000
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms
• Liver Metastases
• Liver Neoplasms
• Neoplasm Metastasis

Locations

Country	Name	City	State
United States	Contact Sarah Cannon	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Andrew Kennedy	Sirtex Medical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse events at day 0-90 post 90Y therapy using CTCae 3.0 criteria.	Multiple systems monitored for side effects possibly related to liver radiotherapy.	3 months	No
Secondary	Radiographic response rate at 90 days (+/- 45 days) from treatment day, compared to pretreatment scans.	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.	3 months	No