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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01815879

Acronym

Enrollment

1000

Registered

2013-03-21

Start date

2012-12-31

Completion date

Unknown

Last updated

2013-03-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer, Liver Metastases

Keywords

metastatic colorectal cancer, liver metastases, 90Y resin microsphere radioembolization, retrospective data analysis

Brief summary

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

United States

Outcome results