NCT00199173

Brief Summary

This is a Phase III trial comparing hepatic intra-arterial injection of Yttrium-90 microspheres (selective internal radiation \[SIR\] spheres) versus infusional intravenous (IV) 5FU in colorectal cancer metastatic to the liver only and refractory to standard IV chemotherapy.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 13, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
Last Updated

February 24, 2011

Status Verified

February 1, 2011

First QC Date

September 13, 2005

Last Update Submit

February 23, 2011

Conditions

Colorectal NeoplasmSecondary Malignant Neoplasm of Liver

Keywords

colorectal cancerliver metastasisintraarterial hepatic injectionyttrium loaded microspherescolorectal neoplasm metastatic to the liver

Interventions

SIR Spheres intra-arterial hepaticDEVICE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically proven colorectal adenocarcinoma, metastatic to the liver only.
  • Failure of prior chemotherapy for advanced colorectal cancer.
  • Adequate laboratory values of hematologic, renal and liver function
  • World Health Organization (WHO) performance status (PS) \<= 2
  • Written consent

You may not qualify if:

  • Pregnant or lactating patients
  • Other tumor type than adenocarcinoma (leiomyosarcoma; lymphoma).
  • Patients with cirrhosis or other chronic liver disease
  • Thrombosis of the hepatic main artery of the portal vein
  • Lung shunting \> 20% as determined by nuclear medicine breakthrough scan
  • Patients with serum bilirubin \> 1.0 x upper limit of normal (ULN) or with AST and/or ALT and/or alkaline phosphatase \> 5 x ULN
  • Patients with concurrent or within 4 week period administration of any other experimental drugs.
  • Other serious illness or medical conditions.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jules Bordet Institute

Brussels, 1000, Belgium

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Alain Hendlisz, MD

    Jules Bordet Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 20, 2005

Primary Completion

January 1, 2010

Study Completion

January 1, 2010

Last Updated

February 24, 2011

Record last verified: 2011-02

Locations

BE(1)