Colorectal Neoplasm, Secondary Malignant Neoplasm of Liver
Conditions
Keywords
colorectal cancer, liver metastasis, intraarterial hepatic injection, yttrium loaded microspheres, colorectal neoplasm metastatic to the liver
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.
Interventions
DEVICESIR Spheres intra-arterial hepatic
Sponsors
University Hospital, Ghent
Jules Bordet Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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.
Countries
Belgium
Outcome results
None listed