Clinical trial · Interventional
Comparing Hepatic Intra-arterial Injection of Yttrium-90 Microspheres Versus Fluorouracil (5FU) in Colorectal Cancer Metastatic to the Liver Only
Comparison Hepatic Intra-arterial Injection of Yttrium-90 Versus 5FU in Colorectal Cancer Metastatic to the Liver Only
NCT00199173CI-TRIAL-00004458completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Neoplasm | Colorectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Secondary Malignant Neoplasm of Liver | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SIR Spheres intra-arterial hepatic | Device | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.