Phase 1/2 study of SIR-Spheres plus systemic chemotherapy with 5-fluorouracil, leucovorin and oxaliplatin in patients with liver metastases from colorectal carcinoma

Phase 1

Active, not recruiting

• Conditions: nresectable liver metastases from colorectal carcinoma; Unresectable liver metastases from colorectal carcinoma; Cancer - Bowel - Back passage (rectum) or large bowel (colon); Cancer - Liver

• Registration Number: ACTRN12606000007538
• Lead Sponsor: Sirtex Medical Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-01-04
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Histologically confirmed adenocarcinoma of the colon or rectum. CT evidence of malignant metastases in the liver. Liver metastases not treatable by some other form of local ablation. Prior treatment for metastatic CRC is not allowedAdequate hepatic, renal and haematological functionWHO performance status 0-2Willing and able to provide written informed consent.

Exclusion Criteria

Pregnant or breast feedingEvidence of ascites, cirrhosis or portal hypertensionCNS metastases Previous radiotherapy to the upper abdomenNon-malignant disease that would render the patient ineligible for treatmentEquivocal, immeasurable or unevaluable metastases in the liverHepatic arterial anatomy that would prevent administration of SIR-Spheres>20% arteriovenous lungshuntingDLT associated with previous 5FU chemotherapy.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Toxicity[Assessed using standard UICC criteria which will be assessed after patients have completed 12 cycles of chemotherapy.]