None listed
Conditions
Interventions
The study is a multi-centre phase I/II dose-escalation study that aims to assess the safety and efficacy of a single implantation of SIR-Spheres when used in combination with systemic chemotherapy with FOLFOX4. Toxicity will be assessed after 3 cycles of treatment, at which stage the oxaliplatin will be escalated to full dose and the patients will go on receive a maximum of 12 cycles of chemotherapy. (The duration of the treatment cycles varies as it is based on the doctor's discretion. Ideal
The study is a multi-centre phase I/II dose-escalation study that aims to assess the safety and efficacy of a single implantation of SIR-Spheres when used in combination with systemic chemotherapy with FOLFOX4. Toxicity will be assessed after 3 cycles of treatment, at which stage the oxaliplatin will be escalated to full dose and the patients will go on receive a maximum of 12 cycles of chemotherapy. (The duration of the treatment cycles varies as it is based on the doctor's discretion. Ideally the treatment cycles would be 1 week of treatment and then 1 week of rest.)
Sponsors
Sirtex Medical Limited
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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.
Outcome results
None listed