Phase 1/2 study of SIR-Spheres plus systemic chemotherapy with 5-fluorouracil, leucovorin and oxaliplatin in patients with liver metastases from colorectal carcinoma
A phase 1/2 study to test the safety and efficacy of a single implantation of SIR-Spheres plus systemic chemotherapy with FOLFOX4 in patients with liver metastases derived from colorectal carcinoma.
Sirtex Medical Limited
20 participants
Jul 1, 2002
Interventional
Conditions
Eligibility
Plain Language Summary
Simplified for easier understanding
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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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. Ideally the treatment cycles would be 1 week of treatment and then 1 week of rest.)
Locations(1)
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ACTRN12606000007538