First line irinotecan dose escalation study

Interventions: This multi-centre dose escalation study is designed to assess the safety and efficacy of a single implant of SIR-Spheres when given in combination with the first line chemotherapy combination consisting of irinotecan, 5-fluorouracil and leucovorin. The chemotherapy will be administered on weeks 1 and 2 of a 3 week cycle and given for 3 cycles. The irinotecan will then be escalated to the standard dose and an additional 6 cycles of chemotherapy will be administered.
Primary outcome(s): Toxicity[Assessed up to 1 month after the conclusion of protocol chemotherapy];Response rate[Assessed up until the scan after the conclusion of protocol chemotherapy]
Study Design: Purpose: Treatment; Allocation: Non-randomised trial; Masking: Open (masking not used);Assignment: Single group;Type of endpoint: Safety/efficacy