1. TREATMENT ARM B: Cycles 1–3: Cycles 4+: 5-FU continuous infusion
2400 mg/m²
SIR-Spheres
mBSA dosimetry
5-FU bolus
400 mg/m² LV
200 mg/m²
Cycles 1–3:
oxaliplatin
60 mg/m² D1
0 h
2 h
46 h
D3/4 Cycle 1 only
TREATMENT ARM B:
5-FU continuous infusion
2400 mg/m²
5-FU bolus
400 mg/m² LV
200 mg/m²
Cycles 4+:
oxaliplatin
85 mg/m² D1
0 h
2 h
46 h
Trial Design: Chemotherapy
5-FU and LV components of the chemotherapeutic regimen were administered as per the standard FOLFOX4 schedule. Oxaliplatin was administered at a reduced starting dose for the first 3 cycles. The treatment schema and initial dose level of oxaliplatin are shown.
Subject to a satisfactory adverse event profile, the oxaliplatin was escalated to the standard maintenance dose at the commencement of cycle 4.
Trial Design: Selective Internal Radiation Therapy (SIRT)
SIR-Spheres was integrated into the treatment schema by implanting the spheres on day 3 of the first cycle only. This is done to maximise the radiopotentiation effect.
Trial Design: Efficacy
Patients were given follow-up CT scans at 3 months, 6 months and a confirmatory scan 1 month later in the event positive results (complete response or partial response) were reported in either scan.
Patients were also monitored in order to assess time to disease progression and location of progression.
bevacizumab†
5–10 mg/kg
30–60 min
Cycles are repeated every 2 weeks until:
There is unacceptable toxicity.
Evidence of tumour progression at any site determined by CT/MRI scan, X-ray, ultrasound, or clinical examination.
The patient requests an end to treatment.
Complete surgical resection or ablation of primary and metastatic cancerous lesions.
Or dose-limiting peripheral neuropathy (chemotherapy must continue with the same doses and regimen of 5-FU/LV alone).