The investigators propose to conduct a randomised phase III trial evaluating a maintenance strategy comparing hepatic arterial injection of Yttrium-90 resin microspheres plus continuing simplified chemotherapy with/without targeted therapy versus continuing simplified chemotherapy with/without targeted therapy alone for patient with dominant or exclusive and unresectable liver mCRC controlled after 3-6 months of chemotherapy induction.
The aim of the study is to investigate whether an intensified maintenance treatment of SIRT + simplified maintenance chemotherapy has a benefit in terms of time to progression (TTP) compared to simplified chemotherapy maintenance alone, in patients with stable disease after 3-6 months induction therapy. We would like to demonstrate the feasibility and safety of this approach and to investigate if this strategy has the potential to increase the outcome of the patient. Primary end-point: \- Time to first progression (TTP1 overall) Secondary end-points: * Time to global progression (TTP1 + TTP2), Time to second progression (TTP2), TTP1 liver only * Progression Free Survival (PFS) * Overall Survival (OS) * Safety * Ro resection rate * Quality of Life Exploratory analysis: \- Prediction and evaluation of SIR-spheres treatment response (only for Belgian centres)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
162
Patients randomised to receive the combination of SIR-Spheres microspheres plus systemic chemotherapy LV5FU2 need to be assessed in order to determine their suitability for SIRT. 1. Hepatic Angiogram 2. Liver-Lung Break-Through Nuclear Scan
Systemic chemotherapy with modified LV5FU2 will be administered according to the following regimen. Cycle 1 onwards: Day 1 Hour 0: Leucovorin L (levoleucovorin) 200 mg/m2 (or folinic acid 400 mg/m²) in 250 ml glucose 5%, 2-hour IV infusion Hour + 2: 5-FU bolus 400 mg/m2, IV bolus Hour + 2: 5-FU continuous infusion 2400 mg/m2, 46-hour cont. IV infusion Day 14 End of cycle. To be repeated every 14 days until evidence of treatment failure.
University of Antwerp
Edegem, Antwerp, Belgium
RECRUITINGASZ Aalst
Aalst, Belgium
ACTIVE_NOT_RECRUITINGInstitut Jules Bordet
Brussels, Belgium
Time to progression (TTP1 overall)
Time to first progression (TTP1 overall)
Time frame: Up to 36 months
Time to global progression (TTP1 + TTP2)
\- Time to global progression (TTP1 + TTP2), Time to second progression (TTP2), TTP1 liver only
Time frame: Up to 42 months
PFS
Progression free survival
Time frame: Up to 42 months
Safety
Time frame: Up to 42 months
R0 resection rate
Time frame: Up to 42 months
Quality of life
Using * EORTC QLQ C30 * EQ-5D
Time frame: Up to 42 months
Overall Survival (OS)
Time frame: Up to 42 months
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CUB Hôpital Erasme
Brussels, Belgium
ACTIVE_NOT_RECRUITINGUniversity of St-Luc
Brussels, Belgium
RECRUITINGGrand Hôpital de Charleroi
Charleroi, Belgium
RECRUITINGZOL Genk
Genk, Belgium
RECRUITINGAZ St-Lucas Gent
Ghent, Belgium
NOT_YET_RECRUITINGAZ Groeninge
Kortrijk, Belgium
RECRUITINGCHU de Liège
Liège, Belgium
RECRUITING