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Clinical Trial Summary

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.


Clinical Trial Description

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 Design


Related Conditions & MeSH terms


NCT number NCT01895257
Study type Interventional
Source Universiteit Antwerpen
Contact Micheline Stempin
Phone +32474074584
Email clinicaltrials@bgdo.org
Status Recruiting
Phase Phase 3
Start date August 2013
Completion date December 2018

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