Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 6:31 PM
Ignite Modification Date:
2025-12-24 @ 6:31 PM
NCT ID:
NCT01895257
Brief 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.
Detailed 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:
NCT01895257
Study Brief:
Protocol Section:
NCT01895257