The primary objective of this study is to investigate the anti-angiogenic effect of bevacizumab measured by CTP as a predictive marker for efficacy measured by progression-free survival (PFS) in mCRC patients under first-line bevacizumab-containing, fluoropyrimidine-based chemotherapy
So far, CTP has provided non-invasive imaging of tumor biological response to anti-angiogenic and vascular targeting agents in a number of clinical trials with increasing clinical application. CTP can be examined with a variety of commercially available CE-certified CT scanners and imaging post-processing is possible with commercially available CE-certified software from different vendors, too. In several studies, anti-angiogenic effects have been detected with CTP but further evidence for its clinical validation has to be proven in clinical trials. Changes in tumor vasculature measured by CTP will be correlated to the clinical efficacy parameters progression-free survival, overall survival and response rate, thus identifying a group of patients who profit most from the anti-angiogenic treatment.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
SINGLE
Enrollment
50
Contrast-enhanced computed tomography of liver metastases
Luzerner Kantonsspital
Lucerne, Canton of Lucerne, Switzerland
Kantonsspital St. Gallen
Sankt Gallen, Canton of St. Gallen, Switzerland
Kantonsspital Winterthur
Winterthur, Canton of Zurich, Switzerland
Universitätsspital Zürich
Zurich, Canton of Zurich, Switzerland
CTP as predictive marker for efficacy measured by progression-free survival
Predictive power of decrease in tumor vasculature on the clinical outcome in bevacizumab-based chemotherapy measured by progression-free survival (PFS). Decrease in tumor vasculature is measured by blood flow in CTP 3 compared to CTP 1 (baseline)
Time frame: one year
CTP as predictive marker for efficacy measured by progression-free survival
Predictive power of decrease in tumor vasculature on the clinical outcome in bevacizumab-based chemotherapy measured by progression-free survival (PFS). Decrease in tumor vasculature is measured by blood flow, blood volume, mean transit time and permeability surface-area product in CTP
Time frame: one year
CTP as predictive marker for efficacy measured by overall survival
Predictive power of decrease in tumor vasculature measured by CTP on the clinical outcome in bevacizumab-based chemotherapy measured by overall survival (OS)
Time frame: four years
Tumor vasculature at progression
Tumor vasculature measured by blood flow, blood volume, mean transit time and permeability surface-area product in CTP at the time of confirmed progression
Time frame: one year
Subgroup analyses according to the RAS mutation status, BRAF mutation status and VEGF-A level
Predictive power of RAS-mutation status, BRAF-mutation status and VEGF-A level on the clinical outcome in bevacizumab-based chemotherapy measured by progression-free survival (PFS)
Time frame: one year
Local and distant recurrences
Rates of local and distant recurrences according to RECIST 1.1 criteria
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Kantonsspital Graubünden
Chur, Kanton Graubünden, Switzerland
Time frame: one year