Metastatic Colorectal Cancer
Conditions
Keywords
Perfusion-computed tomography
Brief summary
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
Detailed description
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.
Interventions
DEVICEComputed tomography X-ray system
Contrast-enhanced computed tomography of liver metastases
Sponsors
Roche Pharma AG
Patrick Veit-Haibach
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years, male or female * Signed written informed consent * Patients with histologically confirmed diagnosis of colorectal cancer with hepatic metastases who are candidates for systemic treatment. * Confirmation of metastatic liver disease within one month prior to inclusion in one of the following radiological procedures: * Contrast-enhanced spiral computed tomography showing at least one liver nodule ≥ 20 mm in longest diameter according to RECIST 1.1 criteria * MR imaging of the liver with liver lesions suspicious for metastases * PET computed tomography (PET/CT) with liver lesions suspicious for metastases * Patient is eligible and designated for treatment with standard-of-care first-line bevacizumab-containing, fluoropyrimidine-based chemotherapy. * ECOG performance status ≤ 2 (see appendix)
Exclusion criteria
* Inability or unwillingness to comply with the participation requirements * History of untreated hyperthyreosis * History of intolerance of or allergy to iodine contrast media according to CTCAE V4.03 * Calculated creatinine clearance \< 45 ml/min * For fertile women: positive urine pregnancy test or lactation. * Known or suspected non-compliance, drug or alcohol abuse * Life expectancy of less than 3 months * Participation in another interventional trial with an investigational medicinal product (IMP) and within 30 days prior to screening
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| CTP as predictive marker for efficacy measured by progression-free survival | one year | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| CTP as predictive marker for efficacy measured by progression-free survival | one year | 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 |
| CTP as predictive marker for efficacy measured by overall survival | four years | Predictive power of decrease in tumor vasculature measured by CTP on the clinical outcome in bevacizumab-based chemotherapy measured by overall survival (OS) |
| Tumor vasculature at progression | one year | Tumor vasculature measured by blood flow, blood volume, mean transit time and permeability surface-area product in CTP at the time of confirmed progression |
| Subgroup analyses according to the RAS mutation status, BRAF mutation status and VEGF-A level | one year | 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) |
| Local and distant recurrences | one year | Rates of local and distant recurrences according to RECIST 1.1 criteria |
Countries
Switzerland
Outcome results
None listed