Clinical trial NCT02511756: Visualization of Anti-angiogenic Effects With Perfusion Computed Tomography (CTP)
Official title: Visualization of Anti-angiogenic Effects With Perfusion Computed Tomography (CTP) in mCRC Patients Treated With First-line Bevacizumab
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Metastatic Colorectal Cancer
Keywords: Perfusion-computed tomography
Lead sponsor: University of Zurich
Sponsor class: OTHER
Collaborators: name: Roche Pharma AG
First posted: 2015-07-30
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: CTP as predictive marker for efficacy measured by progression-free survival
timeFrame: one year
Secondary outcomes:
measure: CTP as predictive marker for efficacy measured by progression-free survival
timeFrame: one year
measure: CTP as predictive marker for efficacy measured by overall survival
timeFrame: four years
measure: Tumor vasculature at progression
timeFrame: one year
measure: Subgroup analyses according to the RAS mutation status, BRAF mutation status and VEGF-A level
timeFrame: one year
measure: Local and distant recurrences
timeFrame: one year
Other outcomes:
Locations:
city: Chur
country: Switzerland
facility: Kantonsspital Graubünden
state: GR
city: Luzern
country: Switzerland
facility: Luzerner Kantonsspital
state: LU
city: St. Gallen
country: Switzerland
facility: Kantonsspital St. Gallen
state: SG
city: Winterthur
country: Switzerland
facility: Kantonsspital Winterthur
state: ZH
city: Zürich
country: Switzerland
facility: Universitätsspital Zürich
state: ZH
Study officials:
affiliation: University Hospital Zurich, Diagnostic and Interventional Radiology
name: Patrick Veit-Haibach, MD
role: PRINCIPAL_INVESTIGATOR
References: