Visualization of Anti-angiogenic Effects With Perfusion Computed Tomography (CTP)

Metastatic Colorectal Cancer Clinical Trial

— AVA-CTP  

Official title:

Visualization of Anti-angiogenic Effects With Perfusion Computed Tomography (CTP) in mCRC Patients Treated With First-line Bevacizumab

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02511756
• Other study ID #: KEK-ZH-Nr. 2015-0084
• Status: Terminated
• Phase: N/A
• First received: April 29, 2015
• Last updated: December 15, 2016
• Start date: July 2015
• Est. completion date: April 2017

Study information

• Verified date: December 2016
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 50
• Est. completion date: April 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Metastatic Colorectal Cancer

Intervention

Device:
• Computed tomography X-ray system
Contrast-enhanced computed tomography of liver metastases

Locations

Country	Name	City	State
Switzerland	Kantonsspital Graubünden	Chur	GR
Switzerland	Luzerner Kantonsspital	Luzern	LU
Switzerland	Kantonsspital St. Gallen	St. Gallen	SG
Switzerland	Kantonsspital Winterthur	Winterthur	ZH
Switzerland	Universitätsspital Zürich	Zürich	ZH

Sponsors (2)

Lead Sponsor	Collaborator
Patrick Veit-Haibach	Roche Pharma AG

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	one year	No
Secondary	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	one year	No
Secondary	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)	four years	No
Secondary	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	one year	No
Secondary	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)	one year	No
Secondary	Local and distant recurrences	Rates of local and distant recurrences according to RECIST 1.1 criteria	one year	No