Bevacizumab, an anti-angiogenic agent, plus fluorouracil based chemotherapy is considered a new standard for the treatment of metastatic colorectal cancer. Contrast-enhanced ultrasound with gas-encapsulated microbubbles can be used to assess tumour vascularity, particularly hepatic metastases, and may become a useful tool for monitoring anti-angiogenic therapies. The aim of this prospective, multicenter, non-randomized study is to evaluate the usefulness of hepatic contrast-enhanced ultrasound to predict response to bevacizumab based chemotherapy in patient with metastatic colorectal cancer. The primary objective of this study is to compare the functional vascular changes related to bevacizumab based chemotherapy and evaluated by hepatic contrast-enhanced ultrasound with classic RECIST criteria. The secondary objectives are to do a characterization of the pharmacokinetic of bevacizumab, to explore the pharmacodynamic effects of bevacizumab on functional vascular changes of hepatic metastases evaluated by hepatic contrast-enhanced ultrasound and to analyze the possible relationships between treatment efficacy or toxicity and constitutional gene polymorphisms linked to the bevacizumab.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
200
Real time contrast enhanced sonography was performed using an ultrasound dedicated system after bolus injection of 1.2 and 2x2.4 ml Sonovue ® (Bracco, Milan, Italy)
CHRU d'ANGERS
Angers, France
CRLCC, Centre Paul Papin
Angers, France
CHRU Besancon
Besançon, France
Hôpital Saint-André, CHRU Bordeaux
Bordeaux, France
CRLCC, Centre René Gauducheau
Nantes Saint Herblain, France
Hôpital Pitié Salpétrière, Assistance Publique Hôpitaux de Paris
Paris, France
Hôpital Haut-Lévêque
Pessac, France
Hôpital La Milétrie, CHRU Poitiers
Poitiers, France
Hôpital Robert Debré, CHRU Reims
Reims, France
CHU Pontchaillou
Rennes, France
...and 2 more locations
functional vascular changes in tumour vascularity of hepatic metastases
Time frame: 2 months
Pharmacokinetic of bevacizumab between each cure of bevacizumab based chemotherapy
Time frame: 2 months
ratio cost/benefit of a strategy of therapeutic monitoring by contrast-enhanced ultrasound
Time frame: 2 months
evaluation of the response to bevacizumab based chemotherapy by RECIST criteria
Time frame: 2 months
bevacizumab-related toxicity
Time frame: 2 months
response duration
Time frame: 2 years
time to disease progression
Time frame: 2 years
survival time
Time frame: 2 years
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