BEVACAPI
Sponsor study identifier
interventional
47
1 country
1
Study Start
May 2013
Actual (reported)Primary Completion
May 2015
Actual (reported)Study Completion
May 2015
Actual (reported)The treatment of the most common cancers (colon, breast, lung, liver and kidney) has recently added a new therapeutic class known as the "anti-angiogenic". It was born from a better understanding of tumor growth requires the development of neo-vessels. These new vessels are of major importance for the viability of the tumor but also the birth of metastases. This neo-angiogenesis is complex and results from an imbalance between pro-angiogenic factors and anti-angiogenic factors. Growth factor VEGF and its receptors (VEGFR-1, VEGFR-2 and VEGFR-3) are a way of survival of endothelial cells required for tumor neoangiogenesis. The anti-angiogenic drugs currently available on the market are bevacizumab (Avastin ®), sunitinib (Sutent ®) and sorafenib (Nexavar ®). The mechanism of anti-angiogenic action of these three main drugs are pharmacological inhibition of the VEGF pathway. These new anti-angiogenic therapies, however, have significant adverse effects are common and some other more serious but rare. Hypertension is the most common side effect observed in patients treated with anti-VEGF. This is usually iatrogenic hypertension controlled by antihypertensive therapy and rarely compromises the pursuit of anti-angiogenic therapy. More rarely, it can have serious consequences malignant hypertension, severe hypertension refractory reversible posterior leukoencephalopathy associated with severe hypertension have also been reported. The pathophysiology of hypertension may be due to the neutralization of major physiological effects of VEGF in endothelial cell and therefore the vascular wall. The study of the microcirculation is not only useful in the diagnosis of microvascular but also macrovascular disease in the evaluation of chronic arterial and venous severe it determines the prognosis. In these indications, capillaroscopy remains the gold standard for all work pathophysiological because visualization of phenomena measured avoids artifacts and difficulties of interpretation. It then appealed to additional technology to directly measure the capillary pressure, capillary flow velocity, and indirectly assess capillary permeability and function of lymphatic canaliculi. The simplest of these technological inputs: video microscopy and digital image analysis, have also improved the practice of routine clinical capillaroscopy in its main field of application, evaluation of microangiopathy connective. The examination can be performed more quickly and easily archived and quantified. Only two studies on 14 and 16 patients were able to see a decrease in capillary density correlated with the therapeutic activity of anti-angiogenic the tumor mass and metastasis. Thus, we propose to quantify in a number of relatively large patient patients the decrease in capillary density as well as the relationship between the decrease in the number of capillaries and anti-tumor response. The study will also aim to measure the prevalence of hypertension in patients treated with bevacizumab and to establish the link between these data and the modification of the capillary microcirculation.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 2015
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 12, 2013
Actual (reported)March 13, 2013
Actual (reported)May 2013
Actual (reported)May 2015
Actual (reported)May 2015
Actual (reported)change in the density of capillaries
The change in the density of capillaries visualized by periungual capillaroscopy will be quantify after 15 days of treatment with bevacizumab, in patients with metastatic colon cancer or a brain tumor.
baseline and after 15 days of bevacizumab treatment
Patients treated by bevacizumab will be follow up by capillaroscopy and blood pressure measurements.
Patients treated by bevacizumab will be follow up by capillaroscopy and blood pressure measurements.
Centre Georges François Leclerc
Dijon, 21079, France
Fumet JD, Bertaut A, Bengrine L, Lapierre P, Vincent J, Ghiringhelli F, Falvo N. Capillary density has no value as an early biomarker of bevacizumab efficacy in metastatic colorectal cancers: a prospective clinical trial. Oncotarget. 2017 Dec 1;9(16):12599-12608. doi: 10.18632/oncotarget.22822. eCollection 2018 Feb 27.
François Ghiringhelli, Professor
Centre Georges Francois Leclerc
47 participants (actual enrollment reported by the registry).
First Submitted
March 12, 2013
First Posted
March 13, 2013
Study Start
May 2013
Actual (reported)Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Primary Completion
May 2015
Actual (reported)Study Completion
May 2015
Actual (reported)Last Updated
March 15, 2019
Record last verified: 2017-06
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Source: ClinicalTrials.gov.
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