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Evaluation of Contrast-Enhanced Ultrasound Imaging for the Early Estimate of Bevacizumab Effect on Colorectal Cancer Liver Metastases

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by University Hospital, Tours.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University Hospital, Tours
ClinicalTrials.gov Identifier:
NCT00489697
First received: June 20, 2007
Last updated: February 19, 2009
Last verified: February 2009

June 20, 2007
February 19, 2009
January 2007
March 2010   (final data collection date for primary outcome measure)
  • functional vascular changes in tumour vascularity of hepatic metastases [ Time Frame: 2 months ] [ Designated as safety issue: No ]
  • Pharmacokinetic of bevacizumab between each cure of bevacizumab based chemotherapy [ Time Frame: 2 months ] [ Designated as safety issue: No ]
  • ratio cost/benefit of a strategy of therapeutic monitoring by contrast-enhanced ultrasound [ Time Frame: 2 months ] [ Designated as safety issue: No ]
  • evaluation of the response to bevacizumab based chemotherapy by RECIST criteria [ Time Frame: 2 months ] [ Designated as safety issue: No ]
  • 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 ]
Complete list of historical versions of study NCT00489697 on ClinicalTrials.gov Archive Site
  • bevacizumab-related toxicity [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]
  • response duration [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • time to disease progression [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • survival time [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • 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 ]
Not Provided
Not Provided
 
Evaluation of Contrast-Enhanced Ultrasound Imaging for the Early Estimate of Bevacizumab Effect on Colorectal Cancer Liver Metastases
Medical and Economical Evaluation of Contrast-Enhanced Ultrasound Imaging for the Early Estimate of Bevacizumab Effect on Colorectal Cancer Liver Metastases

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.

Not Provided
Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Metastatic Colorectal Cancer
Device: real-time contrast-enhanced ultrasound imaging (CEUS)
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)
Experimental: 1 (single arm)
patient with histologically confirmed colorectal tumor treated in first line by a bevacizumab based chemotherapy
Intervention: Device: real-time contrast-enhanced ultrasound imaging (CEUS)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
March 2010
March 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Histologically confirmed colorectal tumor
  • first line treatment by a bevacizumab based chemotherapy
  • Target hepatic metastases of size lower than 5 cm and higher than 5 mm detected by conventional ultrasonography and CT or MRI
  • Life expectancy > 2 months
  • OMS status =< 2
  • Major surgery, open biopsy, or significant traumatic injury within 28 days prior to Day 0
  • informed consent signed

Exclusion Criteria:

  • no target hepatic lesion detected by conventional ultrasonography
  • Prior bevacizumab treatment
  • Prior chemotherapy treatment for advanced disease
  • Clinically significant cardiac disease (e.g. myocardial infarction or stroke within 12 months, unstable angina, New York Heart Association (NYHA) Grade II or greater congestive heart failure not well controlled with medication, endocarditis and prosthetic valve) and any contraindications in sulphur hexafluoride administration
  • Blood pressure >= 180/110 mmHg
  • Daily and chronic treatment by aspirin or AINS
  • Anticipation of need for major surgical procedure within 7 days prior day 0
  • Urine protein > 1g/24 Hours
  • Any contraindication in enhancing bevacizumab treatment
  • Serious, uncontrolled, concurrent infection(s) or illness(es)
  • pregnant and lactating woman
Both
18 Years to 80 Years
No
Contact: François TRANQUART, Professor 33 2 47 47 38 48 tranquart@med.univ-tours.fr
Contact: Thierry LECOMTE, Doctor 33 2 47 47 47 47 ext 71730 lecomt_t@med.univ-tours.fr
France
 
NCT00489697
INCA06-FT/STIC-AVASTIN
No
Directrice de la Recherche et des Affaires Médicales, University Hospital Tours
University Hospital, Tours
Not Provided
Principal Investigator: François TRANQUART, Professor Centre Hospitalier de Tours, France
Principal Investigator: Thierry LECOMTE, Doctor Centre Hospitalier de Tours, France
Study Chair: Bruno GIRAUDEAU, Doctor INSERM CIC 2002, Centre Hospitalier de Tours, France
Study Chair: Emmanuel RUSCH, Professor Centre Hospitalier de Tours, France
University Hospital, Tours
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP