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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00489697
Recruitment Status : Completed
First Posted : June 21, 2007
Last Update Posted : January 4, 2017
Sponsor:
Information provided by:
University Hospital, Tours

Tracking Information
First Submitted Date  ICMJE June 20, 2007
First Posted Date  ICMJE June 21, 2007
Last Update Posted Date January 4, 2017
Study Start Date  ICMJE January 2007
Actual Primary Completion Date November 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 20, 2007)
  • 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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00489697 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 20, 2007)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of Contrast-enhanced Ultrasound Imaging for the Early Estimate of Bevacizumab Effect on Colorectal Cancer Liver Metastases
Official Title  ICMJE Medical and Economical Evaluation of Contrast-enhanced Ultrasound Imaging for the Early Estimate of Bevacizumab Effect on Colorectal Cancer Liver Metastases
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Metastatic Colorectal Cancer
Intervention  ICMJE 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)
Study Arms  ICMJE 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)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: June 20, 2007)
200
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2012
Actual Primary Completion Date November 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00489697
Other Study ID Numbers  ICMJE INCA06-FT/STIC-AVASTIN
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Directrice de la Recherche et des Affaires Médicales, University Hospital Tours
Study Sponsor  ICMJE University Hospital, Tours
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account University Hospital, Tours
Verification Date January 2017

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