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


N/A
18 Years
80 Years
Open (Enrolling)
Both
Metastatic Colorectal Cancer

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

functional vascular changes in tumour vascularity of hepatic metastases

Outcome Time Frame:

2 months

Safety Issue:

No

Principal Investigator

François TRANQUART, Professor

Investigator Role:

Principal Investigator

Investigator Affiliation:

Centre Hospitalier de Tours, France

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

INCA06-FT/STIC-AVASTIN

NCT ID:

NCT00489697

Start Date:

January 2007

Completion Date:

March 2010

Related Keywords:

  • Metastatic Colorectal Cancer
  • colorectal cancer
  • hepatic metastases
  • bevacizumab
  • anti-angiogenic agent
  • chemotherapy regimens
  • tumor vascularity
  • Contrast-enhanced ultrasound
  • Colorectal Neoplasms
  • Neoplasm Metastasis

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