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Metastatic Colorectal CancerNCT00489697

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

A study testing real-time contrast-enhanced ultrasound imaging (CEUS) in people with Metastatic Colorectal Cancer, run by University Hospital, Tours at 12 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Metastatic Colorectal Cancer
What is being tested?
real-time contrast-enhanced ultrasound imaging (CEUS)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
12 sitesFrance
Study dates
Jan 2007to Nov 2012
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 11Show fewer
  • 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

Trial locations and contacts

12 sites in 1 country.

12 sites in 1 country

France12 sites

  • CHRU d'ANGERS

    Angers, 49033

  • CRLCC, Centre Paul Papin

    Angers, 49033

  • CHRU Besancon

    Besançon, 25000

  • Hôpital Saint-André, CHRU Bordeaux

    Bordeaux, 33075

  • CRLCC, Centre René Gauducheau

    Nantes Saint Herblain, 44805

  • Hôpital Pitié Salpétrière, Assistance Publique Hôpitaux de Paris

    Paris, 75651

  • Hôpital Haut-Lévêque

    Pessac, 33604

  • Hôpital La Milétrie, CHRU Poitiers

    Poitiers, 86000

  • Hôpital Robert Debré, CHRU Reims

    Reims, 51092

  • CHU Pontchaillou

    Rennes, 35033

  • CRLCC, Centre Eugène Marquis

    Rennes, 35042

  • Chru Tours

    Tours, 37044

Other trials in France

About this study

Official title: 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.

Being tested
real-time contrast-enhanced ultrasound imaging (CEUS)
Keywords
colorectal cancer, hepatic metastases, bevacizumab, anti-angiogenic agent, chemotherapy regimens, tumor vascularity, Contrast-enhanced ultrasound
Medical subject headings
Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • real-time contrast-enhanced ultrasound imaging (CEUS)Device

    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 groups in NCT00489697
Study groupRoleWhat they receive
1 (single arm)Experimentalpatient with histologically confirmed colorectal tumor treated in first line by a bevacizumab based chemotherapy
Receives: Device: real-time contrast-enhanced ultrasound imaging (CEUS)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. functional vascular changes in tumour vascularity of hepatic metastases

    Measured: 2 months

  2. Pharmacokinetic of bevacizumab between each cure of bevacizumab based chemotherapy

    Measured: 2 months

  3. ratio cost/benefit of a strategy of therapeutic monitoring by contrast-enhanced ultrasound

    Measured: 2 months

  4. evaluation of the response to bevacizumab based chemotherapy by RECIST criteria

    Measured: 2 months

Secondary outcomes (4)

  1. bevacizumab-related toxicity

    Measured: 2 months

  2. response duration

    Measured: 2 years

  3. time to disease progression

    Measured: 2 years

  4. survival time

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jun 2007 (estimated)
  2. Study startJan 2007
  3. Primary completionNov 2012
  4. Study completionNov 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00489697
Sponsor's protocol ID
INCA06-FT/STIC-AVASTIN
Status last verified
Jan 2017
First submitted
20 Jun 2007
Last updated
4 Jan 2017
Results posted
No
Data monitoring committee
No

Publications

  • Bleuzen A, Huang C, Olar M, Tchuenbou J, Tranquart F. Diagnostic accuracy of contrast-enhanced ultrasound in focal lesions of the liver using cadence contrast pulse sequencing. Ultraschall Med. 2006 Feb;27(1):40-8. doi: 10.1055/s-2005-858944.

    PubMed 16470478

  • Forsberg F, Ro RJ, Potoczek M, Liu JB, Merritt CR, James KM, Dicker AP, Nazarian LN. Assessment of angiogenesis: implications for ultrasound imaging. Ultrasonics. 2004 Apr;42(1-9):325-30. doi: 10.1016/j.ultras.2003.12.026.

    PubMed 15047306

  • Broillet A, Hantson J, Ruegg C, Messager T, Schneider M. Assessment of microvascular perfusion changes in a rat breast tumor model using SonoVue to monitor the effects of different anti-angiogenic therapies. Acad Radiol. 2005 May;12 Suppl 1:S28-33. doi: 10.1016/j.acra.2005.02.021. No abstract available.

    PubMed 16106543

  • Niermann KJ, Fleischer AC, Donnelly EF, Schueneman AJ, Geng L, Hallahan DE. Sonographic depiction of changes of tumor vascularity in response to various therapies. Ultrasound Q. 2005 Jun;21(2):61-7; quiz 149, 153-4.

    PubMed 15905816

  • Preda A, Novikov V, Moglich M, Turetschek K, Shames DM, Brasch RC, Cavagna FM, Roberts TP. MRI monitoring of Avastin antiangiogenesis therapy using B22956/1, a new blood pool contrast agent, in an experimental model of human cancer. J Magn Reson Imaging. 2004 Nov;20(5):865-73. doi: 10.1002/jmri.20184.

    PubMed 15503324

  • Gerber HP, Ferrara N. Pharmacology and pharmacodynamics of bevacizumab as monotherapy or in combination with cytotoxic therapy in preclinical studies. Cancer Res. 2005 Feb 1;65(3):671-80.

    PubMed 15705858

  • Zondor SD, Medina PJ. Bevacizumab: an angiogenesis inhibitor with efficacy in colorectal and other malignancies. Ann Pharmacother. 2004 Jul-Aug;38(7-8):1258-64. doi: 10.1345/aph.1D470. Epub 2004 Jun 8.

    PubMed 15187215

  • Hurwitz H, Fehrenbacher L, Novotny W, Cartwright T, Hainsworth J, Heim W, Berlin J, Baron A, Griffing S, Holmgren E, Ferrara N, Fyfe G, Rogers B, Ross R, Kabbinavar F. Bevacizumab plus irinotecan, fluorouracil, and leucovorin for metastatic colorectal cancer. N Engl J Med. 2004 Jun 3;350(23):2335-42. doi: 10.1056/NEJMoa032691.

    PubMed 15175435

  • Chautard R, Caulet M, Bouche O, Borg C, Manfredi S, Capitain O, Spano JP, Raoul W, Gueguinou M, Herault O, Ferru A, Pobel C, Sire O, Lecomte T. Evaluation of serum mid-infrared spectroscopy as new prognostic marker for first-line bevacizumab-based chemotherapy in metastatic colorectal cancer. Dig Liver Dis. 2025 Jan;57(1):141-148. doi: 10.1016/j.dld.2024.07.022. Epub 2024 Aug 19.

    PubMed 39164167

  • Mazard T, Mollevi C, Loyer EM, Leger J, Chautard R, Bouche O, Borg C, Armand-Dujardin P, Bleuzen A, Assenat E, Lecomte T. Prognostic value of the tumor-to-liver density ratio in patients with metastatic colorectal cancer treated with bevacizumab-based chemotherapy. A post-hoc study of the STIC-AVASTIN trial. Cancer Imaging. 2024 Jun 17;24(1):77. doi: 10.1186/s40644-024-00722-7.

    PubMed 38886836

  • Lobet S, Caulet M, Paintaud G, Azzopardi N, Desvignes C, Chautard R, Borg C, Capitain O, Ferru A, Bouche O, Lecomte T, Ternant D. Confounding mitigation for the exposure-response relationship of bevacizumab in colorectal cancer patients. Br J Clin Pharmacol. 2024 Apr;90(4):976-986. doi: 10.1111/bcp.15983. Epub 2023 Dec 29.

    PubMed 38072829

  • Jary M, Lecomte T, Bouche O, Kim S, Dobi E, Queiroz L, Ghiringhelli F, Etienne H, Leger J, Godet Y, Balland J, Lakkis Z, Adotevi O, Bonnetain F, Borg C, Vernerey D. Prognostic value of baseline seric Syndecan-1 in initially unresectable metastatic colorectal cancer patients: a simple biological score. Int J Cancer. 2016 Nov 15;139(10):2325-35. doi: 10.1002/ijc.30367. Epub 2016 Aug 13.

    PubMed 27472156

Questions about this trial

What is this clinical trial studying?

A study testing real-time contrast-enhanced ultrasound imaging (CEUS) in people with Metastatic Colorectal Cancer, run by University Hospital, Tours at 12 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

functional vascular changes in tumour vascularity of hepatic metastases (time frame: 2 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00489697, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jan 2017.

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