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An Observational Study of Avastin (Bevacizumab) in Patients With Metastatic Colorectal Cancer (ACORN)

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ClinicalTrials.gov Identifier: NCT01506167
Recruitment Status : Completed
First Posted : January 9, 2012
Last Update Posted : June 14, 2017
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Description
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Brief Summary:
This prospective, multi-center, observational study will assess the safety and efficacy of Avastin (bevacizumab) in daily practice in patients with metastatic colorectal cancer who have received no previous treatment for advanced disease and are receiving Avastin in combination with a standard of care first-line chemotherapy regimen. Data will be collected for 1.5 years or until death.

Condition or disease
Colorectal Cancer

Study Design
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Study Type : Observational
Actual Enrollment : 719 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: An Observational Study of Avastin® (Bevacizumab) in Combination With Chemotherapy for Treatment of First-line Metastatic Colorectal Adenocarcinoma
Actual Study Start Date : July 6, 2012
Actual Primary Completion Date : November 14, 2016
Actual Study Completion Date : November 14, 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Bevacizumab
U.S. FDA Resources

Groups and Cohorts
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Group/Cohort
Cohort


Outcome Measures
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Primary Outcome Measures :
  1. Safety (incidence of serious adverse events) [ Time Frame: 1.5 years ]
  2. Safety (incidence of Grade3-5 Avastin related events) [ Time Frame: 1.5 years ]
  3. Progression-free survival [ Time Frame: 1.5 years ]
  4. Duration of survival [ Time Frame: 1.5 years ]

Secondary Outcome Measures :
  1. Safety (incidence of Avastin related adverse of special interest) [ Time Frame: 1.5 years ]
  2. Type of treatment regimen [ Time Frame: 1.5 years ]
  3. Reason for treatment discontinuation [ Time Frame: 1.5 years ]
  4. Difference of patient demographics in this trial and in other studies [ Time Frame: 1.5 years ]
  5. Treatment compliance [ Time Frame: 1.5 years ]
  6. Treatment regimen for metastatic colorectal cancer after 1st line treatment with chemotherapy and Avastin [ Time Frame: 1.5 years ]
  7. Quality of Life questionnaire (EQ-5D 5L) [ Time Frame: 1.5 years ]
  8. Burden of Illness questionnaire [ Time Frame: 1.5 years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Adult patients diagnosed with metastatic colorectal cancer
Criteria

Inclusion Criteria:

  • Adult patients, >/= 18 years of age
  • Metastatic colorectal cancer with no previous systemic treatment for advanced disease
  • Receiving Avastin in combination with a first-line standard of care chemotherapy regimen
  • Avastin initiated at the same time as first-line chemotherapy regimen

Exclusion Criteria:

  • Investigational, non-standard of care first-line chemotherapy regimen for treatment of metastatic colorectal cancer
  • Contraindication to Avastin
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01506167


Locations
United Kingdom
Bath, United Kingdom, BA1 3NG
Berkshire, United Kingdom, SL2 4HL
Birmingham, United Kingdom, B15 2TH
Birmingham, United Kingdom, B9 5SS
Bishop Auckland, United Kingdom, DL14 6AD
Blackpool, United Kingdom, FY3 8NR
Bradford, United Kingdom, BD9 6RJ
Bristol, United Kingdom, BS2 8ED
Bury St Edmunds, United Kingdom, IP33 2QZ
Canterbury, United Kingdom, CT1 3NG
Carlisle, United Kingdom, CA2 7HY
Chelsmford, United Kingdom, CM1 7ET
Cleveland, United Kingdom, TS19 8PE
Cottingham, United Kingdom, HU16 5JQ
Darlington, United Kingdom, DL3 6HX
Dudley, United Kingdom, DY1 2HQ
Durham, United Kingdom, DH15TW
Harrogate, United Kingdom, HG2 8AY
Harrow, United Kingdom, HA1 3UJ
Ipswich, United Kingdom, IP4 5PD
Kidderminster, United Kingdom, DY11 6RJ
London, United Kingdom, NW3 2QG
London, United Kingdom, SE1 9RT
London, United Kingdom, SE18 4QH
Macclesfield, United Kingdom, SK10 3BL
Maidstone, United Kingdom, ME16 9QQ
Middlesborough, United Kingdom, TS4 3BW
Newcastle upon Tyne, United Kingdom, NE7 7DN
North Shields, United Kingdom, NE29 8NH
Northwood, United Kingdom, HA6 2RN
Nottingham, United Kingdom, NG5 1PB
Peterborough, United Kingdom, PE3 9GZ
Plymouth, United Kingdom, PL6 8DH
Romford, United Kingdom, RM7 0AG
Scunthorpe, United Kingdom, DN16 7BH
Stafford, United Kingdom, ST16 3SA
Sutton, United Kingdom, SM2 5PT
Swindon, United Kingdom, SN3 6BB
Torquay, United Kingdom, TQ2 7AA
Truro, United Kingdom, TR1 3LJ
Walsall, United Kingdom, WS2 9PS
Winchester, United Kingdom, SO22 5DG
Wolverhampton, United Kingdom, WV10 0QP
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01506167     History of Changes
Other Study ID Numbers: ML27971
First Posted: January 9, 2012    Key Record Dates
Last Update Posted: June 14, 2017
Last Verified: November 2016

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
 Intestinal Diseases
Rectal Diseases
Bevacizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents