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An Observational Study of Avastin (Bevacizumab) in Patients With Metastatic Colorectal Cancer (ACORN)
This study has been completed.
Sponsor:
Hoffmann-La Roche
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01506167
First received: January 5, 2012
Last updated: June 12, 2017
Last verified: November 2016
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Purpose
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 |
|---|
| Colorectal Cancer |
| Study Type: | Observational |
| Study Design: | 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 |
Resource links provided by NLM:
MedlinePlus related topics:
Colorectal Cancer
Drug Information available for:
Bevacizumab
U.S. FDA Resources
Further study details as provided by Hoffmann-La Roche:
Primary Outcome Measures:
- Safety (incidence of serious adverse events) [ Time Frame: 1.5 years ]
- Safety (incidence of Grade3-5 Avastin related events) [ Time Frame: 1.5 years ]
- Progression-free survival [ Time Frame: 1.5 years ]
- Duration of survival [ Time Frame: 1.5 years ]
Secondary Outcome Measures:
- Safety (incidence of Avastin related adverse of special interest) [ Time Frame: 1.5 years ]
- Type of treatment regimen [ Time Frame: 1.5 years ]
- Reason for treatment discontinuation [ Time Frame: 1.5 years ]
- Difference of patient demographics in this trial and in other studies [ Time Frame: 1.5 years ]
- Treatment compliance [ Time Frame: 1.5 years ]
- Treatment regimen for metastatic colorectal cancer after 1st line treatment with chemotherapy and Avastin [ Time Frame: 1.5 years ]
- Quality of Life questionnaire (EQ-5D 5L) [ Time Frame: 1.5 years ]
- Burden of Illness questionnaire [ Time Frame: 1.5 years ]
| Enrollment: | 719 |
| Actual Study Start Date: | July 6, 2012 |
| Study Completion Date: | November 14, 2016 |
| Primary Completion Date: | November 14, 2016 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
| Cohort |
Eligibility| 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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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01506167
Please refer to this study by its ClinicalTrials.gov identifier: 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
| Responsible Party: | Hoffmann-La Roche |
| ClinicalTrials.gov Identifier: | NCT01506167 History of Changes |
| Other Study ID Numbers: |
ML27971 |
| Study First Received: | January 5, 2012 |
| Last Updated: | June 12, 2017 |
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 |
ClinicalTrials.gov processed this record on July 19, 2017