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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 : May 14, 2018
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

January 5, 2012
January 9, 2012
May 14, 2018
July 6, 2012
March 10, 2017   (Final data collection date for primary outcome measure)
  • Percentage of Participants with Serious Adverse Events (SAEs) [ Time Frame: 1.5 years ]
    An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires new in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is a significant medical event in the investigator's judgment or requires intervention to prevent one or other of these outcomes.
  • Percentage of Participants with Grade 3-5 Avastin Related Adverse Events [ Time Frame: 1.5 years ]
    An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, regardless of causal attribution. Adverse events were graded according to NCI-CTCAE, v4.0 (National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0).
  • Progression-Free Survival [ Time Frame: 1.5 years ]
    Progression-Free Survival (PFS) was defined as the number of days from start of first-line therapy administration (earliest date of either the start of chemotherapy regimen administration or the start of Avastin) to the date of first occurrence of investigator-assessed disease progression or death. PFS was assessed using Kaplan-Meier method.
  • Overall Survival [ Time Frame: 1.5 years ]
    Overall Survival (OS) is defined as the number of days from the start of first-line therapy (earliest date of either the start of chemotherapy regimen administration or the start of Avastin) to death by any cause.
  • 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 ]
Complete list of historical versions of study NCT01506167 on ClinicalTrials.gov Archive Site
  • Percentage of Participants with Avastin Related Adverse Events of Special Interest [ Time Frame: 1.5 years ]
    Adverse events of special interest (AESIs) are defined by their possible association with Avastin® treatment. The adverse events of special interest in this study include all grades of gastrointestinal perforation, fistulae, arterial and venous thromboembolic events, congestive heart failure and pulmonary haemorrhages; and Grade 2-5: hypertension, wound healing complications, proteinuria and mucocutaneous haemorrhages.
  • Reasons for Discontinuation of Avastin [ Time Frame: 1.5 years ]
  • Median Progression Free Survival from Four Avastin Studies [ Time Frame: 1.5 years (ACORN) ]
    PFS was defined as the number of days from start of first-line therapy administration (earliest date of either the start of chemotherapy regimen administration or the start of Avastin) to the date of first occurrence of investigator-assessed disease progression or death. The BRITE, BEAT and ARIES trials were conducted outside of the UK unlike the ACORN trial which was conducted in England only. Median PFS is presented for data from other registration trials and similar observational studies.
  • Median Overall Survival from Four Avastin Studies [ Time Frame: 1.5 years (ACORN) ]
    OS is defined as the number of days from the start of first-line therapy (earliest date of either the start of chemotherapy regimen administration or the start of Avastin) to death by any cause. The BRITE, BEAT and ARIES trials were conducted outside of the UK unlike the ACORN trial which was conducted in England only. Median OS is presented for data from other registration trials and similar observational studies.
  • Percentage of Participants with Comparative AEs from Four Avastin® Studies [ Time Frame: 1.5 years (ACORN) ]
    Comparative AEs included Gastrointestinal perforation; Haemorrhage (specific grade); All Haemorrhages; Hypertension; and Arterial thromboembolic events (cerebrovascular accident, myocardial infarction, transient ischaemic attack and other). The specific grade of haemorrhage was 3/4 for BRITE, 3/4 for BEAT and 3-5 for ARIES. The specific grade for ACORN was unknown. The BRITE, BEAT and ARIES trials were conducted outside of the UK unlike the ACORN trial which was conducted in England only.
  • Median Age of Participants in Four Avastin® Studies [ Time Frame: Baseline ]
    The BRITE, BEAT and ARIES trials were conducted outside of the UK unlike the ACORN trial which was conducted in England only.
  • Percentage of Participants Over (or equal to) 75 Years of Age in Four Avastin Studies [ Time Frame: Baseline ]
    The BRITE, BEAT and ARIES trials were conducted outside of the UK unlike the ACORN trial which was conducted in England only.
  • Percentage of Males and Females in Four Avastin Studies [ Time Frame: Baseline ]
    The BRITE, BEAT and ARIES trials were conducted outside of the UK unlike the ACORN trial which was conducted in England only.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status in Four Avastin Studies [ Time Frame: 1.5 years (ACORN) ]
    ECOG Performance Status measured on-therapy (time between first dose and last dose date) assessed participant's performance status on 5 point scale: 0 is equal to (=) fully active/able to carry on all pre-disease activities without restriction; 1=restricted in physically strenuous activity, ambulatory/able to carry out light or sedentary work; 2=ambulatory (greater than [>] 50% of waking hours [hrs]), capable of all self care, unable to carry out any work activities; 3=capable of only limited self care, confined to bed/chair >50% of waking hrs; 4=completely disabled, cannot carry on any self care, totally confined to bed/chair; 5=dead. The BRITE, BEAT and ARIES trials were conducted outside of the UK unlike the ACORN trial which was conducted in England only.
  • Race/Ethnicity of Participants in Four Avastin Studies [ Time Frame: Baseline ]
    The BRITE, BEAT and ARIES trials were conducted outside of the UK unlike the ACORN trial which was conducted in England only.
  • Percentage of Participants at Stage IV (at diagnosis) in Four Avastin Studies [ Time Frame: Baseline ]
    The BRITE, BEAT and ARIES trials were conducted outside of the UK unlike the ACORN trial which was conducted in England only.
  • Percentage of Participants that Received Previous Systematic Treatment for CRC in Four Avastin Studies [ Time Frame: Baseline ]
    The BRITE, BEAT and ARIES trials were conducted outside of the UK unlike the ACORN trial which was conducted in England only.
  • Sites of CRC in Four Avastin Studies [ Time Frame: Baseline ]
    The BRITE, BEAT and ARIES trials were conducted outside of the UK unlike the ACORN trial which was conducted in England only.
  • Percentage of Participants with Primary Resection in Four Avastin Studies [ Time Frame: Baseline ]
    The BRITE, BEAT and ARIES trials were conducted outside of the UK unlike the ACORN trial which was conducted in England only.
  • Metastatic Sites of CRC in Four Avastin Studies [ Time Frame: Baseline ]
    The BRITE, BEAT and ARIES trials were conducted outside of the UK unlike the ACORN trial which was conducted in England only.
  • Ongoing Patient Medical Conditions in Four Avastin Studies [ Time Frame: Baseline ]
    The BRITE, BEAT and ARIES trials were conducted outside of the UK unlike the ACORN trial which was conducted in England only.
  • Weeks of Further Treatment After 1st Line Chemotherapy [ Time Frame: From disease progression until end of study. ]
    Number of weeks of further chemotherapy regimen administered after 1st line treatment.
  • Quality of Life as Assessed by the Euro-Quality of Life-5 Dimensions (EQ-5D) Weighted Index Score [ Time Frame: Baseline and 3, 6, 9, 12, 15, 18, 21, 24 and 27 Months post chemotherapy ]
    The EQ-5D is composed of 5 single-item measures where participants responded to questions assessing health status by responding with either "no problems", "slight problems", "moderate problems", "severe problems" or "extreme [problem]/unable to perform" in the following categories: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Based on population surveys, an algorithm was used to combine the responses to each of these 5 measures into 1 single EQ-5D weighted index score ranging from -0.59 (extreme problems) to +1 (no problems) where a negative value indicated a worsening of perceived quality of life and a positive value indicated an improvement of perceived quality of life.
  • Quality of Life as Assessed by the Euro-Quality of Life-5 Dimensions (EQ-5D) Crosswalk Index Score [ Time Frame: Baseline and 3, 6, 9, 12, 15, 18, 21, 24 and 27 Months post chemotherapy ]
    The EQ-5D is composed of 5 single-item measures where participants responded to questions assessing health status by responding with either "no problems", "slight problems", "moderate problems", "severe problems" or "extreme [problem]/unable to perform" in the following categories: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Based on population surveys, an algorithm was used to combine the responses to each of these 5 measures into 1 single EQ-5D index score ranging from -0.59 (extreme problems) to +1 (no problems) where a negative value indicated a worsening of perceived quality of life and a positive value indicated an improvement of perceived quality of life.
  • Response to the Burden of Illness Question: In the last three months how many times have health care professionals been to your home? [ Time Frame: Baseline and 3, 6, 9, 12, 15, 18, 21, 24 and 27 Months post chemotherapy ]
  • Response to the Burden of Illness Question: In the last three months how many times have you seen health care professionals at your GP Surgery or day centre? [ Time Frame: Baseline and 3, 6, 9, 12, 15, 18, 21, 24 and 27 Months post chemotherapy ]
  • Response to the Burden of Illness Question: In the last three months how many nights in total did you spend in hospital/hospice? [ Time Frame: Baseline and 3, 6, 9, 12, 15, 18, 21, 24 and 27 Months post chemotherapy ]
  • Response to the Burden of Illness Question: In the last three months how many times did you visit the imaging department for these examinations? [ Time Frame: Baseline and 3, 6, 9, 12, 15, 18, 21, 24 and 27 Months post chemotherapy ]
  • Response to the Burden of Illness Question: What was your employment status before diagnosis? [ Time Frame: Baseline ]
  • Response to the Burden of Illness Question: What is your employment status now? [ Time Frame: Baseline and 3, 6, 9, 12, 15, 18, 21, 24 and 27 Months post chemotherapy ]
  • Response to the Burden of Illness Question: Has your cancer resulted in you seeking support services? [ Time Frame: Baseline and 3, 6, 9, 12, 15, 18, 21, 24 and 27 Months post chemotherapy ]
  • Response to the Burden of Illness Question: Has a previously employed family member had to take time off work to care for you? [ Time Frame: Baseline and 3, 6, 9, 12, 15, 18, 21, 24 and 27 Months post chemotherapy ]
  • Response to the Burden of Illness Question: Has your cancer resulted in a family member seeking support? [ Time Frame: Baseline and 3, 6, 9, 12, 15, 18, 21, 24 and 27 Months post chemotherapy ]
  • 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 ]
Not Provided
Not Provided
 
An Observational Study of Avastin (Bevacizumab) in Patients With Metastatic Colorectal Cancer (ACORN)
An Observational Study of Avastin® (Bevacizumab) in Combination With Chemotherapy for Treatment of First-line Metastatic Colorectal Adenocarcinoma
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.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample
Adult patients diagnosed with metastatic colorectal cancer
Colorectal Cancer
  • Drug: Bevacizumab
    Bevacizumab was administered as part of standard first-line treatment
    Other Name: Avastin®
  • Drug: Capecitabine/Oxaliplatin
    Capecitabine/oxaliplatin were administered along with bevacizumab as part of standard first-line treatment
  • Drug: Fluorouracil/Folinic Acid/Oxaliplatin
    Fluorouracil/folinic acid/oxaliplatin were administered along with bevacizumab as part of standard first-line treatment
  • Drug: Capecitabine
    Capecitabine was administered along with bevacizumab as part of standard first-line treatment
  • Drug: Fluorouracil/Folinic Acid/Irinotecan
    Fluorouracil/folinic acid/irinotecan were administered along with bevacizumab as part of standard first-line treatment
  • Drug: Fluorouracil +/- Folinic Acid
    Fluorouracil +/- folinic acid were administered along with bevacizumab as part of standard first-line treatment
  • Bevacizumab and Capecitabine/Oxaliplatin
    Participants who receive bevacizumab in combination with capecitabine/oxaliplatin
    Interventions:
    • Drug: Bevacizumab
    • Drug: Capecitabine/Oxaliplatin
  • Bevacizumab and Fluorouracil/Folinic Acid/Oxaliplatin
    Participants who receive bevacizumab in combination with fluorouracil/folinic acid/oxaliplatin
    Interventions:
    • Drug: Bevacizumab
    • Drug: Fluorouracil/Folinic Acid/Oxaliplatin
  • Bevacizumab and Capecitabine
    Participants who receive bevacizumab in combination with capecitabine
    Interventions:
    • Drug: Bevacizumab
    • Drug: Capecitabine
  • Bevacizumab and Fluorouracil/Folinic Acid/Irinotecan
    Participants who receive bevacizumab in combination with fluorouracil/folinic acid/irinotecan
    Interventions:
    • Drug: Bevacizumab
    • Drug: Fluorouracil/Folinic Acid/Irinotecan
  • Bevacizumab and Capecitabine/Irinotecan
    Participants who receive bevacizumab in combination with capecitabine/irinotecan
    Intervention: Drug: Bevacizumab
  • Bevacizumab and Fluorouracil +/- Folinic Acid
    Participants who receive bevacizumab in combination with fluorouracil +/- folinic acid
    Interventions:
    • Drug: Bevacizumab
    • Drug: Fluorouracil +/- Folinic Acid
  • Other
    Participants who receive bevacizumab in combination with other first-line chemotherapy regimens
    Intervention: Drug: Bevacizumab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
719
1000
March 10, 2017
March 10, 2017   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
 
NCT01506167
ML27971
Not Provided
Studies a U.S. FDA-regulated Drug Product: No
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
May 2018