An Observational Study of Avastin (Bevacizumab) in Patients With Metastatic Colorectal Cancer (ACORN)
- Conditions
- Colorectal Cancer
- Interventions
- Drug: BevacizumabDrug: Capecitabine/OxaliplatinDrug: Fluorouracil/Folinic Acid/OxaliplatinDrug: Fluorouracil/Folinic Acid/IrinotecanDrug: Fluorouracil +/- Folinic AcidDrug: Capecitabine
- Registration Number
- NCT01506167
- Lead Sponsor
- Hoffmann-La Roche
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 719
- 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
- Investigational, non-standard of care first-line chemotherapy regimen for treatment of metastatic colorectal cancer
- Contraindication to Avastin
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Bevacizumab and Capecitabine/Oxaliplatin Bevacizumab Participants who receive bevacizumab in combination with capecitabine/oxaliplatin Bevacizumab and Capecitabine/Oxaliplatin Capecitabine/Oxaliplatin Participants who receive bevacizumab in combination with capecitabine/oxaliplatin Bevacizumab and Fluorouracil/Folinic Acid/Oxaliplatin Bevacizumab Participants who receive bevacizumab in combination with fluorouracil/folinic acid/oxaliplatin Bevacizumab and Fluorouracil/Folinic Acid/Oxaliplatin Fluorouracil/Folinic Acid/Oxaliplatin Participants who receive bevacizumab in combination with fluorouracil/folinic acid/oxaliplatin Bevacizumab and Fluorouracil/Folinic Acid/Irinotecan Fluorouracil/Folinic Acid/Irinotecan Participants who receive bevacizumab in combination with fluorouracil/folinic acid/irinotecan Bevacizumab and Capecitabine/Irinotecan Bevacizumab Participants who receive bevacizumab in combination with capecitabine/irinotecan Bevacizumab and Fluorouracil +/- Folinic Acid Bevacizumab Participants who receive bevacizumab in combination with fluorouracil +/- folinic acid Bevacizumab and Fluorouracil +/- Folinic Acid Fluorouracil +/- Folinic Acid Participants who receive bevacizumab in combination with fluorouracil +/- folinic acid Bevacizumab and Capecitabine Bevacizumab Participants who receive bevacizumab in combination with capecitabine Bevacizumab and Capecitabine Capecitabine Participants who receive bevacizumab in combination with capecitabine Bevacizumab and Fluorouracil/Folinic Acid/Irinotecan Bevacizumab Participants who receive bevacizumab in combination with fluorouracil/folinic acid/irinotecan Other Bevacizumab Participants who receive bevacizumab in combination with other first-line chemotherapy regimens
- Primary Outcome Measures
Name Time Method Percentage of Participants with Serious Adverse Events (SAEs) 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 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 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 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.
- Secondary Outcome Measures
Name Time Method Percentage of Participants with Avastin Related Adverse Events of Special Interest 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 1.5 years Median Progression Free Survival from Four Avastin Studies 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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? 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? 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? 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? 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? Baseline Response to the Burden of Illness Question: What is your employment status now? 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? 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? 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? Baseline and 3, 6, 9, 12, 15, 18, 21, 24 and 27 Months post chemotherapy
Trial Locations
- Locations (42)
Walsall Manor Hospital
🇬🇧Walsall, United Kingdom
University Hospital of North Staffordhire
🇬🇧Blackpool, United Kingdom
Royal United Hospital Bath; Diabetes and Lipid Research, Wolfson Centre
🇬🇧Bath, United Kingdom
Bishop Auckland Hospital;Oncology Department
🇬🇧Bishop Auckland, United Kingdom
West Suffolk Hospital Nhs Trust; Gi Corridor
🇬🇧Bury St Edmunds, United Kingdom
Castle Hill Hospital; Academic Oncology
🇬🇧Cottingham, United Kingdom
Kent & Canterbury Hospital
🇬🇧Canterbury, United Kingdom
Queen Elizabeth Hospital
🇬🇧London, United Kingdom
Wexham Park Hospital; Oncology
🇬🇧Berkshire, United Kingdom
Darlington Memorial Hospital
🇬🇧Darlington, United Kingdom
Harrogate Hospital
🇬🇧Harrogate, United Kingdom
Birmingham Heartlands Hospital; Dept of Oncology
🇬🇧Birmingham, United Kingdom
Northhwick Park Hospital;Oncology Department
🇬🇧Harrow, United Kingdom
Russells Hall Hospital; Dept of Hematology
🇬🇧Dudley, United Kingdom
Bristol Haematology and Oncology Centre
🇬🇧Bristol, United Kingdom
Bradford Royal Infirmary; Dept of Medical Oncology C/O Ward15
🇬🇧Bradford, United Kingdom
Cumberland Infirmary; Oncology Department
🇬🇧Carlisle, United Kingdom
Broomfield Hospital; Oncology
🇬🇧Chelsmford, United Kingdom
University Hospital North Tees
🇬🇧Cleveland, United Kingdom
Ipswich Hospital; Oncology Pharmacy
🇬🇧Ipswich, United Kingdom
Kidderminster Hospital; Oncology Dept
🇬🇧Kidderminster, United Kingdom
Royal Free Hospital; Dept of Oncology
🇬🇧London, United Kingdom
Guys Hosp./Med. Onc./3rd Fl. T; Clinical Trial Office
🇬🇧London, United Kingdom
Mount Vernon Cancer Centre
🇬🇧Northwood, United Kingdom
Maidstone & Tonbridge Wells Hospital; Kent Oncology Center
🇬🇧Maidstone, United Kingdom
Macclesfield District General Hospital
🇬🇧Macclesfield, United Kingdom
Peterborough City Hospital, Edith Cavell Campus; Oncology Department
🇬🇧Peterborough, United Kingdom
Derriford Hospital; Gastroenterology
🇬🇧Plymouth, United Kingdom
Freeman Hospital
🇬🇧Newcastle upon Tyne, United Kingdom
North Tyneside General Hospital
🇬🇧North Shields, United Kingdom
The James Cook University Hospital
🇬🇧Middlesborough, United Kingdom
Nottingham University Hospitals City Campus
🇬🇧Nottingham, United Kingdom
Scunthorpe General Hospital; Dept of Oncology
🇬🇧Scunthorpe, United Kingdom
Stafford Hospital; Oncology Department
🇬🇧Stafford, United Kingdom
Queen's Hospital
🇬🇧Romford, United Kingdom
The Royal Marsden Hospital
🇬🇧Sutton, United Kingdom
Torbay Hospital; Oncology
🇬🇧Torquay, United Kingdom
Royal Cornwall Hospital; Dept of Clinical Oncology
🇬🇧Truro, United Kingdom
The Royal Wolverhampton Hospitals NHS Trust
🇬🇧Wolverhampton, United Kingdom
Royal Hampshire County Hospital; Winchester & Andover Breast Unit
🇬🇧Winchester, United Kingdom
University Hospital of North Durham; Oncology
🇬🇧Durham, United Kingdom
Great Western Hospital, Swindon Cancer Research Unit; Osprey Unit Level 3
🇬🇧Swindon, United Kingdom