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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bevacizumab and Capecitabine/Oxaliplatin | Participants who receive bevacizumab in combination with capecitabine/oxaliplatin |
| |
| Bevacizumab and Fluorouracil/Folinic Acid/Oxaliplatin | Participants who receive bevacizumab in combination with fluorouracil/folinic acid/oxaliplatin |
| |
| Bevacizumab and Capecitabine | Participants who receive bevacizumab in combination with capecitabine |
| |
| Bevacizumab and Fluorouracil/Folinic Acid/Irinotecan | Participants who receive bevacizumab in combination with fluorouracil/folinic acid/irinotecan |
| |
| Bevacizumab and Capecitabine/Irinotecan | Participants who receive bevacizumab in combination with capecitabine/irinotecan |
| |
| Bevacizumab and Fluorouracil +/- Folinic Acid |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bevacizumab | Drug | Bevacizumab was administered as part of standard first-line treatment |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants with Serious Adverse Events (SAEs) | 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. | 1.5 years |
| Percentage of Participants with Grade 3-5 Avastin Related Adverse Events | 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). | 1.5 years |
| Progression-Free Survival | 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. | 1.5 years |
| Overall Survival | 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. | 1.5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants with Avastin Related Adverse Events of Special Interest | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Adult patients diagnosed with metastatic colorectal cancer
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal United Hospital Bath; Diabetes and Lipid Research, Wolfson Centre | Bath | BA1 3NG | United Kingdom | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31451367 | Derived | Khakoo S, Chau I, Pedley I, Ellis R, Steward W, Harrison M, Baijal S, Tahir S, Ross P, Raouf S, Ograbek A, Cunningham D; ACORN investigators. ACORN: Observational Study of Bevacizumab in Combination With First-Line Chemotherapy for Treatment of Metastatic Colorectal Cancer in the UK. Clin Colorectal Cancer. 2019 Dec;18(4):280-291.e5. doi: 10.1016/j.clcc.2019.07.003. Epub 2019 Jul 11. |
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Participants who receive bevacizumab in combination with fluorouracil +/- folinic acid |
|
| Other | Participants who receive bevacizumab in combination with other first-line chemotherapy regimens |
|
|
| Capecitabine/Oxaliplatin | Drug | Capecitabine/oxaliplatin were administered along with bevacizumab as part of standard first-line treatment |
|
| Fluorouracil/Folinic Acid/Oxaliplatin | Drug | Fluorouracil/folinic acid/oxaliplatin were administered along with bevacizumab as part of standard first-line treatment |
|
| Capecitabine | Drug | Capecitabine was administered along with bevacizumab as part of standard first-line treatment |
|
| Fluorouracil/Folinic Acid/Irinotecan | Drug | Fluorouracil/folinic acid/irinotecan were administered along with bevacizumab as part of standard first-line treatment |
|
| Fluorouracil +/- Folinic Acid | Drug | Fluorouracil +/- folinic acid were administered along with bevacizumab as part of standard first-line treatment |
|
| 1.5 years |
| Reasons for Discontinuation of Avastin | 1.5 years |
| Median Progression Free Survival from Four Avastin Studies | 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. | 1.5 years (ACORN) |
| Median Overall Survival from Four Avastin Studies | 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. | 1.5 years (ACORN) |
| Percentage of Participants with Comparative AEs from Four Avastin® Studies | 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. | 1.5 years (ACORN) |
| Median Age of Participants in Four Avastin® Studies | The BRITE, BEAT and ARIES trials were conducted outside of the UK unlike the ACORN trial which was conducted in England only. | Baseline |
| Percentage of Participants Over (or equal to) 75 Years of Age in Four Avastin Studies | The BRITE, BEAT and ARIES trials were conducted outside of the UK unlike the ACORN trial which was conducted in England only. | Baseline |
| Percentage of Males and Females in Four Avastin Studies | The BRITE, BEAT and ARIES trials were conducted outside of the UK unlike the ACORN trial which was conducted in England only. | Baseline |
| Eastern Cooperative Oncology Group (ECOG) Performance Status in Four Avastin Studies | 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. | 1.5 years (ACORN) |
| Race/Ethnicity of Participants in Four Avastin Studies | The BRITE, BEAT and ARIES trials were conducted outside of the UK unlike the ACORN trial which was conducted in England only. | Baseline |
| Percentage of Participants at Stage IV (at diagnosis) in Four Avastin Studies | The BRITE, BEAT and ARIES trials were conducted outside of the UK unlike the ACORN trial which was conducted in England only. | Baseline |
| Percentage of Participants that Received Previous Systematic Treatment for CRC in Four Avastin Studies | The BRITE, BEAT and ARIES trials were conducted outside of the UK unlike the ACORN trial which was conducted in England only. | Baseline |
| Sites of CRC in Four Avastin Studies | The BRITE, BEAT and ARIES trials were conducted outside of the UK unlike the ACORN trial which was conducted in England only. | Baseline |
| Percentage of Participants with Primary Resection in Four Avastin Studies | The BRITE, BEAT and ARIES trials were conducted outside of the UK unlike the ACORN trial which was conducted in England only. | Baseline |
| Metastatic Sites of CRC in Four Avastin Studies | The BRITE, BEAT and ARIES trials were conducted outside of the UK unlike the ACORN trial which was conducted in England only. | Baseline |
| Ongoing Patient Medical Conditions in Four Avastin Studies | The BRITE, BEAT and ARIES trials were conducted outside of the UK unlike the ACORN trial which was conducted in England only. | Baseline |
| Weeks of Further Treatment After 1st Line Chemotherapy | Number of weeks of further chemotherapy regimen administered after 1st line treatment. | From disease progression until end of study. |
| Quality of Life as Assessed by the Euro-Quality of Life-5 Dimensions (EQ-5D) Weighted Index Score | 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. | Baseline and 3, 6, 9, 12, 15, 18, 21, 24 and 27 Months post chemotherapy |
| Quality of Life as Assessed by the Euro-Quality of Life-5 Dimensions (EQ-5D) Crosswalk Index Score | 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. | 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 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 |
| Wexham Park Hospital; Oncology |
| Berkshire |
| SL2 4HL |
| United Kingdom |
| Queen Elizabeth Hospital | Birmingham | B15 2TH | United Kingdom |
| Birmingham Heartlands Hospital; Dept of Oncology | Birmingham | B9 5SS | United Kingdom |
| Bishop Auckland Hospital;Oncology Department | Bishop Auckland | DL14 6AD | United Kingdom |
| University Hospital of North Staffordhire | Blackpool | FY3 8NR | United Kingdom |
| Bradford Royal Infirmary; Dept of Medical Oncology C/O Ward15 | Bradford | BD9 6RJ | United Kingdom |
| Bristol Haematology and Oncology Centre | Bristol | BS2 8ED | United Kingdom |
| West Suffolk Hospital Nhs Trust; Gi Corridor | Bury St Edmunds | IP33 2QZ | United Kingdom |
| Kent & Canterbury Hospital | Canterbury | CT1 3NG | United Kingdom |
| Cumberland Infirmary; Oncology Department | Carlisle | CA2 7HY | United Kingdom |
| Broomfield Hospital; Oncology | Chelsmford | CM1 7ET | United Kingdom |
| University Hospital North Tees | Cleveland | TS19 8PE | United Kingdom |
| Castle Hill Hospital; Academic Oncology | Cottingham | HU16 5JQ | United Kingdom |
| Darlington Memorial Hospital | Darlington | DL3 6HX | United Kingdom |
| Russells Hall Hospital; Dept of Hematology | Dudley | DY1 2HQ | United Kingdom |
| University Hospital of North Durham; Oncology | Durham | DH15TW | United Kingdom |
| Harrogate Hospital | Harrogate | HG2 8AY | United Kingdom |
| Northhwick Park Hospital;Oncology Department | Harrow | HA1 3UJ | United Kingdom |
| Ipswich Hospital; Oncology Pharmacy | Ipswich | IP4 5PD | United Kingdom |
| Kidderminster Hospital; Oncology Dept | Kidderminster | DY11 6RJ | United Kingdom |
| Royal Free Hospital; Dept of Oncology | London | NW3 2QG | United Kingdom |
| Guys Hosp./Med. Onc./3rd Fl. T; Clinical Trial Office | London | SE1 9RT | United Kingdom |
| Queen Elizabeth Hospital | London | SE18 4QH | United Kingdom |
| Macclesfield District General Hospital | Macclesfield | SK10 3BL | United Kingdom |
| Maidstone & Tonbridge Wells Hospital; Kent Oncology Center | Maidstone | ME16 9QQ | United Kingdom |
| The James Cook University Hospital | Middlesbrough | TS4 3BW | United Kingdom |
| Freeman Hospital | Newcastle upon Tyne | NE7 7DN | United Kingdom |
| North Tyneside General Hospital | North Shields | NE29 8NH | United Kingdom |
| Mount Vernon Cancer Centre | Northwood | HA6 2RN | United Kingdom |
| Nottingham University Hospitals City Campus | Nottingham | NG5 1PB | United Kingdom |
| Peterborough City Hospital, Edith Cavell Campus; Oncology Department | Peterborough | PE3 9GZ | United Kingdom |
| Derriford Hospital; Gastroenterology | Plymouth | PL6 8DH | United Kingdom |
| Queen's Hospital | Romford | RM7 0AG | United Kingdom |
| Scunthorpe General Hospital; Dept of Oncology | Scunthorpe | DN16 7BH | United Kingdom |
| Stafford Hospital; Oncology Department | Stafford | ST16 3SA | United Kingdom |
| The Royal Marsden Hospital | Sutton | SM2 5PT | United Kingdom |
| Great Western Hospital, Swindon Cancer Research Unit; Osprey Unit Level 3 | Swindon | SN3 6BB | United Kingdom |
| Torbay Hospital; Oncology | Torquay | TQ2 7AA | United Kingdom |
| Royal Cornwall Hospital; Dept of Clinical Oncology | Truro | TR1 3LJ | United Kingdom |
| Walsall Manor Hospital | Walsall | WS2 9PS | United Kingdom |
| Royal Hampshire County Hospital; Winchester & Andover Breast Unit | Winchester | SO22 5DG | United Kingdom |
| The Royal Wolverhampton Hospitals NHS Trust | Wolverhampton | WV10 0QP | United Kingdom |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
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| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| C519688 | XELOX |
| D005472 | Fluorouracil |
| D000069287 | Capecitabine |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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