Colorectal CancerNCT01506167
An Observational Study of Avastin (Bevacizumab) in Patients With Metastatic Colorectal Cancer (ACORN)
An observational study of Colorectal Cancer, run by Hoffmann-La Roche at 43 sites in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Bevacizumab, Capecitabine/Oxaliplatin and Fluorouracil/Folinic Acid/Oxaliplatin
- How many people
- 719 participants
- Where
- 43 sitesUnited Kingdom
- Study dates
- 6 Jul 2012to 10 Mar 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients diagnosed with metastatic colorectal cancer
Who may be able to join
- 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
Who cannot join
- Investigational, non-standard of care first-line chemotherapy regimen for treatment of metastatic colorectal cancer
- Contraindication to Avastin
Trial locations and contacts
43 sites in 1 country.
43 sites in 1 country
United Kingdom43 sites
Royal United Hospital Bath; Diabetes and Lipid Research, Wolfson Centre
Bath, BA1 3NG
Wexham Park Hospital; Oncology
Berkshire, SL2 4HL
Queen Elizabeth Hospital
Birmingham, B15 2TH
Birmingham Heartlands Hospital; Dept of Oncology
Birmingham, B9 5SS
Bishop Auckland Hospital;Oncology Department
Bishop Auckland, DL14 6AD
University Hospital of North Staffordhire
Blackpool, FY3 8NR
Bradford Royal Infirmary; Dept of Medical Oncology C/O Ward15
Bradford, BD9 6RJ
Bristol Haematology and Oncology Centre
Bristol, BS2 8ED
West Suffolk Hospital Nhs Trust; Gi Corridor
Bury St Edmunds, IP33 2QZ
Kent & Canterbury Hospital
Canterbury, CT1 3NG
Cumberland Infirmary; Oncology Department
Carlisle, CA2 7HY
Broomfield Hospital; Oncology
Chelsmford, CM1 7ET
University Hospital North Tees
Cleveland, TS19 8PE
Castle Hill Hospital; Academic Oncology
Cottingham, HU16 5JQ
Darlington Memorial Hospital
Darlington, DL3 6HX
Russells Hall Hospital; Dept of Hematology
Dudley, DY1 2HQ
University Hospital of North Durham; Oncology
Durham, DH15TW
Harrogate Hospital
Harrogate, HG2 8AY
Northhwick Park Hospital;Oncology Department
Harrow, HA1 3UJ
Ipswich Hospital; Oncology Pharmacy
Ipswich, IP4 5PD
Kidderminster Hospital; Oncology Dept
Kidderminster, DY11 6RJ
Royal Free Hospital; Dept of Oncology
London, NW3 2QG
Guys Hosp./Med. Onc./3rd Fl. T; Clinical Trial Office
London, SE1 9RT
Queen Elizabeth Hospital
London, SE18 4QH
Macclesfield District General Hospital
Macclesfield, SK10 3BL
Maidstone & Tonbridge Wells Hospital; Kent Oncology Center
Maidstone, ME16 9QQ
The James Cook University Hospital
Middlesbrough, TS4 3BW
Freeman Hospital
Newcastle upon Tyne, NE7 7DN
North Tyneside General Hospital
North Shields, NE29 8NH
Mount Vernon Cancer Centre
Northwood, HA6 2RN
Nottingham University Hospitals City Campus
Nottingham, NG5 1PB
Peterborough City Hospital, Edith Cavell Campus; Oncology Department
Peterborough, PE3 9GZ
Derriford Hospital; Gastroenterology
Plymouth, PL6 8DH
Queen's Hospital
Romford, RM7 0AG
Scunthorpe General Hospital; Dept of Oncology
Scunthorpe, DN16 7BH
Stafford Hospital; Oncology Department
Stafford, ST16 3SA
The Royal Marsden Hospital
Sutton, SM2 5PT
Great Western Hospital, Swindon Cancer Research Unit; Osprey Unit Level 3
Swindon, SN3 6BB
Torbay Hospital; Oncology
Torquay, TQ2 7AA
Royal Cornwall Hospital; Dept of Clinical Oncology
Truro, TR1 3LJ
Walsall Manor Hospital
Walsall, WS2 9PS
Royal Hampshire County Hospital; Winchester & Andover Breast Unit
Winchester, SO22 5DG
The Royal Wolverhampton Hospitals NHS Trust
Wolverhampton, WV10 0QP
About this study
Official title: 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.
- Conditions
- Colorectal Cancer
- Being tested
- Bevacizumab, Capecitabine/Oxaliplatin, Fluorouracil/Folinic Acid/Oxaliplatin, Capecitabine, Fluorouracil/Folinic Acid/Irinotecan
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BevacizumabDrug
Also called Avastin®
Bevacizumab was administered as part of standard first-line treatment
Capecitabine/OxaliplatinDrug
Capecitabine/oxaliplatin were administered along with bevacizumab as part of standard first-line treatment
Fluorouracil/Folinic Acid/OxaliplatinDrug
Fluorouracil/folinic acid/oxaliplatin were administered along with bevacizumab as part of standard first-line treatment
CapecitabineDrug
Capecitabine was administered along with bevacizumab as part of standard first-line treatment
Fluorouracil/Folinic Acid/IrinotecanDrug
Fluorouracil/folinic acid/irinotecan were administered along with bevacizumab as part of standard first-line treatment
Fluorouracil +/- Folinic AcidDrug
Fluorouracil +/- folinic acid were administered along with bevacizumab as part of standard first-line treatment
| Study group | Role | What they receive |
|---|---|---|
| Bevacizumab and Capecitabine/Oxaliplatin | Participants who receive bevacizumab in combination with capecitabine/oxaliplatin Receives: Drug: Bevacizumab; Drug: Capecitabine/Oxaliplatin | |
| Bevacizumab and Fluorouracil/Folinic Acid/Oxaliplatin | Participants who receive bevacizumab in combination with fluorouracil/folinic acid/oxaliplatin Receives: Drug: Bevacizumab; Drug: Fluorouracil/Folinic Acid/Oxaliplatin | |
| Bevacizumab and Capecitabine | Participants who receive bevacizumab in combination with capecitabine Receives: Drug: Bevacizumab; Drug: Capecitabine | |
| Bevacizumab and Fluorouracil/Folinic Acid/Irinotecan | Participants who receive bevacizumab in combination with fluorouracil/folinic acid/irinotecan Receives: Drug: Bevacizumab; Drug: Fluorouracil/Folinic Acid/Irinotecan | |
| Bevacizumab and Capecitabine/Irinotecan | Participants who receive bevacizumab in combination with capecitabine/irinotecan Receives: Drug: Bevacizumab | |
| Bevacizumab and Fluorouracil +/- Folinic Acid | Participants who receive bevacizumab in combination with fluorouracil +/- folinic acid Receives: Drug: Bevacizumab; Drug: Fluorouracil +/- Folinic Acid | |
| Other | Participants who receive bevacizumab in combination with other first-line chemotherapy regimens Receives: Drug: Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 1.5 years
Secondary outcomes (28)
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.
Measured: 1.5 years
Reasons for Discontinuation of Avastin
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline
Weeks of Further Treatment After 1st Line Chemotherapy
Number of weeks of further chemotherapy regimen administered after 1st line treatment.
Measured: 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.
Measured: 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.
Measured: 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?
Measured: 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?
Measured: 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?
Measured: 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?
Measured: 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?
Measured: Baseline
Response to the Burden of Illness Question: What is your employment status now?
Measured: 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?
Measured: 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?
Measured: 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?
Measured: Baseline and 3, 6, 9, 12, 15, 18, 21, 24 and 27 Months post chemotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2012 (estimated)
- Study start6 Jul 2012
- Primary completion10 Mar 2017
- Study completion10 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 719 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01506167
- Sponsor's protocol ID
- ML27971
- Status last verified
- May 2018
- First submitted
- 5 Jan 2012
- Last updated
- 14 May 2018
- Results posted
- No
- FDA-regulated drug
- No
Publications
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.
PubMed 31451367
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study of Avastin® (Bevacizumab) in Combination With Chemotherapy for Treatment of First-line Metastatic Colorectal Adenocarcinoma
- ClinicalTrials.gov ID
- NCT01506167
- Acronym / sponsor ID
- ML27971
- Conditions
- Colorectal Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 719 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 6 Jul 2012 (actual)
- Primary completion
- 10 Mar 2017 (actual)
- Study completion
- 10 Mar 2017 (actual)
- First posted
- 9 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Bevacizumab and Capecitabine/Oxaliplatin | – | Drug: Bevacizumab, Drug: Capecitabine/OxaliplatinParticipants who receive bevacizumab in combination with capecitabine/oxaliplatin |
| Bevacizumab and Fluorouracil/Folinic Acid/Oxaliplatin | – | Drug: Bevacizumab, Drug: Fluorouracil/Folinic Acid/OxaliplatinParticipants who receive bevacizumab in combination with fluorouracil/folinic acid/oxaliplatin |
| Bevacizumab and Capecitabine | – | Drug: Bevacizumab, Drug: CapecitabineParticipants who receive bevacizumab in combination with capecitabine |
| Bevacizumab and Fluorouracil/Folinic Acid/Irinotecan | – | Drug: Bevacizumab, Drug: Fluorouracil/Folinic Acid/IrinotecanParticipants who receive bevacizumab in combination with fluorouracil/folinic acid/irinotecan |
| Bevacizumab and Capecitabine/Irinotecan | – | Drug: BevacizumabParticipants who receive bevacizumab in combination with capecitabine/irinotecan |
| Bevacizumab and Fluorouracil +/- Folinic Acid | – | Drug: Bevacizumab, Drug: Fluorouracil +/- Folinic AcidParticipants who receive bevacizumab in combination with fluorouracil +/- folinic acid |
| Other | – | Drug: BevacizumabParticipants who receive bevacizumab in combination with other first-line chemotherapy regimens |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients diagnosed with metastatic colorectal cancer
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Investigational, non-standard of care first-line chemotherapy regimen for treatment of metastatic colorectal cancer
- Contraindication to Avastin
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BevacizumabAlso: Avastin®Bevacizumab was administered as part of standard first-line treatment | Drug | Bevacizumab and Capecitabine, Bevacizumab and Capecitabine/Irinotecan, Bevacizumab and Capecitabine/Oxaliplatin, Bevacizumab and Fluorouracil +/- Folinic Acid, Bevacizumab and Fluorouracil/Folinic Acid/Irinotecan, Bevacizumab and Fluorouracil/Folinic Acid/Oxaliplatin, Other |
| Capecitabine/OxaliplatinCapecitabine/oxaliplatin were administered along with bevacizumab as part of standard first-line treatment | Drug | Bevacizumab and Capecitabine/Oxaliplatin |
| Fluorouracil/Folinic Acid/OxaliplatinFluorouracil/folinic acid/oxaliplatin were administered along with bevacizumab as part of standard first-line treatment | Drug | Bevacizumab and Fluorouracil/Folinic Acid/Oxaliplatin |
| CapecitabineCapecitabine was administered along with bevacizumab as part of standard first-line treatment | Drug | Bevacizumab and Capecitabine |
| Fluorouracil/Folinic Acid/IrinotecanFluorouracil/folinic acid/irinotecan were administered along with bevacizumab as part of standard first-line treatment | Drug | Bevacizumab and Fluorouracil/Folinic Acid/Irinotecan |
| Fluorouracil +/- Folinic AcidFluorouracil +/- folinic acid were administered along with bevacizumab as part of standard first-line treatment | Drug | Bevacizumab and Fluorouracil +/- Folinic Acid |
Primary outcome
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.
28 secondary outcomes
Percentage of Participants with Avastin Related Adverse Events of Special Interest
Time frame: 1.5 years
Reasons for Discontinuation of Avastin
Time frame: 1.5 years
Median Progression Free Survival from Four Avastin Studies
Time frame: 1.5 years (ACORN)
Median Overall Survival from Four Avastin Studies
Time frame: 1.5 years (ACORN)
Percentage of Participants with Comparative AEs from Four Avastin® Studies
Time frame: 1.5 years (ACORN)
Median Age of Participants in Four Avastin® Studies
Time frame: Baseline
Percentage of Participants Over (or equal to) 75 Years of Age in Four Avastin Studies
Time frame: Baseline
Percentage of Males and Females in Four Avastin Studies
Time frame: Baseline
Eastern Cooperative Oncology Group (ECOG) Performance Status in Four Avastin Studies
Time frame: 1.5 years (ACORN)
Race/Ethnicity of Participants in Four Avastin Studies
Time frame: Baseline
Percentage of Participants at Stage IV (at diagnosis) in Four Avastin Studies
Time frame: Baseline
Percentage of Participants that Received Previous Systematic Treatment for CRC in Four Avastin Studies
Time frame: Baseline
Sites of CRC in Four Avastin Studies
Time frame: Baseline
Percentage of Participants with Primary Resection in Four Avastin Studies
Time frame: Baseline
Metastatic Sites of CRC in Four Avastin Studies
Time frame: Baseline
Ongoing Patient Medical Conditions in Four Avastin Studies
Time frame: Baseline
Weeks of Further Treatment After 1st Line Chemotherapy
Time frame: 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
Time frame: 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
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 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2018.
- Derived from this study: PubMed 31451367Khakoo 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Hoffmann-La Roche
43 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer, run by Hoffmann-La Roche at 43 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 43 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants with Serious Adverse Events (SAEs) (time frame: 1.5 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01506167, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2018.