--- title: An Observational Study of Avastin (Bevacizumab) in Patients With Metastatic Colorectal Cancer (ACORN) nct_id: NCT01506167 overall_status: COMPLETED sponsor: Hoffmann-La Roche study_type: OBSERVATIONAL primary_condition: Colorectal Cancer countries: United Kingdom canonical_url: "https://parkinsonspathways.com/agent/trials/NCT01506167.md" clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT01506167" ct_last_update_post_date: 2018-05-14 last_seen_at: "2026-05-12T07:19:19.385Z" source: ClinicalTrials.gov (mirrored, no enrichment) --- # An Observational Study of Avastin (Bevacizumab) in Patients With Metastatic Colorectal Cancer (ACORN) **Official Title:** An Observational Study of Avastin® (Bevacizumab) in Combination With Chemotherapy for Treatment of First-line Metastatic Colorectal Adenocarcinoma **NCT ID:** [NCT01506167](https://clinicaltrials.gov/study/NCT01506167) ## Key Facts - **Status:** COMPLETED - **Study Type:** OBSERVATIONAL - **Target Enrollment:** 719 - **Lead Sponsor:** Hoffmann-La Roche - **Conditions:** Colorectal Cancer - **Start Date:** 2012-07-06 - **Completion Date:** 2017-03-10 - **CT.gov Last Update:** 2018-05-14 ## 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. ## Eligibility - **Minimum age:** 18 Years - **Sex:** ALL - **Healthy Volunteers:** No ``` 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 ``` ## Arms - **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** — Participants who receive bevacizumab in combination with fluorouracil +/- folinic acid - **Other** — Participants who receive bevacizumab in combination with other first-line chemotherapy regimens ## Interventions - **Bevacizumab** (DRUG) — Bevacizumab was administered as part of standard first-line treatment - **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 ## Primary Outcomes - **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. ## 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)_ ## Locations (43) - Royal United Hospital Bath; Diabetes and Lipid Research, Wolfson Centre, Bath, United Kingdom - Wexham Park Hospital; Oncology, Berkshire, United Kingdom - Queen Elizabeth Hospital, Birmingham, United Kingdom - Birmingham Heartlands Hospital; Dept of Oncology, Birmingham, United Kingdom - Bishop Auckland Hospital;Oncology Department, Bishop Auckland, United Kingdom - University Hospital of North Staffordhire, Blackpool, United Kingdom - Bradford Royal Infirmary; Dept of Medical Oncology C/O Ward15, Bradford, United Kingdom - Bristol Haematology and Oncology Centre, Bristol, United Kingdom - West Suffolk Hospital Nhs Trust; Gi Corridor, Bury St Edmunds, United Kingdom - Kent & Canterbury Hospital, Canterbury, United Kingdom - Cumberland Infirmary; Oncology Department, Carlisle, United Kingdom - Broomfield Hospital; Oncology, Chelsmford, United Kingdom - University Hospital North Tees, Cleveland, United Kingdom - Castle Hill Hospital; Academic Oncology, Cottingham, United Kingdom - Darlington Memorial Hospital, Darlington, United Kingdom - Russells Hall Hospital; Dept of Hematology, Dudley, United Kingdom - University Hospital of North Durham; Oncology, Durham, United Kingdom - Harrogate Hospital, Harrogate, United Kingdom - Northhwick Park Hospital;Oncology Department, Harrow, 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 - Queen Elizabeth Hospital, London, United Kingdom - Macclesfield District General Hospital, Macclesfield, United Kingdom - Maidstone & Tonbridge Wells Hospital; Kent Oncology Center, Maidstone, United Kingdom - The James Cook University Hospital, Middlesbrough, United Kingdom - Freeman Hospital, Newcastle upon Tyne, United Kingdom - North Tyneside General Hospital, North Shields, United Kingdom - Mount Vernon Cancer Centre, Northwood, United Kingdom - Nottingham University Hospitals City Campus, Nottingham, United Kingdom - Peterborough City Hospital, Edith Cavell Campus; Oncology Department, Peterborough, United Kingdom - Derriford Hospital; Gastroenterology, Plymouth, United Kingdom - Queen's Hospital, Romford, United Kingdom - Scunthorpe General Hospital; Dept of Oncology, Scunthorpe, United Kingdom - Stafford Hospital; Oncology Department, Stafford, United Kingdom - The Royal Marsden Hospital, Sutton, United Kingdom - Great Western Hospital, Swindon Cancer Research Unit; Osprey Unit Level 3, Swindon, United Kingdom - Torbay Hospital; Oncology, Torquay, United Kingdom - Royal Cornwall Hospital; Dept of Clinical Oncology, Truro, United Kingdom - Walsall Manor Hospital, Walsall, United Kingdom - Royal Hampshire County Hospital; Winchester & Andover Breast Unit, Winchester, United Kingdom - The Royal Wolverhampton Hospitals NHS Trust, Wolverhampton, United Kingdom ## Recent Field Changes (last 30 days) - `status.overallStatus` — added _(2026-05-12)_ - `status.primaryCompletionDate` — added _(2026-05-12)_ - `status.completionDate` — added _(2026-05-12)_ - `status.lastUpdatePostDate` — added _(2026-05-12)_ - `design.enrollmentCount` — added _(2026-05-12)_ - `eligibility.criteria` — added _(2026-05-12)_ - `eligibility.minAge` — added _(2026-05-12)_ - `eligibility.sex` — added _(2026-05-12)_ - `locations.bradford royal infirmary; dept of medical oncology c/o ward15|bradford||united kingdom` — added _(2026-05-12)_ - `locations.bristol haematology and oncology centre|bristol||united kingdom` — added _(2026-05-12)_ - `locations.west suffolk hospital nhs trust; gi corridor|bury st edmunds||united kingdom` — added _(2026-05-12)_ - `outcomes.primary` — added _(2026-05-12)_ - `outcomes.secondary` — added _(2026-05-12)_ - `armsInterventions.arms` — added _(2026-05-12)_ - `armsInterventions.interventions` — added _(2026-05-12)_ - `sponsor.lead` — added _(2026-05-12)_ - `results.hasResults` — added _(2026-05-12)_ - `locations.royal united hospital bath; diabetes and lipid research, wolfson centre|bath||united kingdom` — added _(2026-05-12)_ - `locations.wexham park hospital; oncology|berkshire||united kingdom` — added _(2026-05-12)_ - `locations.queen elizabeth hospital|birmingham||united kingdom` — added _(2026-05-12)_ - `locations.birmingham heartlands hospital; dept of oncology|birmingham||united kingdom` — added _(2026-05-12)_ - `locations.bishop auckland hospital;oncology department|bishop auckland||united kingdom` — added _(2026-05-12)_ - `locations.university hospital of north staffordhire|blackpool||united kingdom` — added _(2026-05-12)_ - `locations.kent & canterbury hospital|canterbury||united kingdom` — added _(2026-05-12)_ - `locations.cumberland infirmary; oncology department|carlisle||united kingdom` — added _(2026-05-12)_ - `locations.broomfield hospital; oncology|chelsmford||united kingdom` — added _(2026-05-12)_ - `locations.university hospital north tees|cleveland||united kingdom` — added _(2026-05-12)_ - `locations.castle hill hospital; academic oncology|cottingham||united kingdom` — added _(2026-05-12)_ - `locations.darlington memorial hospital|darlington||united kingdom` — added _(2026-05-12)_ - `locations.russells hall hospital; dept of hematology|dudley||united kingdom` — added _(2026-05-12)_ - `locations.university hospital of north durham; oncology|durham||united kingdom` — added _(2026-05-12)_ - `locations.harrogate hospital|harrogate||united kingdom` — added _(2026-05-12)_ - `locations.northhwick park hospital;oncology department|harrow||united kingdom` — added _(2026-05-12)_ - `locations.ipswich hospital; oncology pharmacy|ipswich||united kingdom` — added _(2026-05-12)_ - `locations.kidderminster hospital; oncology dept|kidderminster||united kingdom` — added _(2026-05-12)_ - `locations.royal free hospital; dept of oncology|london||united kingdom` — added _(2026-05-12)_ - `locations.guys hosp./med. onc./3rd fl. t; clinical trial office|london||united kingdom` — added _(2026-05-12)_ - `locations.queen elizabeth hospital|london||united kingdom` — added _(2026-05-12)_ - `locations.macclesfield district general hospital|macclesfield||united kingdom` — added _(2026-05-12)_ - `locations.maidstone & tonbridge wells hospital; kent oncology center|maidstone||united kingdom` — added _(2026-05-12)_ - `locations.the james cook university hospital|middlesbrough||united kingdom` — added _(2026-05-12)_ - `locations.freeman hospital|newcastle upon tyne||united kingdom` — added _(2026-05-12)_ - `locations.north tyneside general hospital|north shields||united kingdom` — added _(2026-05-12)_ - `locations.mount vernon cancer centre|northwood||united kingdom` — added _(2026-05-12)_ - `locations.nottingham university hospitals city campus|nottingham||united kingdom` — added _(2026-05-12)_ - `locations.peterborough city hospital, edith cavell campus; oncology department|peterborough||united kingdom` — added _(2026-05-12)_ - `locations.derriford hospital; gastroenterology|plymouth||united kingdom` — added _(2026-05-12)_ - `locations.queen's hospital|romford||united kingdom` — added _(2026-05-12)_ - `locations.scunthorpe general hospital; dept of oncology|scunthorpe||united kingdom` — added _(2026-05-12)_ - `locations.stafford hospital; oncology department|stafford||united kingdom` — added _(2026-05-12)_ --- *Canonical: https://parkinsonspathways.com/agent/trials/NCT01506167.md* *Source data (authoritative): https://clinicaltrials.gov/study/NCT01506167* *This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*