Clinical Trial Protocol Registry

Trial information

An Observational Study of Avastin (Bevacizumab) in Patients With Metastatic Colorectal Cancer (ACORN)

Status:
Recruiting
Protocol number:
ML27971
Sponsor:
Hoffmann-La Roche
Company division:
Pharmaceutical
Official Scientific Title:
An Observational Study of Avastin® (bevacizumab) in Combination with Chemotherapy for Treatment of First-line Metastatic Colorectal Adenocarcinoma
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. Target sample size is 1000.
Study phase:
IV
Study type:
Observational study
Conditions:
  • Colorectal Cancer
Primary outcome:
  1. Safety (incidence of serious adverse events) Time frame: 1.5 years
  2. Safety (incidence of Grade3-5 Avastin related events) Time frame: 1.5 years
  3. Progression-free survival Time frame: 1.5 years
  4. Duration of survival Time frame: 1.5 years
Key secondary outcomes:
  1. Safety (incidence of Avastin related adverse of special interest) Time frame: 1.5 years
  2. Type of treatment regimen Time frame: 1.5 years
  3. Reason for treatment discontinuation Time frame: 1.5 years
  4. Difference of patient demographics in this trial and in other studies Time frame: 1.5 years
  5. Treatment compliance Time frame: 1.5 years
  6. Treatment regimen for metastatic colorectal cancer after 1st line treatment with chemotherapy and Avastin Time frame: 1.5 years
  7. Quality of Life questionnaire (EQ-5D 5L) Time frame: 1.5 years
  8. Burden of Illness questionnaire Time frame: 1.5 years
Inclusion criteria:
  • Adult patients, >/= 18 years of age
  • 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
Gender:
Males or Females
Age limits:
Min: 18 years Max: N/A (No limit)
Accepts healthy volunteers:
No
Anticipated start date:
July, 2012
Trial registration date:
05.10.2011
Date last updated:
06.05.2013
This trial is being conducted at the following locations:
United Kingdom
  • BATH
  • BIRMINGHAM
  • BRISTOL
  • BURY ST EDMUNDS
  • CANTERBURY
  • CARLISLE
  • CHELSMFORD
  • DUDLEY
  • DURHAM
  • HARROW
  • IPSWICH
  • KIDDERMINSTER
  • LONDON
  • MACCLESFIELD
  • MAIDSTONE
  • NORTH SHIELDS
  • NORTHWOOD, ESSEX
  • NOTTINGHAM
  • PETERBOROUGH
  • PLYMOUTH
  • ROMFORD
  • SCUNTHORPE
  • STAFFORD
  • STOKE-ON-TRENT
  • SWINDON
  • TORQUAY
  • TRURO
  • WINCHESTER
  • WOLVERHAMPTON
UNITED KINGDOM
  • Sutton

Link to trial result

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