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

Roche

Status: Completed

Conditions: Colorectal Cancer

Treatments: Drug: Fluorouracil/Folinic Acid/Irinotecan; Drug: Capecitabine/Oxaliplatin; Drug: Capecitabine; Drug: Bevacizumab; Drug: Fluorouracil/Folinic Acid/Oxaliplatin; Drug: Fluorouracil +/- Folinic Acid

Study type: Observational

Funder types: Industry

Identifiers

NCT01506167

ML27971

Details and patient eligibility

About

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.

Enrollment: 719 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

719 participants in 7 patient groups

Bevacizumab and Capecitabine/Oxaliplatin

Description:

Participants who receive bevacizumab in combination with capecitabine/oxaliplatin

Treatment:

Drug: Bevacizumab

Drug: Capecitabine/Oxaliplatin

Bevacizumab and Fluorouracil/Folinic Acid/Oxaliplatin

Description:

Participants who receive bevacizumab in combination with fluorouracil/folinic acid/oxaliplatin

Treatment:

Drug: Bevacizumab

Drug: Fluorouracil/Folinic Acid/Oxaliplatin

Bevacizumab and Capecitabine

Description:

Participants who receive bevacizumab in combination with capecitabine

Treatment:

Drug: Bevacizumab

Drug: Capecitabine

Bevacizumab and Fluorouracil/Folinic Acid/Irinotecan

Description:

Participants who receive bevacizumab in combination with fluorouracil/folinic acid/irinotecan

Treatment:

Drug: Bevacizumab

Drug: Fluorouracil/Folinic Acid/Irinotecan

Bevacizumab and Capecitabine/Irinotecan

Description:

Participants who receive bevacizumab in combination with capecitabine/irinotecan

Treatment:

Drug: Bevacizumab

Bevacizumab and Fluorouracil +/- Folinic Acid

Description:

Participants who receive bevacizumab in combination with fluorouracil +/- folinic acid

Treatment:

Drug: Bevacizumab

Drug: Fluorouracil +/- Folinic Acid

Other

Description:

Participants who receive bevacizumab in combination with other first-line chemotherapy regimens

Treatment:

Drug: Bevacizumab