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Randomized phase III study of FOLFOX plus bevacizumab versus FOLFIRI plus bevacizumab for metastatic colorectal cancer

Randomized phase III study of FOLFOX plus bevacizumab versus FOLFIRI plus bevacizumab for metastatic colorectal cancer - Randomized phase III study of bevacizumab containing chemotherapy for metastatic colorectal cancer

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000001396
Enrollment
400
Registered
2008-09-26
Start date
2008-09-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

metastatic colorectal cancer

Interventions

FOLFOX plus bevacizumab FOLFIRI plus bevacizumab

Sponsors

West Japan Oncology Group
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.Histologically documented metastatic measurable adenocarcinoma of the colorectum with no prior chemotherapies for metastatic disease. 2.Age: >20, <75. 3.ECOG PS of 0 or 1. 4.Adequate hematologic, renal, and hepatic function as defined by required baseline laboratory parameters. 5.Written informed consent.

Exclusion criteria

Exclusion criteria: 1.Brain metastasis with symptoms. 2.Massive asites, pleural effusion or pericardial effusion. 3.Double cancer with in five years prior to enroll in this study. 4.Serious non-healing wound. 5.Major surgical procedure within 28 days prior to enroll in this study. 6.Minor surgical procedure within 14 days prior to enroll in this study. 7.Other serious concomitant disease. 8.Regular use of corticosteroid. 9.Regular use of anticoagulation therapy. 10.Peripheral neuropathy > Grade 1 at baseline. 11.Active infectious disease. 12.History of serious hypersensitivity. 13.Hepatitis B surface antigen. 14.Mental disorder. 15.Pregnant or nursing.

Design outcomes

Primary

MeasureTime frame
Progression free survival

Secondary

MeasureTime frame
Overall survival, Time to treatment failure, Response rate, R0 resection rate, Toxicity, Quality of life

Countries

Japan

Contacts

Public ContactShinichiro Nakamura

West Japan Oncology Group WJOG datacenter

datacenter@wjog.jp06-6633-7400

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026