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FOLFOX plus bevacizumab alternated with sLV5FU2 plus bevacizumab as first-line chemotherapy for patients with metastatic colorectal cancer: a feasibility study

FOLFOX plus bevacizumab alternated with sLV5FU2 plus bevacizumab as first-line chemotherapy for patients with metastatic colorectal cancer: a feasibility study - FOLFOX and bevacizumab alternated with sLV5FU2 and bevacizumab for patients with metastatic colorectal cancer

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000003673
Enrollment
20
Registered
2010-05-31
Start date
2010-04-01
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

Colorectal cancer

Interventions

Treatment consisted of modified mFOLFOX6 plus bevacizumab alternated biweekly with 5-FU/LV (simplified LV5FU2) plus bevacizumab. Treatment was administered until tumor progression, unacceptable toxici

Sponsors

University of Toyama
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Histologically confirmed adenocarcinoma of the colon and rectum 2. Unresectable or recurrent colorectal cancer 3. No prior chemotherapy 4. Previous adjuvant therapy of fluoropyrimidines is permitted if completed at least 6 months before registration. 5. ECOG performance status of 0,1 6. Life expectancy of longer than 3 months 7. Adequate organ function 8. Written informed consent

Exclusion criteria

Exclusion criteria: 1. Brain metastasis 2. Massive pleural effusion or ascites 3. Active other malignancies 4. Nonhealing wound 5. Surgical procedure within 28 days before registration 6. Severe complications(bowel obstruction, symptomatic cardiovascular disease, interstitial pneumonitis, pulmonary fibrosis, uncontrollable hepertension, uncontrollable diabetes mellitus, active peptic ulcer, bleeding diathesis) 7. History of thromboembolitic disease 8. Uncontrollable diarrhea 9. Administration of corticosteroids 10. Administration of anticoagulants 11. Peripheral neuropathy 12. Active infectious disease 13. History of severe drug hypersensitivity 14. Psychosis 15. Pregnant or breast-feeding women 16. Men of wishing fertility 17. Not appropriate for the study at the physician's assessmnt

Design outcomes

Primary

MeasureTime frame
Response rate Safety

Secondary

MeasureTime frame
Progression-free survival Overall survival Time to treatment failure

Countries

Japan

Contacts

Public ContactAyumu Hosokawa

University of Toyama Department of Gastroenterology and Hematology, Faculty of Medicine

ayhosoka@med.u-toyama.ac.jp076-434-7301

Outcome results

None listed

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