Safety and efficacy of Alternating mFOLFOX6 plus bevacizumab and FOLFIRI plus bevacizumab every 4cycles as First line Therapy in Advanced colorectal Cancer

Safety and efficacy of Alternating mFOLFOX6 plus bevacizumab and FOLFIRI plus bevacizumab every 4cycles as First line Therapy in Advanced colorectal Cancer - Safety and efficacy of Alternating mFOLFOX6 plus bevacizumab and FOLFIRI plus bevacizumab every 4cycles as First line Therapy in Advanced colorectal Cancer(KSCC0801)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000001312

Enrollment

Registered

2008-08-12

Start date

2008-03-01

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

Unresectable advanced/recurrent colorectal cancer

Interventions

Alternating mFOLFOX6 plus bevacizumab and FOLFIRI plus bevacizumab every 4cycles.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.colorectal cancer, cytologically and/or histrogically 2.Unresectable advanced/recurrent colorectal cancer 3.no prior chemotherapy 4.no prior radiotherapy 5.age: 20-75 years old 6. Performance Status(ECOG):0-2 7.with measurable lesions 8.CT/MRI within 28 days 9.Life expectancy estimated >= 3 months 10.no bleeding tendency 11.Sufficient organ functions 12.witten informed consents

Exclusion criteria

Exclusion criteria: 1. Administering antithrobotic drug within 7 days 2. Serious complications (renal failure or hepatic failure) 3. Serious drug hypersensitivity or a history of drug allergy 4. Peripheral neuropathy 5. Active concomitant malignancy 6. Active infections 7. High blood pressure and diabetic that cannot be controlled 8. symptomatic or asymptomatic but treated heart disease 9. interstitial pnumonitis, pulmonary fibrosis or high-grade pulmonary emphysema 10. histry of mental disturbances or cerebrovascular attach 11. Fresh hemorrhage from digestive tube, intestines tube paralysis, intestinal obstruction and peptic ulcer 12. Current or previous (within one year) history of GI perforation 13. Plerral effusion, peritoneal fluid and pericardial fluid 14. Symptomatic brain metastasis 15. Water solubility diarrhea, in case of the patient who has a colostomy, diarrhea impairs daily life activity 16. Need to treatment with atazanavir sulfate 17. under coutinuous steroid therapy 18. Any surgical treatments including skin-open biopsy, trauma surgery and other more intensive surgery within 4 weeks or aspiration biopsy within one week 19. CV-port procedure within one week 20. Anti-platelets therapy (including aspirin and NSAIDS) 21. history of organ transplantation 22. Traumatic gracture of unrecovery 23. Bevacizumab used previous chemotherapy 24. Pregnant women, possibly pregnant women, wishing to become pregnant, and nursing mothers 25. Other conditions not suitable for this study

Design outcomes

Primary

Measure	Time frame
PFS	—

Secondary

Measure	Time frame
Response rate, Safety, OS	—

Countries

Japan

Contacts

Public ContactKSCC

CReS KSCC

kscc2@cres-kyushu.or.jp092-631-2920

Outcome results

None listed

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