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

Safety and efficacy of Alternating mFOLFOX6 and FOLFIRI every 4cycles as First line Therapy in Advanced colorectal Cancer - Safety and efficacy of Alternating mFOLFOX6 and FOLFIRI every 4cycles as First line Therapy in Advanced colorectal Cancer(KSCC0701)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000001340

Enrollment

Registered

2008-08-29

Start date

2007-07-01

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 and FOLFIRI 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.Life expectancy estimated >= 3 months 9.Sufficient organ functions 10.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. Plerral effusion, peritoneal fluid and pericardial fluid 13. Symptomatic brain metastasis 14. Water solubility diarrhea, in case of the patient who has a colostomy, diarrhea impairs daily life activity 15. Need to treatment with atazanavir sulfate 16. under coutinuous steroid therapy 17. Pregnant women, possibly pregnant women, wishing to become pregnant, and nursing mothers 18. on other clinical trial 19. Other conditions not suitable for this study

Design outcomes

Primary

Measure	Time frame
RR	—

Secondary

Measure	Time frame
Safety, PFS, 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