Fluorouracil/leucovorin, irinotecan and oxaliplatin (FOLFIRINOX): a phase II study in non-resectable pancreatic cancer patients.

Fluorouracil/leucovorin, irinotecan and oxaliplatin (FOLFIRINOX): a phase II study in non-resectable pancreatic cancer patients. - (FOLFIRINOX): a phase II

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000005808

Enrollment

Registered

2011-06-20

Start date

2011-06-01

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

Pancreatic cancer

Interventions

Oxaliplatin 85mg/m2 x 2hours, Leucovorin 400 mg/m2 x 2hours, Irinotecan 125 mg/m2 x 1.5hours, 5-FU 400mg/m2 x bolus, and 5-FU 2400 mg/m2 x 46hours (q2wks).

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Histologically and cytologically confirmed, measurable metastatic pancreatic adenocarcinoma. 2.18 years of age or older. 3.ECOG performance status score of 0 or 1. 4.Granulocyto count >1500 5.Platelet count > 100,000 6.bilirubin < 1.5 times the upper limit of the normal range. 7. Normal renal function

Exclusion criteria

Exclusion criteria: 1.Age of 76 years or older. 2.Endocrine or acinar pancreatic carcinoma. 3.Brain metastases. 4.Another major cancer. 5.Active infection. 6.Chronic diarrhea. 7.Cardiac disease 8.Pregnancy or breast-feeding 9.In the UGT1A1 allele, UGT1A1 (*)28/(*)28 genotype UGT1A1 (*)28/(*)6 genotype UGT1A1 (*)6/(*)6 genotype

Design outcomes

Primary

Measure	Time frame
Safety and feasibility in FOLFIRINOX.	—

Secondary

Measure	Time frame
Response rate, survival rate, progression-free survival rate,and toxicity.	—

Countries

Japan

Contacts

Public ContactYasushi Ichikawa

Yokohama City University Graduate School of Medicine Department of Clinical Oncology

045-787-2800

Outcome results

None listed

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