Phase II trial of modified FOLFIRINOX (irinotecan plus oxaliplatin and 5-fluorouracil/leucovorin) in patients with untreated metastatic pancreatic cancer

Phase II trial of modified FOLFIRINOX (irinotecan plus oxaliplatin and 5-fluorouracil/leucovorin) in patients with untreated metastatic pancreatic cancer - modified FOLFIRINOX

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000013301

Enrollment

Registered

2014-02-28

Start date

2014-02-20

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

untreated metastatic pancreatic cancer

Interventions

modified FOLFIRINOX

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Histologically or cytologically proved pancreatic adenocarcinoma or adenosquamous carcinoma Age 20-75 years ECOG Performance Status (PS) 0-1 Metastatic pancreatic cancer with measurable lesion according to RECIST ver.1.1 Meets the following criteria within 7days before enrollment absolute neutrophil count<2,000/uL, platelet count<100,000/uL, hemoglobin<9 g,/dL, white blood cell count<10,000/uL, bilirubin < ULN, AST and ALT < 2.5 X ULN, CRP<2.0mg/dl Written informed consent

Exclusion criteria

Exclusion criteria: Prior radiotherapy or chemotherapy Homotype of UGT1A1 genotype including *28/*28, *6/*6 and*6/*28 Evident pleural effusion, ascites, pericardial effusion or peritoneal metastasis on CT before enrollment Pulmonary fibrosis or interstitial pneumonia Watery stool within 3 days before enrollment Uncontrolled diabetes mellitus Any serious complication

Design outcomes

Primary

Measure	Time frame
overall survival	—

Countries

Japan

Contacts

Public ContactMasato Ozaka

Cancer Institute Hospital Department of Gastroenterology

masato.ozaka@jfcr.or.jp03-3520-0111

Outcome results

None listed

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