The pilot study of neoadjuvant chemotherapy of FIRINOX for patients with borderline resectable pancreatic cancer

The pilot study of neoadjuvant chemotherapy of FIRINOX for patients with borderline resectable pancreatic cancer - FIRINOX

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000013809

Enrollment

Registered

2014-04-25

Start date

2014-04-28

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

Invasive ductal carcinoma

Interventions

neoadjuvant chemotherapy 4 courses of FIRINOX L-OHP 85mg/m2 administration CPT-11 150mg/m2 administration 5-FU 2,400mg/m2 46hours infusion neoadjuvant chemotherapy 8 courses of FIRINOX L-O

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1)Pathologically proven invasive pancreatic ductal carcinoma (2)Cases that meet the definition of borderline resectable pancreatic cancer 1) or 2) 1) Definition of a borderline resectable pancreatic cancer is filledin NCCN guideline version 1.2014 pancreatic adenocarcinoma 2) Patients indicated distal pancreatectomy with en bloc celiac axis resection (3)PS (ECOG) 0-1 (4)>=20 years old and < 75 years old (5)First line treatment (6)The following criteria must be satisfied in laboratory tests within 14 days of registration White blood cell count <=12,000/mm3 Neutrophil count >=1,500/mm3 Platelet count >=100,000mm3 Total bilirubin <2.0mg/dL Serum Creatinine <=upper limits of normal(ULN) AST,ALT<= 2.5xULN Albumin>=3.0g/dL Hemoglobin>=9.0g/dL (7)Written informed consent to participate in this study (8)Pancreatic head carcinoma without biliary drainage

Exclusion criteria

Exclusion criteria: (1)Severe drug hypersensitivity (2)Multiple primary cancers within 5 years (3)Severe infection (4)With grade 2 or more severe peripheral neuropathy (5)With intestinal paralysys, ileus (6)Interstitial pneumonia or pulmonary (7)With uncontrollable pleural effusion or ascites (8)Receiving atazanavir sulfate (9)With uncontrollable diabetes (10)With uncontrollable heart failure, angina, hypertension, arrhythmia (11)With severe psychological symptoms (12)With watery diarrhea (13)Pregnant or lactating women, or women with known or suspected pregnancy (14)Inappropriate patients for entry on this study in the judgment of the investigator (15)With UGT1A1*28 and/or UGT1A1*6 polymorphisms

Design outcomes

Primary

Measure	Time frame
(1)Adverse event	—

Secondary

Measure	Time frame
(1)R0 resection rate (2)Resection rate (3)Optimal number of courses administration of neoadjuvant chemotherapy (4)Optimal duration of surgery to perform from neoadjuvant chemotherapy	—

Countries

Japan

Contacts

Public ContactKen-ichi Okada

Wakayama Medical University Second Department of Surgery

okada@wakayama-med.ac.jp073-441-0613

Outcome results

None listed

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