Phase II study of modified FOLFIRINOX as neoadjuvant chemotherapy for borderline resectable pancreatic cancer and locally advanced unresectable pancreatic cancer

Phase II study of modified FOLFIRINOX as neoadjuvant chemotherapy for borderline resectable pancreatic cancer and locally advanced unresectable pancreatic cancer - Phase II study of modified FOLFIRINOX as neoadjuvant chemotherapy for borderline resectable pancreatic cancer and locally advanced unresectable pancreatic cancer

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000015707

Enrollment

Registered

2014-11-17

Start date

2014-04-01

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

borderline resectable pancreatic cancer and locally advanced unresectable pancreatic cancer

Interventions

To investigate the safety and efficacy of mFOLFIRINOX for patients with borderline resectable pancreatic cancer and locally advanced unresectable pancreatic cancer.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1). Cytologically proved pancreatic adenocarcinoma or adenosquamous carcinoma; the case thought to be invasive pancreatic duct cancer. (2). Borderline resectable pancreatic cancer or locally advanced unresectable pancreatic cancer. (3). Metastatic pancreatic cancer with measurable lesion according to RECIST ver.1.1 (4). Age 20-75 years (5). ECOG Performance Status (PS) 0-1 (6). Life expectancy of at least 12 weeks (7). 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 (8). Written informed consent

Exclusion criteria

Exclusion criteria: (1). Prior radiotherapy or chemotherapy (2). Grade 2 or greater peripheral neuropathy (3). Blood transfusion, administration of blood products, or hematopoietic (e.g., G-CSF) support within 7 days before enrollment (4). Having UGT1A1*6/*6, UGT1A1*28/*28, or UGT1A1*6/*28 gene (5). Moderate ascites (6). Intestinal pneumonitis or pulmonary fibrosis (7). Watery stool within 3 days before enrollment (8). Clinically significant heart disease (9). Active infection (HBS,HCV) (10). Uncontrolled diabetes mellitus (11). Serious complications (organ failure, or uncontrolled diabetes mellitus) (12). Serious complications (mental disorder, or central nervous system disorders) (13). Serious drug allergy (14). Active double cancer (15). Pregnancy (16). Treatment with atazanavir sulfate (17). Inappropriate for this study judged by the attending physician

Design outcomes

Primary

Measure	Time frame
R0 resection rate	—

Secondary

Measure	Time frame
resection rate, response rate, histological effect, 2-year survival, relapse free survival, feasibility, dose intensity, relative dose intensity, postoperative complication, safety	—

Countries

Japan

Contacts

Public ContactYuichi Nagakawa

Tokyo Medical University Department of Gastrointestinal and Pediatric Surgery

naga@tokyo-med.ac.jp03-3342-6111

Outcome results

None listed

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