NIPH Clinical Trials Search

JRCT ID: jRCT1061230031

Registered date:29/06/2023

Phase II study of FOLFOX for unresectable pancreatic cancer patients with germline BRCA pathogenic variant

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedUnresectable pancreatic cancer patients with germline BRCA pathogenic variant
Date of first enrollment31/05/2023
Target sample size33
Countries of recruitment
Study typeInterventional
Intervention(s)Chemotherapy with oxaliplatin (85mg/m2, day1), levofolinate (200mg/m2, day1), 5-FU (bolus) (400mg/m2, day1), and 5-FU (46hr) (2400mg/m2, day1-3) repeated every 2 weeks.


Primary Outcome16 week progression-free survival
Secondary OutcomeProgression-free survival, overall survival, response rate, disease control rate, adverse events, percentage of introduction of olaparib or other PARP inhibitors, response rate of olaparib, disease control rate of olaparib, progression-free survival of olaparib, overall survival of olaparib, adverse events of oraparib

Key inclusion & exclusion criteria

Age minimum>= 18age old
Age maximumNot applicable
Include criteria1) Pathologically confirmed pancreatic cancer. 2) Patients with (presumed) germline pathogenic variant of BRCA1 or BRCA2 3) Unresectable or recurrent cancer 4) Age is 18 years or older 5) ECOG performance status of 0 or 1. 6) Patients determined by their physician to be ineligible for FOLFIRINOX therapy. 7) No previous chemotherapy using platinum agents for pancreatic cancer. 8) No previous chemotherapy using PARP inhibitor. 9) Adequate organ functions. 10) Written informed consent.
Exclude criteria1) Synchronous or metachronous malignancies. 2) Central nerve system metastasis. 3) Pleural effision or ascites requiring puncture or drainage. 4) Grade 2 or higher peripheral sensory or motor neurophathy. 5) Received blood transfusions, blood products, or G-CSF within 2 weeks. 6) Chronic treatment with corticosteroids or other immunosuppressive agents. 7) Interstitial pneumonia, pulmonary fibrosis. 8) Serious co-existing illness. 9) Active infection except for viral hepatitis. 10) Pregnant or lactating women, or women of childbearing potential. 11) Psychiatric disease.

Related Information


Public contact
Name Hiroyuki Okuyama
Address 1750-1 Ikenobe, Miki-cho, Kita-gun, Kagawa, 761-0793 Japan Kagawa Japan 761-0793
Telephone +81-878985111
Affiliation Kagawa University Hospital
Scientific contact
Name Tatsuya Ioka
Address 1-1-1 Minami-Kogushi, Ube, Yamaguchi, 755-8505 Japan Yamaguchi Japan 755-8505
Telephone +81-836-22-2894
Affiliation Yamaguchi University Hospital