Unresectable pancreatic cancer patients with germline BRCA pathogenic variant
Conditions
Interventions
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.
Sponsors
Ioka Tatsuya
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) 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.
Exclusion criteria
Exclusion criteria: 1) 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 16 week progression-free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-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 | — |
Contacts
Public ContactHiroyuki Okuyama
Kagawa University Hospital
Outcome results
None listed