None listed
Conditions
Interventions
Drug : 1) Subjects who meet the selection/exclusion criteria for this study will be assigned to both groups as a group A and B in turn, with patients receiving prophylactic neulapeg and those not rece
Sponsors
Yonsei University Health System, Severance Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Histologically or cytologically confirmed pancreatic cancer. 2) Patients with pancreatic cancer evaluated as locally advanced or metstatic by imaging test including CT or MRI 3)Patient planning to undergo mFOLFRINOX chemotherapy (less than secondary regimen as paaliative care) 4)Patients with ECOG activity index of 0-1 5)Patients 19 years of age or older who are willing and able to complete a written subject consent form for this trial.6)Patients with evaluable lesions according to RECIST 1.1 7)Patients Patients with adequate organ function. 8)12-lead electrocardiogram (ECG) with clinically insignificant changes that are normal or do not require medical intervention.9) Patients who do not have active infection and are judged to be eligible to participate in the study in consideration of comorbidities 10) Patients with adequate bile drainage with obstructive jaundice. 11) Patients who voluntarily agreed to participate in the study12) Women of childbearing potential are those who have a negative pregnancy test in urine or serological tests or who consent to the use of an appropriate contraceptive method
Exclusion criteria
Exclusion criteria: 1) Histologic diagnosis other than pancreatic ductal adenocarcinoma (eg, neuroendocrine tumor, etc.) 2) Patients with moderate acute or chronic medical conditions or abnormal findings on examination, which are judged to affect the results of this study 3) Patients who have participated in a study in which investigational drugs are used and are currently receiving investigational drugs or have used investigational drugs or medical devices for clinical trials within 4 weeks prior to the first administration of this investigational drug 4) Those who have received chemotherapy, targeted small molecule agents, or radiotherapy within 2 weeks prior to Day 1 of the study, or have not yet recovered (grade 1 or lower or baseline level) from adverse reactions due to previously administered drugs patient 5) Patients whose exacerbation has progressed within the past 3 years or other malignant tumors requiring active treatment are known 6) Pregnant or breastfeeding women 7) Patients who have previously received chemotherapy, radiation therapy, or surgery for pancreatic cancer8) A history of disease, treatment, or laboratory abnormalities that, in the opinion of the investigator in charge, may cause confusion in the clinical trial results, interfere with the patient's participation in the entire clinical trial, or that participation in the clinical trial itself is not in the best interest of the patient; Patients with current evidence 9) Patients with known psychiatric disorders or substance abuse disorders that may interfere with compliance with clinical trial requirements 10) Patients with a 2-year-old plan during the scheduled clinical trial period from the screening visit to the 120th day after the last dose of study drug 11) Patients who received a live vaccine within 30 days prior to the expected date of initial administration of this study drug. Note: The seasonal flu vaccine is usually an inactivated flu vaccine and is acceptable. However, intranasal influenza vaccines (eg Flu-Mist®) are not permitted as they are live attenuated vaccines. 12) Unresolved systemic active infection 13) Patients with a history of hypersensitivity or serious side effects to 5-FU, leucovorin, oxaliplatin, or irinotecan 14) Patients with contraindications to the use of 5-FU, leucovorin, oxaliplatin, or irinotecan
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Occurrence of grade 3-4 neutropenia (grade 3-4 neutropenia, ANC<1000/mL);occurrence of neutropenic fever (febrile neutropenia) | — |
Secondary
| Measure | Time frame |
|---|---|
| relative dose intensity;Quality of life evaluated according to EORTC QLQ-C30;Adverse event according to CTCAE v5.0;objective response rate;disease progression-free survival;overall survival;analysis of plasma and blood cytokine concentrations;G-CSF induced bone pain pattern evaluated by questionnaire | — |
Countries
Korea, Republic of
Contacts
Public ContactChoong-kun Lee
Yonsei University Health System, Severance Hospital
Outcome results
None listed