protocolSection identificationModule nctId: NCT06353581, orgStudyIdInfo id: 4-2021-0924, briefTitle: Prophylactic Administration of Neulapeg (Pegteograstim) in Patients With Locally Advanced or Metastatic Pancreatic Cancer Receiving the Modified FOLFIRINOX, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2022-02-16, primaryCompletionDateStruct date: 2024-05-08, completionDateStruct date: 2024-05-08, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Yonsei University, class: OTHER, descriptionModule briefSummary: Neutropenia, a decrease in the number of neutrophils, a type of white blood cell, due to the myelosuppressive effects of chemotherapeutic drugs, is a frequent occurrence in patients receiving anticancer drug therapy, which increases the risk of infection, which can have serious consequences such as antibiotic treatment, hospitalization, intensive care unit treatment, and death, and also reduces the effectiveness of anticancer treatment due to dose reduction and cycle delay. Therefore,G-CSF,which acts as a neutrophil growth factor, can be administered immediately after chemotherapy to increase the production rate of neutrophils and promote the efflux of mature neutrophils from the bone marrow, thereby increasing the absolute neutrophil count. Guidelines for the use of G-CSF published by the NCCN indicate that primary prophylaxis with G-CSF has clinical benefit for patients receiving anticancer drug therapy with a risk of febrile neutropenia greater than 20%. For those at 10-20% risk, consider primary prophylaxis based on risk factors. The frequency of neutropenic fever with FOLFIRINOX chemotherapy, which is commonly used in patients with locally advanced or metastatic pancreatic cancer, was 5.4% in a prospective study of patients receiving high-dose regimens, but 42.5% of patients received prophylactic G-CSF, and 63.0% of patients received prophylactic G-CSF compared to 3.0% when given as postoperative adjuvant therapy demonstrating the need for G-CSF administration.In a retrospective study in Japan, a modified FOLFIRINOX chemotherapy regimen without pegylated G-CSF was associated with a 23% incidence of neutropenic fever and 61.5% grade 3-4 neutropenia, while prophylactic administration of pegylated G-CSF was associated with zero neutropenic fever and grade 3-4 neutropenia and longer survival .A retrospective study from Korea also reported that prophylactic G-CSF administration reduced neutropenic fever from 18.5% to 1.8% and Grade 3-4 neutropenia from 55.6% to 31.6 in pancreatic cancer patients receiving FOLFIRINOX .Pegteograstim (Neulapeg®) is a pegylated human recombinant granulocyte colony-stimulating factor with a long half-life (15-80 hours) compared to filgrastim (3-4 hours). Although several studies have demonstrated that G-CSF primary prophylaxis reduces the frequency of hematologic toxicities, particularly febrile neutropenia, during chemotherapy, it has not been prospectively studied whether primary prophylaxis reduces the frequency of grade 3-4 neutropenia and neutropenic fever in the modified FOLFIRINOX chemotherapy regimen in patients with pancreatic cancer. Therefore, this study is designed to determine if prophylactic administration of NEURAPEC reduces the frequency of Grade 3-4 neutropenia and neutropenic fever in patients with locally advanced or metastatic pancreatic cancer receiving modified FOLFIRINOX chemotherapy., conditionsModule conditions: Locally Advanced Pancreatic Cancer, conditions: Metastatic Pancreatic Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 78, type: ACTUAL, armsInterventionsModule interventions name: Neulapeg, interventions name: Control, outcomesModule primaryOutcomes measure: Development of grade 3-4 neutropenia (grade 3-4 neutropenia, ANC<1000/mL), primaryOutcomes measure: development of neutropenic fever (febrile neutropenia), secondaryOutcomes measure: relative dose intensity, secondaryOutcomes measure: quality of life assessed according to EORTC QLQ-C30, secondaryOutcomes measure: Number of patients experiencing Adverse events (AEs), secondaryOutcomes measure: objective response rate, secondaryOutcomes measure: Progression-free survival, secondaryOutcomes measure: Overall survival, secondaryOutcomes measure: Change in blood cytokine concentrations, secondaryOutcomes measure: G-CSF induced bone pain as assessed by questionnaires, eligibilityModule sex: ALL, minimumAge: 19 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Severance Hospital, city: Seoul, country: Korea, Republic of, geoPoint lat: 37.566, lon: 126.9784, hasResults: False