[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100502654":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":34,"centralContacts":39,"locations":45,"responsibleParty":64,"collaborators":66,"id":70,"slug":71,"hasResults":72,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":23,"eligibilityCriteria":76,"healthyVolunteers":72,"sex":77,"minAge":78,"maxAge":23,"enrollmentInfo":79,"targetDuration":23,"studyType":82,"phases":83,"briefSummary":85,"conditions":86,"keywords":23,"overallStatus":47,"whyStopped":23,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"fullName":5,"class":6},"Wake Forest University Health Sciences","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Neoadjuvant Chemotherapy (Gemcitabine and nab-Paclitaxel and mFOLFIRNIOX)","EXPERIMENTAL","* Gemcitabine (1000 mg\u002Fm2 weekly, on day 1,8 and 15 OR 1000 mg\u002Fm2 weekly, on day 1 and 15 over 30 minutes after nab-paclitaxel infusion.\n* nab-Paclitaxel (125 mg\u002Fm2 weekly, on days 1,8, and 15 OR on days 1 and 15 as a 30-40 minute infusion administered first) for one month and then transition to mFOLFIRNIOX for one month\n\n  1 Cycle = 4 weeks: Day 1,8,15 in a 28 day cycle; 3 consecutive weeks (weeks 1, 2, and 3) of chemotherapy with 1 week off, OR\n\n  1 Cycle = 4 weeks: Day 1, 15 in a 28 day cycle; Every other week (weeks 1 and 3) of chemotherapy with 2nd and 4th week off\n* mFOLFIRINOX: Oxaliplatin, 85 mg\u002Fm² IV once every two weeks over 2 hours on Day 1 Irinotecan, 150 mg\u002Fm² IV once every two weeks over 90 minutes on Day 1 5-FU, 2,400 mg\u002Fm² IV once every two weeks over 46-48 hours administered via infusion Leucovorin, 400 mg\u002Fm2 IV every two weeks over 90 minutes on Day 1\n\n  1. Cycle = 4 weeks, administration on Day 1 and Day 15 of each mFOLIRINOX cycle",[13,14,15,16],"Drug: Nab paclitaxel","Drug: Gemcitabine","Other: Radiological Assessments","Drug: mFOLFIRINOX",[18,24,27,31],{"type":19,"name":20,"description":21,"armGroupLabels":22,"otherNames":23},"DRUG","Nab paclitaxel","The intervention will be administered on an outpatient basis. The patients on this study will begin treatment with GA for one month and then transition to mFFX for one month.\n\nThe patient will come off of the sequence study intervention if the imaging after the 2nd month shows unequivocal progression. After four months of sequential neoadjuvant therapy the patient will come off study and can proceed to surgery, radiation, or extended course of chemotherapy as determined by the multidisciplinary tumor board consensus or the treating physician.",[9],null,{"type":19,"name":25,"description":21,"armGroupLabels":26,"otherNames":23},"Gemcitabine",[9],{"type":6,"name":28,"description":29,"armGroupLabels":30,"otherNames":23},"Radiological Assessments","CT imaging of chest abdomen and pelvis will be performed every 8 weeks. MRI may be used.",[9],{"type":19,"name":32,"description":21,"armGroupLabels":33,"otherNames":23},"mFOLFIRINOX",[9],[35],{"name":36,"affiliation":37,"role":38},"Ravi K Paluri, MD, MPH","Wake Forest Baptist Comprehensive Cancer Center","PRINCIPAL_INVESTIGATOR",[40],{"name":41,"role":42,"phone":43,"phoneExt":23,"email":44},"Study Coordinator","CONTACT","3367165772","Emily.Teal@advocatehealth.org",[46],{"facility":37,"status":47,"city":48,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"RECRUITING","Winston-Salem","North Carolina","27157","United States","US",{"type":54,"coordinates":55},"Point",[56,57],-80.24422,36.09986,{"lat":57,"lon":56},[60,63],{"name":41,"role":42,"phone":61,"phoneExt":23,"email":62},"336-713-6912","ahumbert@wakehealth.edu",{"name":36,"role":38,"phone":23,"phoneExt":23,"email":23},{"type":65,"investigatorFullName":23,"investigatorTitle":23,"investigatorAffiliation":23,"oldNameTitle":23,"oldOrganization":23},"SPONSOR",[67],{"name":68,"class":69},"National Cancer Institute (NCI)","NIH","100502654","phase-2-neoadjuvant-chemotherapy-for-borderline-resectable-and-locally-advanced-pancreatic-adenocarcinoma-100502654",false,"NCT05825066","Neoadjuvant Chemotherapy for Borderline Resectable and Locally Advanced Pancreatic Adenocarcinoma","Sequential Neoadjuvant Chemotherapy for Borderline Resectable and Locally Advanced Pancreatic Adenocarcinoma","Inclusion Criteria:\n\n* Patients must have histologically or cytologically proven adenocarcinoma of the pancreas. Patients with mixed tumor with predominant adenocarcinoma pathology can be enrolled\n* Patients with borderline resectable or locally advanced pancreatic adenocarcinoma as assessed per National Comprehensive Cancer Network (NCCN) guidelines (either pancreatic head, neck, uncinate process, or body\u002Ftail) or institutional multidisciplinary consensus\n* Age 18 or above\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 1\n* Patients must have organ and marrow function as defined below:\n\nHemoglobin\\* ≥8 g\u002FdL Absolute neutrophil count ≥1,500\u002FmcL Platelets\\* ≥100,000\u002FmcL Total bilirubin\\* ≤1.5 X institutional upper limit of normal AST(SGOT)\u002FALT(SGPT) \\\u003C2.5 X institutional upper limit of normal Creatinine ≤1.5 X institutional upper limit of normal or CrCL\\>50\n\n* It is acceptable to transfuse packed red blood cells (PRBC) and platelets at the time of enrollment to meet the eligibility criteria.\n* If obstructive jaundice is present, consider ursodiol or a biliary drainage procedure. If the total bilirubin can be reduced or kept to less than or equal to 3 mg\u002FdL, then this inclusion criteria is met.\n\n  * Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST v1.1).\n  * Ability to understand and the willingness to sign an IRB-approved informed consent document (either directly or via a legally authorized representative)\n\nExclusion Criteria:\n\n* Patients who have had prior chemotherapy with gemcitabine and\u002For nab-paclitaxel or FOLFIRINOX for pancreatic cancer\n* Patients receiving any other investigational anti-neoplastic agents\n* History of malignancy in last 3 years except cervical cancer in situ, adequately treated basal cell or squamous cell carcinoma of skin or treated low risk prostate cancer, who are considered to be eligible\n* Patients with active and uncontrolled bacterial, viral or fungal infection requiring systemic therapy. Patients can be reevaluated for the study if the infection is deemed to be under control and the systemic therapy for the infection is completed\n* Uncontrolled intercurrent illness including, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements or compromise the patient's safety\n* Patients with known diagnosis of interstitial lung disease, sarcoidosis, pulmonary fibrosis, or pneumonitis requiring oxygen supplementation. Those that do not require oxygen supplementation are eligible.\n* Patients who have undergone surgery, other than diagnostic or minor procedures, within 4 weeks prior to the initiation of study treatment\n* Patients who are pregnant or breastfeeding","ALL","18 Years",{"count":80,"type":81},64,"ESTIMATED","INTERVENTIONAL",[84],"PHASE2","The objective of this research is to find out what effects (good and bad), the sequence of Gemcitabine - Abraxane (nab-Paclitaxel) followed by mFOLFIRINOX, the standard chemotherapy for pancreatic cancer, has on participants and their condition. Gemcitabine - Abraxane (nab-Paclitaxel) and mFOLFIRINOX has been approved by the US Food and Drug Administration (FDA) as first line treatment for advanced pancreatic cancer. The sequence of Gemcitabine - Abraxane (nab-Paclitaxel) followed by mFOLFIRINOX has not been approved by the FDA for treatment of pancreatic cancer.",[87,88,89],"Pancreas Adenocarcinoma","Borderline Resectable Pancreatic Adenocarcinoma","Locally Advanced Pancreatic Adenocarcinoma","2026-03-23",{"date":92,"type":93},"2026-03-25","ACTUAL",{"date":95,"type":93},"2023-08-01",{"date":97,"type":81},"2028-07",{"name":5,"class":6},1]