[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100397233":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":30,"centralContacts":35,"locations":45,"responsibleParty":75,"collaborators":64,"id":78,"slug":79,"hasResults":80,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":84,"eligibilityCriteria":85,"healthyVolunteers":80,"sex":86,"minAge":87,"maxAge":88,"enrollmentInfo":89,"targetDuration":64,"studyType":92,"phases":93,"briefSummary":95,"conditions":96,"keywords":64,"overallStatus":48,"whyStopped":64,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":107},{"fullName":5,"class":6},"Hamilton Health Sciences Corporation","OTHER",[8],{"label":9,"type":6,"description":10,"interventionNames":11},"Single Arm Intervention","1. Chemotherapy: 6 cycles (three months) of IV combination chemotherapy with mFOLFIRINOX on day 1 followed by one week of rest (14-day cycle). Alternatively, patients will receive three months of gemcitabine \u002F nab-paclitaxel.\n2. Re-staging CT scan with Carbohydrate Antigen (CA) 19-9 serum test.\n3. Staging laparoscopy to rule out occult metastatic disease is optional based on surgeon's preference.\n\n5\\. Pancreatectomy 4 weeks following the last day of Chemotherapy as per standard of care.\n\n6\\. Adjuvant chemotherapy: as per standard of care. 7. Clinical assessment and CT scan with CA 19-9 serum test at 4-month intervals until identification of cancer recurrence.\n\n8\\. Follow up of patients after 2 years every six months for up to 5 years following the initiation of treatment will be performed off-protocol as per standard of care.",[12,13],"Drug: mFOLFIRINOX","Drug: Gemcitabine \u002F Nab-paclitaxel",[15,24],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","mFOLFIRINOX","mFOLFIRINOX, including: Oxaliplatin 85 mg\u002Fm2 IV over 2 hours, Leucovorin 400mg\u002Fm2 IV over 2 hours, Irinotecan at 150 mg\u002Fm2 IV over 90 min, 5-Fluoruracil continuous infusion of 2400 mg\u002Fm2 IV over 46h.",[9],[21,22,23],"5-FU","leucovorin","oxaliplatin",{"type":16,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"Gemcitabine \u002F Nab-paclitaxel","Both drugs are administered once weekly for three weeks (days 1, 8, 15) followed by a week of rest (28-day cycle) for 3 cycles prior to imaging. Gemcitabine: 1000 mg\u002Fm2 intravenous infusion over 30 to 40 minutes. Nab-paclitaxel: 125 mg\u002Fm2 intravenous infusion over 30 to 40 minutes.",[9],[29],"gemcitabine \u002F abraxane",[31],{"name":32,"affiliation":33,"role":34},"Leyo Ruo, MD","McMaster University","PRINCIPAL_INVESTIGATOR",[36,41],{"name":32,"role":37,"phone":38,"phoneExt":39,"email":40},"CONTACT","905-521-2100","76626","ruol@mcmaster.ca",{"name":42,"role":37,"phone":38,"phoneExt":43,"email":44},"Pablo E Serrano, MD","43872","serrano@mcmaster.ca",[46],{"facility":47,"status":48,"city":49,"state":50,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"Juravinski Hospital","RECRUITING","Hamilton","Ontario","L8V1C3","Canada","CA",{"type":55,"coordinates":56},"Point",[57,58],-79.84963,43.25011,{"lat":58,"lon":57},[61,62,63,65,67,69,71,73],{"name":32,"role":37,"phone":38,"phoneExt":39,"email":40},{"name":42,"role":37,"phone":38,"phoneExt":43,"email":44},{"name":42,"role":37,"phone":64,"phoneExt":64,"email":64},null,{"name":66,"role":37,"phone":64,"phoneExt":64,"email":64},"Brandon Meyers, MD",{"name":68,"role":37,"phone":64,"phoneExt":64,"email":64},"Christian van der Pol, MD",{"name":70,"role":37,"phone":64,"phoneExt":64,"email":64},"Tariq Aziz, MD",{"name":72,"role":37,"phone":64,"phoneExt":64,"email":64},"Sameer Parpia, PhD",{"name":74,"role":37,"phone":64,"phoneExt":64,"email":64},"Kimmen Quan, MD",{"type":34,"investigatorFullName":76,"investigatorTitle":77,"investigatorAffiliation":5,"oldNameTitle":64,"oldOrganization":64},"Pablo Serrano","Associate Professor","100397233","phase-2-pancreatic-adenocarcinoma-neoadjuvant-chemotherapy-before-surgery-100397233",false,"NCT04452461","Pancreatic Adenocarcinoma Neoadjuvant Chemotherapy Before Surgery","MFOLFIRINOX or Gemcitabine \u002F Nab-paclitaxel Followed by Pancreatectomy for Patients with Borderline Resectable Pancreatic Adenocarcinoma. a Pilot Feasibility Study.","PANCREAS","Inclusion Criteria:\n\n* 1\\. Men and women 18 years of age or older who present with biopsy proven borderline resectable pancreatic adenocarcinoma who are medically fit for surgery as per assessment by treating surgeon.\n\n  2\\. Age ≤ 79 years 3. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1 4. Normal bone marrow and organ function\n  1. Absolute neutrophil count (ANC) = or \\> 1500, platelets \\> 100K\n  2. Total bilirubin \\\u003C1.5x upper limit of normal (ULN)\n  3. Alanine transaminase (ALT), Aspartate aminotransferase (AST) \\\u003C 3 x ULN\n  4. Creatinine \\\u003C150umol\u002FL\n  5. Normal prothrombin time and international normalized ratio (INR) 5. Able to provide written informed consent\n\nExclusion Criteria:\n\n1. Proven metastatic disease (e.g. on imaging modality such as CT scan of the chest, abdomen and pelvis or MRI)\n2. Locally advanced pancreatic cancer (see definition section 3.3)\n3. Prior treatment with radiation therapy to the pancreas or associated field.\n4. Contraindications to receive chemotherapy\n5. History of cardiac disease including congestive heart failure (New York Heart Association class 2), active coronary artery disease or uncontrolled hypertension\n6. Concurrent ongoing systemic infections\n7. Illegal substance abuse, or social conditions that may interfere with patient's participation in the trial\n8. Pre-existing neuropathy\n9. Pregnant patients","ALL","18 Years","79 Years",{"count":90,"type":91},30,"ESTIMATED","INTERVENTIONAL",[94],"PHASE2","This is a single-arm, single-center feasibility trial of patients with borderline resectable pancreatic adenocarcinoma receiving chemotherapy with mFOLFIRINOX or gemcitabine \u002F nab-paclitaxel followed by pancreatectomy.",[97],"Pancreatic Adenocarcinoma","2024-10-08",{"date":100,"type":101},"2024-10-10","ACTUAL",{"date":103,"type":101},"2021-03-01",{"date":105,"type":91},"2026-05-01",{"name":5,"class":6},1]