[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT03322995":3,"trial-entities:NCT03322995":133,"trial-summary:NCT03322995":137},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":29,"primary_purpose":30,"phases":31,"enrollment_info":33,"interventions":36,"primary_outcomes":61,"secondary_outcomes":66,"sex":74,"minimum_age":75,"maximum_age":76,"healthy_volunteers":77,"eligibility_criteria":78,"std_ages":103,"locations":106,"central_contacts":125,"overall_officials":128,"references":131,"see_also_links":132},"NCT03322995","PRO00030656","Pancreatic Cancer Adaptive Neoadjuvant Chemotherapy Trial","Adaptive Modification of Neoadjuvant Therapy Based on Clinical Response in Patients With Localized Pancreatic Cancer","RECRUITING","2032-06-01","2026-01","2026-01-08","2018-06-21","Medical College of Wisconsin","OTHER",true,"This is an open-label, phase II study in patients with resectable and borderline resectable pancreas cancer.","Patients will receive standard chemotherapy and chemoradiation for pancreatic cancer. The study intervention is an adaptive approach which modifies systemic therapy based on clinical assessments of treatment response. Treatment response will be assessed by imaging (CT scan), biomarker \\[serum cancer antigen (CA)19-9\\] and performance status assessment \\[short physical performance battery (SPPB) and Center for Epidemiologic Studies Depression Scale (CES-D) evaluations\\] at the first restaging assessment.\n\nTreatment response will be categorized as:\n\n1. response;\n2. stable disease;\n3. local disease progression;\n4. metastatic disease progression.\n\nAfter the first restaging evaluation, patients who demonstrate:\n\n1. a response will be maintained on the same chemotherapy;\n2. stable disease will be changed to a defined alternative chemotherapy or molecular profile-directed therapy;\n3. local progression will receive chemoradiation;\n4. metastatic disease will be removed from the trial.\n\nPatients who complete four months of chemotherapy, will be treated with chemoradiation (50.4 Gray (Gy) in 28 fractions). In the absence of local disease progression deemed inoperable, or metastatic disease progression, patients will be offered surgical resection. Patients who did not receive four months of systemic therapy in the neoadjuvant setting will be offered four months of adjuvant therapy at the discretion of their treating physicians.",[19],"Pancreatic Cancer",[21,22,23,24,25,26,27,28],"Neoadjuvant","pancreatic adenocarcinoma","pancreas cancer","pancreatic cancer","molecular profiling","CA19-9","surgery","MCW","INTERVENTIONAL","TREATMENT",[32],"PHASE2",{"count":34,"type":35},125,"ESTIMATED",[37,48,55],{"type":38,"name":39,"description":40,"armGroupLabels":41,"otherNames":43},"DRUG","First-line Chemotherapy","The first-line therapy will be 5-fluorouracil, leucovorin, irinotecan, and oxaliplatin (FOLFIRINOX) or best available standard of care.",[42],"Restaging: Response to Treatment",[44,45,46,47],"Fluorouracil","Folinic acid","Camptosar","Eloxatin",{"type":38,"name":49,"description":50,"armGroupLabels":51,"otherNames":53},"Second-line Chemotherapy","Second line therapies will be multi-agent and contain gemcitabine. Molecular profiling data from the initial endoscopic ultrasound (EUS)\u002F fine needle aspirate (FNA) biopsy may be used at the discretion of the treating physician.",[52],"Restaging: Patients with Stable Disease",[54],"Gemzar",{"type":56,"name":57,"description":58,"armGroupLabels":59},"RADIATION","Chemoradiation","50.4 Gy in 28 fractions.",[60],"Restaging: Local Disease Progression",[62],{"measure":63,"description":64,"timeFrame":65},"Completion of all intended neoadjuvant therapy and surgical therapy","This measure is the number of subjects completing all intended neoadjuvant therapy and surgical therapy.","Five years.",[67,71],{"measure":68,"description":69,"timeFrame":70},"Overall survival","This measure is the number of subjects alive at the conclusion of the follow-up period.","Five years",{"measure":72,"description":73,"timeFrame":70},"Progression-free survival","This measure is the number of subjects achieving complete response, partial response or maintaining stable disease.","ALL","18 Years",null,false,{"inclusion":79,"exclusion":94,"raw_text":102},[80,81,82,83,84,85,86,87,88,89,90,91,92,93],"Be 18 years of age or older.","Be able to understand and provide written informed consent or have a legally authorized representative (LAR).","Have an Eastern Cooperative Group (ECOG) performance status \\\u003C 2 (please see the appendix).","Have documentation of histologically confirmed adenocarcinoma. Biopsy must have been completed prior to start of treatment; additional biopsy is not required for the study.","Have clinical stage consistent with resectable or borderline resectable adenocarcinoma of the pancreas, based on CT or MRI findings.","Have adequate organ and bone marrow function, as defined by:","total leukocytes \\>3 x10\\^3\u002FμL.","absolute neutrophil count (ANC) \\>1.5x 10\\^3\u002FμL.","hemoglobin \\>9 g\u002FdL.","platelets \\>100 x 10\\^3\u002FμL.","creatinine clearance \\>60 mL\u002Fmin or creatinine \\\u003C1.5 mg\u002FdL; bilirubin \\\u003C 2 mg\u002FdL.","aspartate transaminases (AST\u002FSGOT) and alanine transaminases (ALT\u002FSGPT) \\\u003C3 x upper limit of normal (ULN). At two weeks from biliary decompression, if the subject's serum AST\u002FALT remains greater 3x ULN, but has demonstrated a progressive decline, the subject may be enrolled into the trial and appropriate modification and dose adjustments will be made to the assigned regimen. Eligibility of subjects whose AST\u002FALT remain elevated 3x ULN, without demonstrating a downward trend, will be determined at the discretion of the trial principal investigators.","Subjects must be CA19-9 producers as defined by a pretreatment CA 19-9 \\> 35 U\u002FmL, when total bilirubin \\\u003C2 mg\u002FdL.","Female patients must be postmenopausal (absence of menses for \\> 1 year), surgically sterile, or have a negative pregnancy test and use at least one form of contraception for four weeks prior to Day 1 of the study, during study treatment and during the first four months after study treatment is discontinued. Male patients must be surgically sterile or use barrier contraception during the study and for four months after the last dose of any study drug.",[95,96,97,98,99,100,101],"Has received more than two months of FOLFIRINOX or mFOLFIRINOX chemotherapy as first-line therapy.","No documentation of a CA19-9 value when total bilirubin \\\u003C 2 prior to initiation of chemotherapy.","Has received any additional chemotherapy and\u002For radiation within three years prior to study enrollment.","Has any previous history of another malignancy (other than cured basal or squamous cell carcinoma of the skin or cured in situ carcinoma of the cervix or localized prostate cancer with normal prostate specific antigen) within three years of study enrollment.","Uncontrolled comorbidities including, but not limited to, ongoing or active serious infection, symptomatic congestive heart failure, unstable angina, unstable cardiac arrhythmias, psychiatric illness, excessive obesity (BMI \\>55) or situations that would limit compliance with the study requirements or the ability to willingly give written informed consent.","Known human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.","Pregnant or breastfeeding patients or any patient with childbearing potential not using contraception four weeks prior to treatment.","INCLUSION CRITERIA\n\n* Be 18 years of age or older.\n* Be able to understand and provide written informed consent or have a legally authorized representative (LAR).\n* Have an Eastern Cooperative Group (ECOG) performance status \\\u003C 2 (please see the appendix).\n* Have documentation of histologically confirmed adenocarcinoma. Biopsy must have been completed prior to start of treatment; additional biopsy is not required for the study.\n* Have clinical stage consistent with resectable or borderline resectable adenocarcinoma of the pancreas, based on CT or MRI findings.\n* Have adequate organ and bone marrow function, as defined by:\n\n  * total leukocytes \\>3 x10\\^3\u002FμL.\n  * absolute neutrophil count (ANC) \\>1.5x 10\\^3\u002FμL.\n  * hemoglobin \\>9 g\u002FdL.\n  * platelets \\>100 x 10\\^3\u002FμL.\n  * creatinine clearance \\>60 mL\u002Fmin or creatinine \\\u003C1.5 mg\u002FdL; bilirubin \\\u003C 2 mg\u002FdL.\n  * aspartate transaminases (AST\u002FSGOT) and alanine transaminases (ALT\u002FSGPT) \\\u003C3 x upper limit of normal (ULN). At two weeks from biliary decompression, if the subject's serum AST\u002FALT remains greater 3x ULN, but has demonstrated a progressive decline, the subject may be enrolled into the trial and appropriate modification and dose adjustments will be made to the assigned regimen. Eligibility of subjects whose AST\u002FALT remain elevated 3x ULN, without demonstrating a downward trend, will be determined at the discretion of the trial principal investigators.\n* Subjects must be CA19-9 producers as defined by a pretreatment CA 19-9 \\> 35 U\u002FmL, when total bilirubin \\\u003C2 mg\u002FdL.\n* Female patients must be postmenopausal (absence of menses for \\> 1 year), surgically sterile, or have a negative pregnancy test and use at least one form of contraception for four weeks prior to Day 1 of the study, during study treatment and during the first four months after study treatment is discontinued. Male patients must be surgically sterile or use barrier contraception during the study and for four months after the last dose of any study drug.\n\nEXCLUSION CRITERIA\n\n* Has received more than two months of FOLFIRINOX or mFOLFIRINOX chemotherapy as first-line therapy.\n* No documentation of a CA19-9 value when total bilirubin \\\u003C 2 prior to initiation of chemotherapy.\n* Has received any additional chemotherapy and\u002For radiation within three years prior to study enrollment.\n* Has any previous history of another malignancy (other than cured basal or squamous cell carcinoma of the skin or cured in situ carcinoma of the cervix or localized prostate cancer with normal prostate specific antigen) within three years of study enrollment.\n* Uncontrolled comorbidities including, but not limited to, ongoing or active serious infection, symptomatic congestive heart failure, unstable angina, unstable cardiac arrhythmias, psychiatric illness, excessive obesity (BMI \\>55) or situations that would limit compliance with the study requirements or the ability to willingly give written informed consent.\n* Known human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.\n* Pregnant or breastfeeding patients or any patient with childbearing potential not using contraception four weeks prior to treatment.",[104,105],"ADULT","OLDER_ADULT",[107],{"facility":108,"status":8,"city":109,"state":110,"zip":111,"country":112,"contacts":113,"geoPoint":122},"Froedtert & the Medical College of Wisconsin","Milwaukee","Wisconsin","53226","United States",[114,119],{"name":115,"role":116,"phone":117,"email":118},"Froedtert & the Medical College of Wisconsin Clinical Cancer Center","CONTACT","414-805-8900","cccto@mcw.edu",{"name":120,"role":121},"Kathleen Christians, MD","PRINCIPAL_INVESTIGATOR",{"lat":123,"lon":124},43.0389,-87.90647,[126],{"name":127,"role":116,"phone":117,"email":118},"Medical College of Wisconsin Clinical Cancer Center",[129],{"name":120,"affiliation":130,"role":121},"Professor",[],[],{"nct_id":4,"conditions":134,"biomarkers":136},[135],"Pancreatic Carcinoma",[],{"nct_id":4,"found":15,"summary":138,"prompt_version":148},{"design":139,"status":140,"heading":141,"summary":142,"follow_up":143,"word_count":144,"commitments":145,"compensation":146,"drugs_mentioned":147},"This is an open-label, Phase 2 study for 125 participants with resectable or borderline resectable pancreatic cancer. The treatment approach is adaptive, meaning it changes based on how your cancer responds.","completed","Adaptive Chemotherapy for Pancreatic Cancer","This study is testing an adaptive approach to treating pancreatic cancer that can be removed by surgery or is borderline resectable (meaning it's close to important blood vessels). You would receive standard chemotherapy, such as FOLFIRINOX (a combination of 5-fluorouracil, leucovorin, irinotecan, and oxaliplatin) or another standard treatment, followed by chemoradiation (radiation therapy combined with chemotherapy). The unique part of this study is that your treatment plan may change based on how your cancer responds, as measured by imaging (CT scans), a blood test called CA19-9, and your physical well-being. If your cancer responds well, you'll continue the same chemotherapy. If it's stable, you might switch to a different chemotherapy. If the cancer grows locally, you'll receive chemoradiation. If it spreads, you would leave the trial. The main goal is to see how many patients complete all planned chemotherapy and surgery. This study is open to adults aged 18 and older with confirmed pancreatic adenocarcinoma and good physical health. The study is currently unclear on its recruitment status and plans to enroll 125 participants.","The primary endpoint, completion of all intended neoadjuvant therapy and surgical therapy, will be measured at five years.",174,"You would receive chemotherapy and chemoradiation. Your treatment response will be assessed by CT scans, blood tests (CA19-9), and physical assessments (SPPB and CES-D evaluations) at the first restaging assessment.","Not stated in the trial record.",[57],"v2"]