[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100503911":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":39,"locations":49,"responsibleParty":71,"collaborators":75,"id":86,"slug":87,"hasResults":88,"nctId":89,"briefTitle":90,"officialTitle":91,"acronym":43,"eligibilityCriteria":92,"healthyVolunteers":88,"sex":93,"minAge":94,"maxAge":43,"enrollmentInfo":95,"targetDuration":43,"studyType":98,"phases":99,"briefSummary":101,"conditions":102,"keywords":105,"overallStatus":52,"whyStopped":43,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":118},{"fullName":5,"class":6},"Aalborg University Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"A: \"Full dose single agent strategy\"","ACTIVE_COMPARATOR","Gemcitabine monotherapy, 1000 mg\u002Fm2 weekly on days 1, 8, and 15 every 4 weeks",[13],"Drug: Gemcitabine",{"label":15,"type":16,"description":17,"interventionNames":18},"B: \"Reduced dose (80%) combination-therapy strategy\"","EXPERIMENTAL","Nab-Paclitaxel: 100mg\u002Fm2 plus gemcitabine: 800 mg\u002Fm2 on day 1, 8 and 15 every 4 weeks",[13,19],"Drug: Nab paclitaxel",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Gemcitabine","Gemcitabine monotherapy, 1000 mg\u002Fm2 weekly on days 1, 8, and 15 every 4 weeks or gemcitabine: 800 mg\u002Fm2 on day 1, 8 and 15 every 4 weeks",[9,15],[27],"Gemzar",{"type":22,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"Nab paclitaxel","Nab-Paclitaxel: 100mg\u002Fm2 on day 1, 8 and 15 every 4 weeks",[15],[33],"Abraxane",[35],{"name":36,"affiliation":37,"role":38},"Morten Ladekarl, Professor","Aalborg Universitets Hospital, Department of Oncology","PRINCIPAL_INVESTIGATOR",[40,45],{"name":36,"role":41,"phone":42,"phoneExt":43,"email":44},"CONTACT","0045+61399326",null,"morten.ladekarl@rn.dk",{"name":46,"role":41,"phone":47,"phoneExt":43,"email":48},"Louise Rasmussen, PhD","0045+30226432","loskr@rn.dk",[50],{"facility":51,"status":52,"city":53,"state":43,"zip":54,"country":55,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":62,"contacts":63},"Department of Oncology, Aalborg University Hospital","RECRUITING","Aalborg","9000","Denmark","DK",{"type":58,"coordinates":59},"Point",[60,61],9.9187,57.048,{"lat":61,"lon":60},[64,67],{"name":65,"role":41,"phone":66,"phoneExt":43,"email":44},"Morten Ladekarl, MD, DMSci","+45 97660545",{"name":68,"role":41,"phone":69,"phoneExt":43,"email":70},"Anja Pagh, MD, PhD","+45 97661417","a.pagh@rn.dk",{"type":72,"investigatorFullName":73,"investigatorTitle":74,"investigatorAffiliation":5,"oldNameTitle":43,"oldOrganization":43},"SPONSOR_INVESTIGATOR","Morten Ladekarl","Professor, MD, Phd",[76,78,80,82,84],{"name":77,"class":6},"Aarhus University Hospital",{"name":79,"class":6},"Odense University Hospital",{"name":81,"class":6},"Herlev and Gentofte Hospital",{"name":83,"class":6},"Gødstrup Hospital",{"name":85,"class":6},"Vejle Hospital","100503911","phase-2-gemcitabine-versus-reduced-dose-combination-chemotherapy-in-fragile-patients-with-non-resectable-pancreatic-cancer-100503911",false,"NCT05841420","Gemcitabine Versus Reduced-dose Combination Chemotherapy in Fragile Patients with Non-resectable Pancreatic Cancer","A Randomized Phase II Study of Gemcitabine Versus Reduced-dose Combination Chemotherapy in Fragile Patients with Non-resectable Pancreatic Cancer","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Adenocarcinoma of the pancreas, histopathologically or cytologically verified\n* Non-resectable (locally advanced or metastatic) PC\n* Patients unfit or not candidate for full-dose combination chemotherapy\n* Patients eligible for full dose gemcitabine or reduced dose combination chemotherapy\n* Performance status (PS) ≤2\n* Measurable or non-measurable disease\n* Adequate hematologic function defined as absolute neutrophil count (ANC) ≥1.5 x 10\\^9\u002Fl and platelets count ≥100x10\\^9\u002Fl within 2 weeks prior to enrollment\n* Adequate organ function (bilirubin ≤1.5 x UNL (Upper Normal Limit) and eGFR (estimated Glomerular Filtration Rate) \\>50ml\u002Fmin within 2 weeks prior to enrollment\n* Toxicity of prior chemotherapy, including neurotoxicity, resolved to CTCAE \\\u003Cgrade 2\n* Oral and written informed consent must be obtained according to the local Ethics committee requirements\n* Fertile patients must use adequate contraceptives\n\nExclusion Criteria:\n\n* Patients eligible for downstaging\u002Fpreoperative chemotherapy followed by resection or local ablation or irradiation\n* Prior chemotherapy for PC (However, patients treated with adjuvant therapy with recurrence occurring more than 6 months after end of this treatment are eligible)\n* Concurrent, non-curatively treated malignant neoplasm other than pancreatic adenocarcinoma\n* Concurrent treatment with any other anti-cancer therapy\n* Pregnant or breast-feeding patients\n* Patients clearly intending to withdraw from the study if not randomized in the willing arm or patients who cannot be regularly followed up for psychological, social, familiar, or geographic reasons.\n* Other condition or therapy, which in the investigator's opinion may pose a risk to the patient or interfere with the study objectives.\n* Known allergy or intolerance to any of the drugs used in DPCG-01 (Gemcitabine, S1 or Nab-Paclitaxel)","ALL","18 Years",{"count":96,"type":97},98,"ESTIMATED","INTERVENTIONAL",[100],"PHASE2","The aim of the study is to compare the efficacy and toxicity of full-dose Gemcitabine and reduced-dose combination chemotherapy in patients with non-resectable pancreatic cancer, who are unfit for full-dose combination chemotherapy.\n\nThe patients will be equally randomized to arm A or arm B:\n\nArm A: Full-dose single agent treatment with Gemcitabine 1000 mg\u002Fm2 weekly on days 1, 8,and 15 every 4 weeks.\n\nArm B: Reduced-dose (80%) combination-treatment with Gemcitabine plus Nab-Paclitaxel (Gemcitabine: 800 mg\u002Fm2 plus Nab-Paclitaxel: 100 mg\u002Fm2 on day 1, 8 and 15 every 4 weeks)\n\nProgression-free survival, overall survival and response rate will be estimated for each group, as well as toxicity and quality of life will be prospectively registered.",[103,104],"Pancreas Cancer","Non-Resectable Pancreas Carcinoma",[106,107,108],"Fragile","Elderly","Palliative","2025-01-27",{"date":111,"type":112},"2025-01-29","ACTUAL",{"date":114,"type":112},"2023-06-12",{"date":116,"type":97},"2025-06",{"name":73,"class":6},1]