[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100431173":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":45,"centralContacts":52,"locations":58,"responsibleParty":90,"collaborators":92,"id":95,"slug":96,"hasResults":97,"nctId":98,"briefTitle":99,"officialTitle":99,"acronym":100,"eligibilityCriteria":101,"healthyVolunteers":97,"sex":102,"minAge":103,"maxAge":24,"enrollmentInfo":104,"targetDuration":24,"studyType":107,"phases":108,"briefSummary":110,"conditions":111,"keywords":114,"overallStatus":60,"whyStopped":24,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":126},{"fullName":5,"class":6},"EBG MedAustron GmbH","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Preoperative, proton- radiotherapy combined with chemotherapy","OTHER","Patients treated with three cycles of chemotherapy with Nab-PACLitaxel (Abraxane®) (125 mg\u002Fm² on day 1, 8, 15; powder for making a infusion solution) and Gemcitabine (1000 mg\u002Fm² on day 1, 8, 15; powder for making a infusion solution), followed by concomitant chemotherapy with capecitabine (1.660ml\u002Fm² on 5 days per week during the radiation therapy) and proton-therapy (with simultaneous integrated boost (SIB) 50.4 Gy Relative Biological Effectiveness (RBE) and 60.2 Gy (RBE) in 28 fractions of 1.8 Gy (RBE) and 2.15 Gy (RBE) 5 days per week), followed by re-evaluation and surgery",[13,14,15,16,17],"Radiation: Proton Ions","Drug: Nab-PACLitaxel","Drug: Gemcitabine","Drug: Capecitabine","Procedure: Surgical resection of the pancreas (when feasible)",[19,25,32,36,40],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"RADIATION","Proton Ions","According to the radiation plan (between 50.4 and a maximum of 60.2 Gy) after Chemotherapy with Nab-PACLitaxel (Abraxane®) + Gemcitabine and concomitant to Capecitabine.",[9],null,{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"DRUG","Nab-PACLitaxel","Chemotherapy will be delivered upfront for three cycles (week 2-4, week 6-8 and week 10-12) with combined Nab-PACLitaxel (Abraxane®) and Gemcitabine Therapy.\n\nIt will be administered as intra venous infusion over 30 minutes.",[9],[31],"Abraxane®",{"type":26,"name":33,"description":34,"armGroupLabels":35,"otherNames":24},"Gemcitabine","Chemotherapy will be delivered upfront for three cycles (week 2-4, week 6-8 and week 10-12) with combined Nab-PACLitaxel (Abraxane®) and Gemcitabine Therapy.\n\nGemcitabine will also be administered as intra venous infusion over 30 minutes immediately after Nab-PACLitaxel.",[9],{"type":26,"name":37,"description":38,"armGroupLabels":39,"otherNames":24},"Capecitabine","Concomitant to proton-radiotherapy (on the same days, within week 14-19)",[9],{"type":41,"name":42,"description":43,"armGroupLabels":44,"otherNames":24},"PROCEDURE","Surgical resection of the pancreas (when feasible)","Pre surgical re-evaluation will be performed at week 21 after enrollment. Patients fulfilling surgery-entry criteria, which consist of no distant metastasis, no massive ascites, no massive pleural effusion, no serious infection, no serious, unresolved chemoradiotherapy related, adverse events and adequate organ system function, will undergo surgery on week 22 (± 1 week). This should be performed via laparotomy.",[9],[46,49],{"name":47,"affiliation":5,"role":48},"Piero Fossati, M.D.","PRINCIPAL_INVESTIGATOR",{"name":50,"affiliation":51,"role":48},"Friedrich Längle, Prim., Univ. Doz., M.D.","LK Wiener Neustadt, Department of Surgery",[53],{"name":47,"role":54,"phone":55,"phoneExt":56,"email":57},"CONTACT","+43 664 80878","408","piero.fossati@medaustron.at",[59,76],{"facility":5,"status":60,"city":61,"state":62,"zip":63,"country":64,"countryCode":65,"cosmosGeoPoint":66,"geoPoint":71,"contacts":72},"RECRUITING","Wiener Neustadt","Lower Austria","2700","Austria","AT",{"type":67,"coordinates":68},"Point",[69,70],16.23196,47.80485,{"lat":70,"lon":69},[73,75],{"name":47,"role":54,"phone":74,"phoneExt":56,"email":57},"+43 2622 26 100",{"name":47,"role":48,"phone":24,"phoneExt":24,"email":24},{"facility":77,"status":60,"city":61,"state":24,"zip":63,"country":64,"countryCode":65,"cosmosGeoPoint":78,"geoPoint":80,"contacts":81},"Department of Surgery, LK Wiener Neustadt",{"type":67,"coordinates":79},[69,70],{"lat":70,"lon":69},[82,86,87],{"name":50,"role":54,"phone":83,"phoneExt":84,"email":85},"+43 2622 9004","2484","friedrich.laengle@wienerneustadt.lknoe.at",{"name":50,"role":48,"phone":24,"phoneExt":24,"email":24},{"name":88,"role":89,"phone":24,"phoneExt":24,"email":24},"Birgit Grünberger, Prim., Priv. Doz., M.D.","SUB_INVESTIGATOR",{"type":91,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR",[93],{"name":94,"class":10},"Landesklinkum Wiener Neustadt","100431173","preoperative-proton--radiotherapy-combined-with-chemotherapy-for-borderline-resectable-pancreatic-cancer-100431173",false,"NCT04894643","Preoperative, Proton- Radiotherapy Combined With Chemotherapy for Borderline Resectable Pancreatic Cancer","PARC","Inclusion Criteria:\n\n* Patients with histologically or cytologically confirmed diagnosis of pancreatic cancer\n* Diagnosis of borderline resectable cancer according to the international consensus definition 2017.\n* Negative staging for distant metastasis\n* Blood test within the following limits absolute neutrophil count \\> 1,500 cells\u002Fmm³, platelet count \\> 100,000 cells\u002Fmm³, Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) \\\u003C 2.5 times the upper limit of normal, total bilirubin \\\u003C 2.5 times the upper limit of normal if patient had recent biliary stenting, total bilirubin \\\u003C 1.5 times the upper limit of normal if no biliary stenting was done, serum creatinine within normal range (0.6-1.5 mg\u002Fdl) with a creatinine clearance \\> 30 ml\u002Fmin (as estimated by Cockroft Gault equation)\n* Age \\> 18 years\n* Karnofsky index ≥ 70\n* No tumor infiltration of stomach or duodenum\n* The patient is informed of the diagnosis and is able to give informed consent (Ability of subject to understand character and individual consequences of the study protocol)\n* Women of fertile age must have adequate conception prevention measures and must not breast feed\n* Signed Informed Consent (must be available before study inclusion)\n\nExclusion Criteria:\n\n* Non-exocrine tumors\n* Major medical or psychiatric comorbidities that contraindicate radiation therapy, chemotherapy or surgery\n* Presence of distant metastasis\n* Pregnancy or unwilling to do adequate conception prevention\n* Lactating and unwilling to discontinue lactation\n* Men of childbearing potential not willing to use effective means of contraception\n* Known allergic\u002Fhypersensitivity reaction to any of the components of study treatments\n* Previous diagnosis of another neoplasm with worse prognosis as compared with the one in this study\n* Metallic prosthesis or other condition that prevent an adequate imaging for target volume definition\n* Loco-regional conditions that contraindicate radiotherapy e.g. active infections in the area\n* Previous abdominal radiotherapy\n* Prior systemic treatment for pancreatic cancer\n* Hypersensitivity to PACLitaxel, albumin, gemcitabine or to any of the excipients of the chemotherapy\n* Severe hepatic impairment\n* Baseline Neutrophil Counts \\\u003C 1.5 x 10\\^9\u002FL\n* Baseline Grade ≥ 2 sensory or motor neuropathy\n* Patient refusal","ALL","18 Years",{"count":105,"type":106},10,"ESTIMATED","INTERVENTIONAL",[109],"NA","This is an interventional, single arm, open-label, feasibility trial with gemcitabine and nab-paclitaxel, followed by concomitant proton therapy and capecitabine, followed by re-evaluation and surgery (when feasible) for patients with borderline resectable pancreatic cancer.",[112,113],"Pancreatic Cancer","Proton Therapy",[115,116],"Proton therapy combined with chemotherapy","Borderline Resectable Pancreatic Cancer","2026-03-19",{"date":119,"type":120},"2026-03-20","ACTUAL",{"date":122,"type":120},"2020-09-14",{"date":124,"type":106},"2027-12-31",{"name":5,"class":6},2]