[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100454007":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":40,"centralContacts":44,"locations":50,"responsibleParty":68,"collaborators":24,"id":70,"slug":71,"hasResults":72,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":76,"eligibilityCriteria":77,"healthyVolunteers":72,"sex":78,"minAge":79,"maxAge":24,"enrollmentInfo":80,"targetDuration":24,"studyType":83,"phases":84,"briefSummary":86,"conditions":87,"keywords":89,"overallStatus":52,"whyStopped":24,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":101},{"fullName":5,"class":6},"EBG MedAustron GmbH","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Particle radiotherapy","OTHER","According to the radiation plan using protons or carbon ions (between 25 and a maximum of 40 Gy). Planning Target Volume 1 : 25 Gy (Relative Biological Effectiveness) in 5 fractions of 5 Gy (Relative Biological Effectiveness) Planning Target Volume 2 : A simultaneous integrated boost (SIB) will be delivered to the Planning Target Volume 2: 40 Gy (Relative Biological Effectiveness) in 5 fractions of 8 Gy (Relative Biological Effectiveness).",[13,14,15,16,17],"Radiation: Particle-therapy using protons or carbon ions","Diagnostic Test: Blood sampling","Diagnostic Test: Magnetic resonance imaging","Diagnostic Test: Computertomography","Diagnostic Test: 18-F-FluorDesoxyGlukose Positron Emission Tomography-Computer Tomography (18F-FDG-PET-CT)",[19,25,30,34,37],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"RADIATION","Particle-therapy using protons or carbon ions","According to the radiation plan (between 25 and a maximum of 40 Gy). Planning Target Volume 1 : 25 Gy (Relative Biological Effectiveness) in 5 fractions of 5 Gy (Relative Biological Effectiveness) Planning Target Volume 2 : A simultaneous integrated boost (SIB) will be delivered to the Planning Target Volume 2: 40 Gy (Relative Biological Effectiveness) in 5 fractions of 8 Gy (Relative Biological Effectiveness).",[9],null,{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":24},"DIAGNOSTIC_TEST","Blood sampling","Evaluation before treatment-start, after treatment and follow-up period.",[9],{"type":26,"name":31,"description":32,"armGroupLabels":33,"otherNames":24},"Magnetic resonance imaging","For treatment planning as well as for follow-up radiological tumor assessment.",[9],{"type":26,"name":35,"description":32,"armGroupLabels":36,"otherNames":24},"Computertomography",[9],{"type":26,"name":38,"description":32,"armGroupLabels":39,"otherNames":24},"18-F-FluorDesoxyGlukose Positron Emission Tomography-Computer Tomography (18F-FDG-PET-CT)",[9],[41],{"name":42,"affiliation":5,"role":43},"Piero Fossati, M.D.","PRINCIPAL_INVESTIGATOR",[45],{"name":42,"role":46,"phone":47,"phoneExt":48,"email":49},"CONTACT","+43 664 80878","408","piero.fossati@medaustron.at",[51],{"facility":5,"status":52,"city":53,"state":54,"zip":55,"country":56,"countryCode":57,"cosmosGeoPoint":58,"geoPoint":63,"contacts":64},"RECRUITING","Wiener Neustadt","Lower Austria","2700","Austria","AT",{"type":59,"coordinates":60},"Point",[61,62],16.23196,47.80485,{"lat":62,"lon":61},[65,67],{"name":42,"role":46,"phone":66,"phoneExt":48,"email":49},"+43 2622 26 100",{"name":42,"role":43,"phone":24,"phoneExt":24,"email":24},{"type":69,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","100454007","radiotherapy-for-locally-advanced-pancreatic-carcinomas-phase-ii-trial-100454007",false,"NCT05191940","Radiotherapy for Locally Advanced Pancreatic Carcinomas (Phase II Trial)","Phase II Trial of Hypo-fractionated Highly Conformal Radiotherapy for Locally Advanced Pancreatic Carcinomas","LAPC","Inclusion Criteria:\n\n1. The patient has histologically or cytological confirmed diagnosis of pancreatic cancer (cases with radiological findings suspicious of pancreatic cancer AND elevated CA 19-9 may be enrolled even without positive cytology)\n2. The patient is not candidate for radical surgical resection because of one or more of the following reasons:\n\n   1. the patient is staged as locally advanced and with unresectable disease according to the international consensus definition. Specific criteria are: there is involvement of portal vein\u002Fsuperior mesenteric vein with bilateral narrowing\u002Focclusion, exceeding the inferior border of the duodenum; or tumor contact\u002Finvasion of 180 or more degree of the superior mesenteric artery or of the truncus coeliacus; or tumor contact\u002Finvasion of the proper hepatic artery\u002F celiac artery; or tumor contact or invasion of the aorta.\n   2. the patient is not a candidate for radical surgery because of radiographic or biochemical (CA 19-9) progression during neoadjuvant chemotherapy despite being initially classified as resectable or borderline resectable according to the international consensus definition.\n   3. the patient is not candidate for radical surgery because of cN+ stage\n3. The patient is not candidate to (further) neoadjuvant chemotherapy because of one or more of the following reasons:\n\n   1. the patient is not fit for chemotherapy\n   2. the patient has progressed under chemotherapy\n   3. the patient has received neoadjuvant chemotherapy but is judged still not a candidate for explorative surgery.\n4. Negative staging for distant metastasis\n5. Age \\> 18 years\n6. Karnofsky index ≥ 70\n7. No tumor infiltration of stomach or duodenum\n8. The patient is informed of the diagnosis and is able to give informed consent (Ability of patient to understand character and individual consequences of the study protocol)\n9. Women of fertile age must have adequate conception prevention measures and must not breast feed\n10. Signed Informed Consent (must be available before study inclusion)\n\nExclusion Criteria:\n\n1. Non-exocrine tumors\n2. Major medical or psychiatric comorbidities that contraindicate radiotherapy\n3. Presence of distant metastasis\n4. Pregnancy or unwilling to do adequate conception prevention\n5. Lactating and unwilling to discontinue lactation\n6. Men of procreative potential not willing to use effective means of contraception\n7. Metallic prosthesis or other conditions - IF it prevents an adequate imaging for target volume definition or treatment planning at the discretion of the treating institution contraindicate radiotherapy e.g. active infections in the area\n8. Previous abdominal radiotherapy\n9. Severe hepatic or renal impairment at discretion of treating institution\n10. Patient refusal","ALL","18 Years",{"count":81,"type":82},30,"ESTIMATED","INTERVENTIONAL",[85],"NA","This is an interventional, single-arm, open-label study with high dose short course radiotherapy for patients with locally advanced pancreatic cancer.",[88],"Pancreas Cancer",[90,91],"Particle Radiotherapy","Hypofractionated radiotherapy","2026-03-19",{"date":94,"type":95},"2026-03-20","ACTUAL",{"date":97,"type":95},"2022-05-16",{"date":99,"type":82},"2028-12",{"name":5,"class":6},1]