[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100517998":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":26,"responsibleParty":49,"collaborators":20,"id":51,"slug":52,"hasResults":53,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":20,"eligibilityCriteria":57,"healthyVolunteers":53,"sex":58,"minAge":59,"maxAge":20,"enrollmentInfo":60,"targetDuration":20,"studyType":63,"phases":64,"briefSummary":67,"conditions":68,"keywords":20,"overallStatus":29,"whyStopped":20,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":79},{"fullName":5,"class":6},"Cancer Trials Ireland","NETWORK",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Radiation; IMRT","EXPERIMENTAL","Fifteen fractions of external beam radiation therapy (EBRT) delivered via IMRT\u002F VMAT. Cohort 1 (n = 3-6) Single PTV 40.05 Gy\u002F15#, homogenous dose\\* Cohort 2 (n = 3-6) High Risk PTV 45 Gy\u002F15# SIB to PTV tumour, Elective PTV 40.05 Gy\u002F15# to nodal regions\\* Cohort 3 (n = 3-6) High risk PTV 48 Gy\u002F15# SIB to PTV tumour, Elective PTV 40.05 Gy\u002F15# to nodal regions\n\n\\* Progression to the next dose in successive cohorts depends on the number of patients experiencing DLTs within 4 weeks post-RT treatment in each patient cohort.",[13],"Radiation: Dose-Painted Intensity Modulated Radiotherapy",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"RADIATION","Dose-Painted Intensity Modulated Radiotherapy","Fifteen fractions of external beam radiation therapy (EBRT) delivered via IMRT\u002F VMAT.\n\nCohort 1 (n = 3-6) Single PTV 40.05 Gy\u002F15#, homogenous dose. Cohort 2 (n = 3-6) High Risk PTV 45 Gy\u002F15# SIB to PTV tumour, Elective PTV 40.05 Gy\u002F15# to nodal regions.\n\nCohort 3 (n = 3-6) High risk PTV 48 Gy\u002F15# SIB to PTV tumour, Elective PTV 40.05 Gy\u002F15# to nodal regions.",[9],null,[22],{"name":5,"role":23,"phone":24,"phoneExt":20,"email":25},"CONTACT","+35316677211","info@cancertrials.ie",[27,42],{"facility":28,"status":29,"city":30,"state":20,"zip":20,"country":31,"countryCode":32,"cosmosGeoPoint":33,"geoPoint":38,"contacts":39},"St Luke's Radiation Oncology Network (SLRON)","RECRUITING","Dublin","Ireland","IE",{"type":34,"coordinates":35},"Point",[36,37],-6.24889,53.33306,{"lat":37,"lon":36},[40],{"name":41,"role":23,"phone":20,"phoneExt":20,"email":20},"Dr Gerard McVey",{"facility":43,"status":29,"city":30,"state":20,"zip":20,"country":31,"countryCode":32,"cosmosGeoPoint":44,"geoPoint":46,"contacts":47},"St Vincent's University Hospital",{"type":34,"coordinates":45},[36,37],{"lat":37,"lon":36},[48],{"name":41,"role":23,"phone":20,"phoneExt":20,"email":20},{"type":50,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100517998","phase-1-dose-painted-intensity-modulated-radiotherapy-pancreas-dp-imrt-pancreas-100517998",false,"NCT06024824","Dose-Painted Intensity Modulated Radiotherapy Pancreas (DP-IMRT Pancreas)","DP-IMRT Pancreas: A Non-randomised Phase I\u002FII Study of Dose-escalated Hypofractionated Dose-Painted Intensity Modulated Radiotherapy (DPIMRT) in Resectable\u002FBorderline Resectable Pancreatic Adenocarcinoma","Inclusion Criteria\n\n1. Written informed consent obtained prior to any study-related procedures\n2. Age ≥18 years\n3. ECOG (European Cooperative Oncology Group) performance status (PS) 0-2\n4. Resectable or borderline resectable per National Comprehensive Cancer Network (NCCN) criteria (see Appendix H)\n5. Patients with histologically confirmed Pancreatic Ductal Adenocarcinoma (PDAC), with the following staging: cT1N0-2, cT2N0-2, cT3N0-2 \\[American Joint Committee on Cancer (AJCC) 8th edition\\] (see Appendix C) who are planned for pre-operative systemic chemo-radiotherapy\n6. Imaging with Computed Tomography Thorax Abdomen and Pelvis (CT TAP) and Magnetic resonance imaging (MRI) Abdomen confirms no evidence of metastatic disease\n7. Females of child-bearing potential (see Appendix G) must not be pregnant (or lactating) and must be prepared to use adequate contraception methods during treatment. Males whose female partners are of child-bearing potential must be prepared to use adequate contraception methods during treatment.\n\nExclusion Criteria\n\n1. Previous thoracic or abdominal or pelvic radiation therapy (RT)\n2. Previous treatment for bilirubin regression, other than stenting\n3. Known co-existing or prior malignancy within the last 5 years (except for Basal Cell Carcinoma (BCC) or Squamous Cell Carcinoma (SCC) of the skin) which is likely to interfere with treatment or assessment of outcomes\n4. Syndromes or conditions associated with increased radiosensitivity\n5. Uncontrolled intercurrent illness that is likely to interfere with treatment or assessment of outcomes, or psychiatric illness\u002F social situations that would limit compliance with study requirements\n6. Evidence of any other significant clinical disorder or laboratory findings that makes it undesirable for the patient to participate in the study, or if it is felt by the research\u002F Medical team that the patient may not be able to comply with the protocol and follow up schedule due to psychological, familial, sociological or geographical conditions","ALL","18 Years",{"count":61,"type":62},49,"ESTIMATED","INTERVENTIONAL",[65,66],"PHASE1","PHASE2","This is a prospective non-randomised Phase I\u002FII Radiotherapy (RT) study with patients recruited to escalated dose cohorts. Patients with resectable or borderline resectable (per the National Comprehensive Cancer Network (NCCN) criteria) pancreatic adenocarcinoma will receive dose-escalated hypofractionated DP-IMRT via Intensity Modulated Radiotherapy (IMRT) \u002F Volume Modulated Arc Therapy (VMAT).",[69],"Pancreatic Adenocarcinoma","2025-07-18",{"date":72,"type":73},"2025-07-20","ACTUAL",{"date":75,"type":73},"2024-01-30",{"date":77,"type":62},"2031-07",{"name":5,"class":6},2]