protocolSection identificationModule nctId: NCT06272162, orgStudyIdInfo id: NL85622.041.24, secondaryIdInfos id: 15030, type: OTHER_GRANT, domain: KWF, secondaryIdInfos id: 23U-0725, type: OTHER, domain: NedMec, briefTitle: Locally Advanced Pancreatic Cancer After Systemic Therapy: Ablative MR-guided Radiotherapy, acronym: LAPSTAR, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-02, primaryCompletionDateStruct date: 2030-01, completionDateStruct date: 2030-01, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-02-22, sponsorCollaboratorsModule leadSponsor name: UMC Utrecht, class: OTHER, collaborators name: Amsterdam UMC, location VUmc, collaborators name: Radboud University Medical Center, collaborators name: Catharina Ziekenhuis Eindhoven, collaborators name: Centre for Human Drug Research, Netherlands, collaborators name: Dutch Pancreatic Cancer Group (DPCG), descriptionModule briefSummary: A randomized controlled trial comparing the effect of local ablative MR-guided radiotherapy (MRgRT) after systemic therapy with current standard treatment alone, on health-related quality of life in patients with locally advanced pancreatic cancer (LAPC)., conditionsModule conditions: Locally Advanced Pancreatic Adenocarcinoma, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: RCT, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 150, type: ESTIMATED, armsInterventionsModule interventions name: MR guided radiotherapy, outcomesModule primaryOutcomes measure: HRQoL deterioration-free survival, secondaryOutcomes measure: Overall survival, secondaryOutcomes measure: Patient reported Quality of Life EORTC QLQ-PAN26, secondaryOutcomes measure: Patient reported Quality of Life EORTC QLQ-C30, secondaryOutcomes measure: Patient reported Quality of Life EQ5D-5L, secondaryOutcomes measure: The need of subsequent treatments, secondaryOutcomes measure: Treatment response assessed on CT-imaging (graded according to RECIST guidelines), secondaryOutcomes measure: CA 19.9 response, secondaryOutcomes measure: Trial@home monitoring related outcome: feasibility Withings Steel HR smartwatch, secondaryOutcomes measure: Trial@home monitoring related outcome: feasibility Body+ scale, secondaryOutcomes measure: Trial@home monitoring related outcome: feasibility Whitings Sleep, secondaryOutcomes measure: Trial@home monitoring related outcome: feasibility ePRO application, secondaryOutcomes measure: Trial@home monitoring related outcome: digital biomarkers, secondaryOutcomes measure: Intervention arm related outcome toxicity, secondaryOutcomes measure: Intervention arm related outcome, completion of therapy, secondaryOutcomes measure: Intervention arm related outcome diffusion weighted images, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Catharina Hospital, city: Eindhoven, state: Noord- Brabant, zip: 5623 EJ, country: Netherlands, contacts name: J. C.M. Scheepens, MD, role: CONTACT, email: j.c.m.scheepens-7@umcutrecht.nl, contacts name: H. M.U. Peulen, MD, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 51.44083, lon: 5.47778, locations facility: Amsterdam University Medical Center, VUmc, city: Amsterdam, state: Noord-Holland, zip: 1081 HV, country: Netherlands, contacts name: J. C.M. Scheepens, MD, role: CONTACT, email: j.c.m.scheepens-7@umcutrecht.nl, contacts name: A. M.E. Bruynzeel, MD, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 52.37403, lon: 4.88969, locations facility: Radboud University Medical Center, city: Nijmegen, zip: 6525 GA, country: Netherlands, contacts name: J. C.M. Scheepens, MD, role: CONTACT, email: j.c.m.scheepens-7@umcutrecht.nl, contacts name: H. D. Heerkens, MD, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 51.8425, lon: 5.85278, locations facility: University Medical Center Utrecht, city: Utrecht, zip: 3584CX, country: Netherlands, contacts name: J. C.M. Scheepens, MD, role: CONTACT, email: j.c.m.scheepens-7@umcutrecht.nl, contacts name: L. A. Daamen, MD, PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: M. P.W. Intven, MD, PhD, role: SUB_INVESTIGATOR, geoPoint lat: 52.09083, lon: 5.12222, hasResults: False