nctId: NCT06272162 id: NL85622.041.24 id: 15030 type: OTHER_GRANT domain: KWF id: 23U-0725 type: OTHER domain: NedMec briefTitle: Locally Advanced Pancreatic Cancer After Systemic Therapy: Ablative MR-guided Radiotherapy acronym: LAPSTAR overallStatus: NOT_YET_RECRUITING date: 2024-02 date: 2030-01 date: 2030-01 date: 2024-02-22 date: 2024-02-22 name: UMC Utrecht class: OTHER name: Amsterdam UMC, location VUmc name: Radboud University Medical Center name: Catharina Ziekenhuis Eindhoven name: Centre for Human Drug Research, Netherlands name: Dutch Pancreatic Cancer Group (DPCG) 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). conditions: Locally Advanced Pancreatic Adenocarcinoma studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: RCT primaryPurpose: TREATMENT masking: NONE count: 150 type: ESTIMATED name: MR guided radiotherapy measure: HRQoL deterioration-free survival measure: Overall survival measure: Patient reported Quality of Life EORTC QLQ-PAN26 measure: Patient reported Quality of Life EORTC QLQ-C30 measure: Patient reported Quality of Life EQ5D-5L measure: The need of subsequent treatments measure: Treatment response assessed on CT-imaging (graded according to RECIST guidelines) measure: CA 19.9 response measure: Trial@home monitoring related outcome: feasibility Withings Steel HR smartwatch measure: Trial@home monitoring related outcome: feasibility Body+ scale measure: Trial@home monitoring related outcome: feasibility Whitings Sleep measure: Trial@home monitoring related outcome: feasibility ePRO application measure: Trial@home monitoring related outcome: digital biomarkers measure: Intervention arm related outcome toxicity measure: Intervention arm related outcome, completion of therapy measure: Intervention arm related outcome diffusion weighted images sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Catharina Hospital city: Eindhoven state: Noord- Brabant zip: 5623 EJ country: Netherlands name: J. C.M. Scheepens, MD role: CONTACT email: j.c.m.scheepens-7@umcutrecht.nl name: H. M.U. Peulen, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 51.44083 lon: 5.47778 facility: Amsterdam University Medical Center, VUmc city: Amsterdam state: Noord-Holland zip: 1081 HV country: Netherlands name: J. C.M. Scheepens, MD role: CONTACT email: j.c.m.scheepens-7@umcutrecht.nl name: A. M.E. Bruynzeel, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 52.37403 lon: 4.88969 facility: Radboud University Medical Center city: Nijmegen zip: 6525 GA country: Netherlands name: J. C.M. Scheepens, MD role: CONTACT email: j.c.m.scheepens-7@umcutrecht.nl name: H. D. Heerkens, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 51.8425 lon: 5.85278 facility: University Medical Center Utrecht city: Utrecht zip: 3584CX country: Netherlands name: J. C.M. Scheepens, MD role: CONTACT email: j.c.m.scheepens-7@umcutrecht.nl name: L. A. Daamen, MD, PhD role: PRINCIPAL_INVESTIGATOR name: M. P.W. Intven, MD, PhD role: SUB_INVESTIGATOR lat: 52.09083 lon: 5.12222 hasResults: False