Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2025-12-27 @ 11:51 PM
Study NCT ID:
NCT07132060
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-08-27
First Post:
2025-08-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
MRI-guided Dose Intensification Program Locally Advanced Pancreatic Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010190', 'term': 'Pancreatic Neoplasms'}], 'ancestors': [{'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2030-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-20', 'studyFirstSubmitDate': '2025-08-12', 'studyFirstSubmitQcDate': '2025-08-12', 'lastUpdatePostDateStruct': {'date': '2025-08-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-08-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Survival', 'timeFrame': '2-years', 'description': 'A. To achieve a 1-year survival of 85%.'}], 'secondaryOutcomes': [{'measure': 'Adverse Events', 'timeFrame': '2-years', 'description': 'To decrease grade 4-5 gastrointestinal events to less than 5%.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['MRI-guided irradiation', 'Dose escalation', 'Ultrahypofractionation'], 'conditions': ['Pancreatic Cancer']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to learn if the use of dose-escalated MRI-guided irradiation increases the rates of disease control in patients with pancreatic cancer', 'detailedDescription': 'The implementation of Magnetic Resonance Image Guided Radiotherapy (MRgRT) into a Pancreatic Cancer Intensification Program maximizes treatment objectives rates due to the better visualization and online dose-adaptation pancreatic tumor.\n\nRationale In the radiation setting, MRI provides superior soft tissue contrast compared to standard onboard X-ray imaging improving inter- and intra- observer delineation variation. MRgRT offers the opportunity to adapt the plan at each fraction to the anatomical changes seen (Henke et al., 2018). This creates a much better CTV to OAR ratio in a 50Gy/5Rx scenario.\n\nPrimary Objectives A. To achieve a 1-year survival of 85%. B. To decrease grade 4-5 gastrointestinal events to less than 5%.\n\nSecondary Objectives A. Determination of blood and urine biomarkers of treatment response and toxicity .\n\nB. Determination of radiomics biomarkers of treatment response and toxicity . C. Determination of quality of life with the EORTC QLQ-C30 Questionnaire .'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Selection criteria includes patients with unresectable and borderline resectable and medically inoperable pancreatic cancer that will receive neoadjuvant chemotherapy followed by chemoirradiation.\n* No prior radiation therapy to the target areas;\n* Karnofsky performance status \\> 70 with medical condition not contraindicating treatment with radical intent including neoadjuvant chemotherapy followed by chemoirradiation.\n* WBC equal or greater than 3500 mm\\^3; platelet count equal or greater than 135000 mm\\^3; hemoglobin equal or greater than 10 gr/L; BUN equal or less than 20; serum creatinine equal or less than 2.0.\n\nExclusion Criteria:\n\n* Inability to undergo an MRI scan'}, 'identificationModule': {'nctId': 'NCT07132060', 'briefTitle': 'MRI-guided Dose Intensification Program Locally Advanced Pancreatic Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Clinica Universidad de Navarra, Universidad de Navarra'}, 'officialTitle': 'MRI-guided Dose Intensification Program Locally Advanced Pancreatic Cancer', 'orgStudyIdInfo': {'id': '2024.174'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ultrahypofractionation Phase', 'description': 'MR-Guided Ultrahypofractionation', 'interventionNames': ['Radiation: MR-guided Irradiation']}], 'interventions': [{'name': 'MR-guided Irradiation', 'type': 'RADIATION', 'description': 'MR-guided Irradiation', 'armGroupLabels': ['Ultrahypofractionation Phase']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Beatriz Ramos Aguirre, M.S.', 'role': 'CONTACT', 'email': 'ucicec@unav.es', 'phone': '+34 948255400', 'phoneExt': '2772'}], 'overallOfficials': [{'name': 'Rafael Martínez-Monge, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clínica Universidad de Navarra'}, {'name': 'Luis Fuertes, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clínica Universidad de Navarra'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': '5-years', 'ipdSharing': 'YES', 'description': 'On request', 'accessCriteria': 'On request'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Clinica Universidad de Navarra, Universidad de Navarra', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}