Ignite Creation Date:
2025-12-26 @ 5:20 PM
Ignite Modification Date:
2025-12-31 @ 3:22 PM
Study NCT ID:
NCT06938906
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-04-24
First Post:
2025-04-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multimodal Therapy Impact on Pancreatic Cancer Survival
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 405}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2011-01-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2025-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-21', 'studyFirstSubmitDate': '2025-04-14', 'studyFirstSubmitQcDate': '2025-04-14', 'lastUpdatePostDateStruct': {'date': '2025-04-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall survival and Progression-free survival', 'timeFrame': 'From enrollment to two years after the end of treatment', 'description': 'Overall survival was calculated from the first treatment day of the disease to the day of mortality. Progression-free survival was calculated from the first treatment day of the disease to the day of proression or recurrece of pancreatic cancer.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pancreatic cancer', 'neoadjuvant chemotherapy', 'extended pancreatectomy', 'multimodal therapy', 'paradigm shift', 'survival outcomes'], 'conditions': ['Pancreatic Cancer', 'Neoadjuvant Chemotherapy', 'Pancreatectomy']}, 'descriptionModule': {'briefSummary': 'The goal of this retrospective cohort study is to analyze change of treatment strategies affect the survival outcomes in patients of pancreatic cancer who received curative-intent treatment. The main question it aims to answer is:\n\nHypothesis: Change of treatment strategies involving increased utility of neoadjuvant chemotherapy and aggressive surgical approaches of extended pancreatectomy improved the overall and progression free survival in the patients with pancreatic cancer.\n\nParticipants received curative treatment for pancreatic cancer.', 'detailedDescription': 'This study is to analyze the change of treatment strategies and shift of the paradigm over time in a single center. Researchers plan to see the impact of the evolvement to the survival outcomes in pancreatic cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with pancreatic cancer who lived in southern Taiwan.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pancreatic adenocarcinoma\n* Received curative surgery\n\nExclusion Criteria:\n\n* Other subtypes of pancreatic cancer including acinar cell carcinoma, mucinous carcinoma, undifferentiated carcinoma and intraductal papillary mucinous neoplasm with associated adenocarcinoma\n* Cases with palliative or R2 resection were also excluded from the analysis.'}, 'identificationModule': {'nctId': 'NCT06938906', 'acronym': 'MMTIPS', 'briefTitle': 'Multimodal Therapy Impact on Pancreatic Cancer Survival', 'organization': {'class': 'OTHER', 'fullName': 'National Cheng Kung University'}, 'officialTitle': 'Survival Outcome Analysis on the Strategy Shift Integrating a Multimodal Therapy of Neoadjuvant Chemotherapy and Extended Pancreatectomy in Pancreatic Cancer: A Clinical Study From a Retrospective Cohort in a Single Institute', 'orgStudyIdInfo': {'id': 'NCKUH-11405009'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group A', 'description': 'The patient of pancreatic cancer, who began to have treatment in the period between 2011 to 2017.'}, {'label': 'Group B', 'description': 'The patient of pancreatic cancer, who began to have treatment in the period between 2018 to 2022.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '704', 'city': 'Tainan', 'country': 'Taiwan', 'facility': 'National Cheng Kung University Hospital', 'geoPoint': {'lat': 22.99083, 'lon': 120.21333}}], 'overallOfficials': [{'name': 'Yan-Shen Shan, MD., PhD.', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of Surgery, National Cheng Kung University Hospital'}, {'name': 'Ting-Kai Liao, MD.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'National Cheng-Kung University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Cheng Kung University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator, Director of Specialized Ward for Division of General Surgery, Department of Surgery', 'investigatorFullName': 'Ting-Kai Liao', 'investigatorAffiliation': 'National Cheng Kung University'}}}}