Ignite Creation Date:
2025-12-24 @ 5:39 PM
Ignite Modification Date:
2025-12-29 @ 3:02 AM
Study NCT ID:
NCT01278368
Status:
COMPLETED
Last Update Posted:
2012-12-24
First Post:
2011-01-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect Of Preoperative Chemotherapy On Short-Term Outcome After Pancreatic Resection
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': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-12', 'completionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-12-21', 'studyFirstSubmitDate': '2011-01-14', 'studyFirstSubmitQcDate': '2011-01-14', 'lastUpdatePostDateStruct': {'date': '2012-12-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-01-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative morbidity rate', 'timeFrame': 'Postoperative. From 0 to 30 days after discharge'}], 'secondaryOutcomes': [{'measure': 'Postoperative mortality', 'timeFrame': 'Postoperative. From 0 to 30 days after discharge'}, {'measure': 'Length of hospital stay (LOS)', 'timeFrame': 'Postoperative. From 0 to 30 days after discharge'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['pancreatic cancer, neoadjuvant chemotherapy'], 'conditions': ['Locally Advanced Pancreatic Adenocarcinoma']}, 'descriptionModule': {'briefSummary': 'No comparative trial investigating the effect of preoperative chemotherapy for locally advanced pancreatic cancer on short-term postoperative outcome has been published so far. The aim of the present study is to assess the potential impact of preoperative chemotherapy on short-term postoperative outcome after pancreatic resection in a case-matched series of cancer patients.', 'detailedDescription': 'Between 2003 and 2011, patients with locally advanced (stage III) pancreatic cancer who were treated with preoperative chemotherapy (PCHT) underwent surgical resection. Each patient was matched with the closest two patients with pancreatic cancer ( control group ) selected from our prospective electronic database who met the following match criteria: age (+/- 3 years), gender, ASA score, type of resection, pancreatic duct diameter (+/- 1 mm), and tumour size (+/- 5 mm).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of pancreatic cancer\n* Preoperative chemotherapy\n* Pancreatic resection\n\nExclusion Criteria:\n\n* Metastatic disease\n* ASA score 4'}, 'identificationModule': {'nctId': 'NCT01278368', 'briefTitle': 'Effect Of Preoperative Chemotherapy On Short-Term Outcome After Pancreatic Resection', 'organization': {'class': 'OTHER', 'fullName': 'Università Vita-Salute San Raffaele'}, 'officialTitle': 'PREOPERATIVE CHEMOTHERAPY DOES NOT ADVERSELY AFFECT SHORT-TERM OUTCOME AFTER PANCREATIC RESECTION.', 'orgStudyIdInfo': {'id': 'NEOADJUVANT_MATCH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Preoperative chemotherapy (PCHT)', 'description': 'Patients who underwent pancreatic resection after PCHT.', 'interventionNames': ['Procedure: Pancreatic resection after preoperative chemotherapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'Patient who underwent pancreatic resection without preoperative therapy', 'interventionNames': ['Procedure: Pancreatic resection']}], 'interventions': [{'name': 'Pancreatic resection after preoperative chemotherapy', 'type': 'PROCEDURE', 'description': 'Pancreatic resection after preoperative chemotherapy', 'armGroupLabels': ['Preoperative chemotherapy (PCHT)']}, {'name': 'Pancreatic resection', 'type': 'PROCEDURE', 'description': 'Pancreatic resection', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20132', 'city': 'Milan', 'state': 'Milan', 'country': 'Italy', 'facility': 'San Raffaele Hospital', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}], 'overallOfficials': [{'name': 'Marco Braga, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Università Vita-Salute San Raffaele'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Università Vita-Salute San Raffaele', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Surgery', 'investigatorFullName': 'Marco Braga', 'investigatorAffiliation': 'Università Vita-Salute San Raffaele'}}}}