Ignite Creation Date:
2025-12-24 @ 3:51 PM
Ignite Modification Date:
2026-01-01 @ 9:42 PM
Study NCT ID:
NCT05268692
Status:
RECRUITING
Last Update Posted:
2022-03-07
First Post:
2022-02-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Neoadjuvant Chemotherapy for Pancreatic Cancer Followed by GS and GnP
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2030-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-02-24', 'studyFirstSubmitDate': '2022-02-01', 'studyFirstSubmitQcDate': '2022-02-24', 'lastUpdatePostDateStruct': {'date': '2022-03-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'overall survival', 'timeFrame': '5 years', 'description': 'postoperative survival'}], 'secondaryOutcomes': [{'measure': 'adverse events', 'timeFrame': 'up to 24 weeks', 'description': 'incidence of adverse events for neoadjuvant chemotherapy for pancreatic cancer'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Neoadjuvant'], 'conditions': ['Pancreatic Adenocarcinoma']}, 'descriptionModule': {'briefSummary': 'The effect of neoadjuvant chemotherapy for pancreatic cancer was gradually established. However it has been not clarified which regimen of neoadjuvant treatment for pancreatic cancer is the best.', 'detailedDescription': 'gemcitabine plus S-1 versus gemcitabine plus nab-paclitaxel'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nelective pancreatectomy for pancreatic cancer\n\nExclusion Criteria:\n\na previous cancer surgery a body weight loss of \\>10% during the 6 months before surgery the presence of distant metastases seriously impaired function of vital organs because of respiratory, renal, or heart disease.'}, 'identificationModule': {'nctId': 'NCT05268692', 'briefTitle': 'Neoadjuvant Chemotherapy for Pancreatic Cancer Followed by GS and GnP', 'organization': {'class': 'OTHER', 'fullName': 'Kochi University'}, 'officialTitle': 'Neoadjuvant Chemotherapy for Pancreatic Cancer; GS vs. GnP', 'orgStudyIdInfo': {'id': 'GSGnP'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'GS', 'description': 'gemcitabine plus S-1', 'interventionNames': ['Drug: GS']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'GnP', 'description': 'gemcitabine plus nab-paclitaxel', 'interventionNames': ['Drug: GnP']}], 'interventions': [{'name': 'GS', 'type': 'DRUG', 'description': 'drip infusion of gemcitabine plus oral administration of S-1 S-1 received S-1 orally twice daily at a dose calculated according to body-surface area (BSA) (\\< 1.25 m2, 60 mg/d; ≥ 1.25 to \\< 1.5 m2, 80 mg/d; ≥ 1.5 m2, 100 mg/d) on days 1 through 14 of a 21-day cycle gemcitabine received gemcitabine intravenously at a dose of 800 mg/m2 over 30 minutes on days 1 and 8of a 21-day cycle.', 'armGroupLabels': ['GS']}, {'name': 'GnP', 'type': 'DRUG', 'description': 'drip infusion of both gemcitabine and nab-paclitacel gemcitabine received gemcitabine intravenously at a dose of 800 mg/m2 over 30 minutes on days 1, 8, and 15 of a 28-day cycle.\n\nnab-paclitaxel received nab-paclitaxel intravenously at a dose of 100 mg/m2 over 30 minutes on days 1, 8, and 15 of a 28-day cycle.', 'armGroupLabels': ['GnP']}]}, 'contactsLocationsModule': {'locations': [{'zip': '781-8555', 'city': 'Kochi', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Takehiro Okabayashi', 'role': 'CONTACT', 'email': 'tokabaya@gmail.com', 'phone': '+81- 88-837-3000'}], 'facility': 'Takehiro Okabayashi', 'geoPoint': {'lat': 33.55, 'lon': 133.53333}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kochi University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Department of Surgery', 'investigatorFullName': 'Takehiro Okabayashi', 'investigatorAffiliation': 'Kochi University'}}}}