Ignite Creation Date:
2025-12-25 @ 12:24 AM
Ignite Modification Date:
2026-02-22 @ 5:09 PM
Study NCT ID:
NCT03618758
Status:
COMPLETED
Last Update Posted:
2023-12-05
First Post:
2018-08-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intraperitoneal Paclitaxel Plus Systemic mFOLFOX6
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013274', 'term': 'Stomach Neoplasms'}, {'id': 'D010534', 'term': 'Peritoneal Neoplasms'}], 'ancestors': [{'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D013272', 'term': 'Stomach Diseases'}, {'id': 'D000008', 'term': 'Abdominal Neoplasms'}, {'id': 'D010532', 'term': 'Peritoneal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017239', 'term': 'Paclitaxel'}, {'id': 'C000708971', 'term': 'genexol-PM'}], 'ancestors': [{'id': 'D043823', 'term': 'Taxoids'}, {'id': 'D043822', 'term': 'Cyclodecanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 35}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-12-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2023-12-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-12-02', 'studyFirstSubmitDate': '2018-08-02', 'studyFirstSubmitQcDate': '2018-08-02', 'lastUpdatePostDateStruct': {'date': '2023-12-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dose determination (Phase 1)', 'timeFrame': '1 Year', 'description': 'Dosage determination of Intraperitoneal Paclitaxel'}, {'measure': 'Overall survival (Phase 2)', 'timeFrame': '1 Year', 'description': '1 year Overall survival with determined dose from Phase 1'}], 'secondaryOutcomes': [{'measure': 'Progression-free survival', 'timeFrame': '1 Year', 'description': '1 year Progression-free survival'}, {'measure': 'Toxicity ratio', 'timeFrame': '3 Years', 'description': 'Toxicity occurrence ratio by CTCAE V.4'}, {'measure': 'Tumor response', 'timeFrame': '3 Years', 'description': 'Tumor response with RECIST criteria V.1.1 and Peritoneal Regression Grading Score(PRGS) system'}, {'measure': 'Conversion surgery ratio', 'timeFrame': '3 Years', 'description': 'Conversion surgery after stable disease or regression'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Gastric cancer', 'Peritoneal carcinomatosis', 'Intraperitoneal chemotherapy', 'Paclitaxel', 'FOLFOX'], 'conditions': ['Gastric Cancer Stage IV', 'Peritoneal Carcinomatosis', 'Intraperitoneal Paclitaxel', 'mFOLFOX6']}, 'descriptionModule': {'briefSummary': "Treatment for stage 4 gastric cancer with peritoneal carcinomatosis has been unchanged for decades. The median survival for stage 4 gastric cancer is 9-14 months with systemic chemotherapy. Intraperitoneal chemotherapy in combination with systemic chemotherapy is under many clinical trials mainly in Japan, and are showing promising results.\n\nThis is Korea's first clinical trial on Intraperitoneal Paclitaxel with Systemic mFOLFOX6 chemotherapy."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '79 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Biopsy proven adenocarcinoma of gastric origin, primary or recurrent\n* Identification of Peritoneal seeding by CT or diagnostic laparoscopy\n* Patients confirmed to receive mFOLFOX6 on multidisciplinary outpatient clinic\n* No previous history of chemotherapy or 4week after the last chemotherapy for gastric cancer\n* Labs adequate for chemotherapy (within 2 weeks of enrollment)\n* Absolute Neutrophil Count: ≧ 1,500/mm³\n* Hemoglobin level: ≧ 8.0g/dL\n* Platelet Count: ≧ 10×104/mm³\n* AST (GOT), ALT (GPT): ≦ 100U/L\n* Total Bilirubin: ≦ 2.0mg/dL\n* Creatinine Clearance (CCl): ≧ 50mL/min\n* ECOG 0 - 2\n* Her-2 negative on endoscopic biopsy\n* Age ≧ 20, \\< 80\n* Signed Informed consent form\n\nExclusion Criteria:\n\n* Patients with other major medical disease or malignant tumors other than gastric cancer\n* Contraindication to 5-FU, Oxaliplatin, Leukovorin or Paclitaxel\n* Pregnant, breast-feeding women or with birth plan\n* Patients refusing treatment'}, 'identificationModule': {'nctId': 'NCT03618758', 'acronym': 'IPLUS', 'briefTitle': 'Intraperitoneal Paclitaxel Plus Systemic mFOLFOX6', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Bundang Hospital'}, 'officialTitle': 'Safety and Efficacy of Intraperitoneal Paclitaxel in Gastric Cancer Patients With Peritoneal Metastasis Receiving Systemic Chemotherapy', 'orgStudyIdInfo': {'id': 'SNUBH_GS_IPEC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Gastric Cancer with Peritoneal Carcinomatosis', 'description': 'Intraperitoneal Chemotherapy (Paclitaxel) + Systemic mFOLFOX6(5-FU, Oxaliplatin, Leucovorin)', 'interventionNames': ['Drug: Paclitaxel', 'Drug: mFOLFOX6 regimen']}], 'interventions': [{'name': 'Paclitaxel', 'type': 'DRUG', 'otherNames': ['(Genexol®)'], 'description': 'Intraperitoneal application of Paclitaxel Phase 1: Dose determination of Paclitaxel (Recommended Dose) Starting from 40mg/m² upto 100mg/m² maximum\n\nPhase 2: Intraperitoneal Paclitaxel with recommended dose', 'armGroupLabels': ['Gastric Cancer with Peritoneal Carcinomatosis']}, {'name': 'mFOLFOX6 regimen', 'type': 'DRUG', 'description': 'Systemic mFOLFOX6: 5-FU(2400mg/m²), Oxaliplatin(100mg/m²), Leucovorin(100mg/m²)', 'armGroupLabels': ['Gastric Cancer with Peritoneal Carcinomatosis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13620', 'city': 'Seongnam-si', 'state': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Seoul National University Bundang Hospital', 'geoPoint': {'lat': 37.43861, 'lon': 127.13778}}], 'overallOfficials': [{'name': 'Hyung-Ho Kim, M.D., PhD.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University Bundang Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Bundang Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Boryung Pharmaceutical Co., Ltd', 'class': 'INDUSTRY'}, {'name': 'B. Braun Korea Co., Ltd.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Hyung-Ho Kim', 'investigatorAffiliation': 'Seoul National University Bundang Hospital'}}}}