Ignite Creation Date:
2025-12-24 @ 9:42 PM
Ignite Modification Date:
2026-04-15 @ 5:55 PM
Study NCT ID:
NCT01471132
Status:
UNKNOWN
Last Update Posted:
2012-12-07
First Post:
2011-11-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sequential HIPEC of Oxaliplatin and Paclitaxel for Gastric Cancer Patients With Peritoneum Metastasis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013274', 'term': 'Stomach 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077150', 'term': 'Oxaliplatin'}, {'id': 'D017239', 'term': 'Paclitaxel'}], 'ancestors': [{'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'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': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2011-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-12', 'completionDateStruct': {'date': '2015-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-12-06', 'studyFirstSubmitDate': '2011-11-01', 'studyFirstSubmitQcDate': '2011-11-10', 'lastUpdatePostDateStruct': {'date': '2012-12-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-11-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Survival', 'timeFrame': 'every 3 month postoperation up to 24 months'}], 'secondaryOutcomes': [{'measure': 'Safety', 'timeFrame': 'every 3 month postoperation up to 24 months', 'description': 'Number of Participants with Adverse Events(III or IV grades according to NCI-CTC)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Gastric Cancer', 'Metastases to Perineum']}, 'descriptionModule': {'briefSummary': 'The recurrence and metastasis of peritoneum is always the lethal consequence for gastric cancer patients, and there is no effective therapy until now. It has been reported by Dr.Fujimoto that intraperitoneal chemotherapy plus hyperthermic therapy, which called hyperthermic intraperitoneal chemotherapy (HIPEC), can eliminate and suppress the free cancer cells and tiny metastasis in abdomen. Refer to the experience of systematic chemotherapy, HIPEC with combination regimen would have a brighter prospect. In this study, the investigators would use Oxaliplatin and paclitaxel sequent as HIPEC regimen. The safety and overall survival would be observed and evaluated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically proved gastric adenocarcinoma.\n* Peritoneum metastasis is observed or suspected by laparoscopy or radiologic examination,or free cancer cells are detected in peritoneal lavage liquid.\n* Potentially resectable gastric cancer.\n* ALT, AST \\< 80U/L; Total Bilirubin \\< 30μmol/L; WBC \\> 4x10\\^9/L; PLT \\> 100x10\\^9/L; Cr \\< 1.5 fold normal value.\n* ECOG 0-2 points.\n* Expected survival time longer than 3 months.\n* Informed consent.\n\nExclusion Criteria:\n\n* Recurrent gastric cancer.\n* Pregnant or lactating women.\n* Allergic to oxaliplatin or paclitaxel.\n* Abnormal liver/kidney function.\n* Serious heart/metabolic disease.'}, 'identificationModule': {'nctId': 'NCT01471132', 'acronym': 'SHOP-G01', 'briefTitle': 'Sequential HIPEC of Oxaliplatin and Paclitaxel for Gastric Cancer Patients With Peritoneum Metastasis', 'organization': {'class': 'OTHER', 'fullName': 'Peking University'}, 'officialTitle': 'Phase 2 Study of Sequential Hyperthermic Intraperitoneal Chemotherapy of Oxaliplatin and Paclitaxel for Gastric Cancer Patients With Peritoneum Metastasis or Positive Free Cancer Cells in Abdomen', 'orgStudyIdInfo': {'id': 'HIPEC-GCOT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HIPEC', 'interventionNames': ['Drug: Oxaliplatin', 'Drug: Paclitaxel']}], 'interventions': [{'name': 'Oxaliplatin', 'type': 'DRUG', 'description': 'Oxaliplatin 345mg/m2,43℃，30mins', 'armGroupLabels': ['HIPEC']}, {'name': 'Paclitaxel', 'type': 'DRUG', 'description': 'Paclitaxel 260mg/m2,43℃，30mins', 'armGroupLabels': ['HIPEC']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100142', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'facility': 'Peking University Cancer Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Xiaojiang Wu', 'role': 'CONTACT', 'email': 'wu.xiaojiang@hotmail.com', 'phone': '8601088196598'}], 'overallOfficials': [{'name': 'Jiafu Ji', 'role': 'STUDY_CHAIR', 'affiliation': 'Peking University Cancer Hospital & Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director', 'investigatorFullName': 'Jiafu Ji', 'investigatorAffiliation': 'Peking University'}}}}