Ignite Creation Date:
2025-12-25 @ 4:48 AM
Ignite Modification Date:
2025-12-26 @ 3:50 AM
Study NCT ID:
NCT01206218
Status:
UNKNOWN
Last Update Posted:
2010-09-21
First Post:
2010-09-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of Customized Treatment According to BRCA1 Assessment in Patients With Advanced Gastric Cancer
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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 96}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2010-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-09', 'lastUpdateSubmitDate': '2010-09-20', 'studyFirstSubmitDate': '2010-09-20', 'studyFirstSubmitQcDate': '2010-09-20', 'lastUpdatePostDateStruct': {'date': '2010-09-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-09-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression-free Survival', 'timeFrame': '12 months'}], 'secondaryOutcomes': [{'measure': 'Overall Survival', 'timeFrame': '12 months'}, {'measure': 'Response Rate', 'timeFrame': '12 months'}]}, 'conditionsModule': {'keywords': ['Gastric Cancer, BRCA1'], 'conditions': ['Advanced Gastric Cancer']}, 'descriptionModule': {'briefSummary': 'Evaluation of customized treatment according to BRCA1 assessment in patients with advanced gastric cancer'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Provision of informed consent\n* Female or male aged 18 years and over\n* Histologic or cytologic confirmation of advanced gastric cancer\n* Stage III-IV (AJCC 7th)\n* ECOG: 0-2\n* Have tumor sample that can be tested for BRCA1 mRNA expression\n* Negative pregnancy test for women of childbearing potential\n* Neutrophile granulocyte greater than 1.5×10\\^9/L\n* Hemoglobin greater than 10g/dL\n* Platelet greater than 100×10\\^9/L\n* Serum bilirubin not greater than 1.5x upper limit of reference range (ULRR)\n* ALT or AST not greater than 1.5x ULRR\n* Creatinine clearance no less than 60ml/min\n\nExclusion Criteria:\n\n* Have at least another primary malignant tumor\n* Active infection\n* Chemotherapy with experimental drug within 3 weeks before the start of study therapy\n* Women who are pregnant or breast feeding\n* Weight loss greater 10% within 6 weeks before the start of study therapy'}, 'identificationModule': {'nctId': 'NCT01206218', 'acronym': 'BREC-AGC', 'briefTitle': 'Evaluation of Customized Treatment According to BRCA1 Assessment in Patients With Advanced Gastric Cancer', 'organization': {'class': 'OTHER', 'fullName': 'The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School'}, 'officialTitle': 'Evaluation of Customized Treatment According to BRCA1 Assessment in Patients With Advanced Gastric Cancer', 'orgStudyIdInfo': {'id': 'BREC-AGC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group A', 'description': 'FLOT Regimen', 'interventionNames': ['Drug: FLOT Regimen']}, {'type': 'EXPERIMENTAL', 'label': 'Group B', 'description': 'FLO Regimen or FLOT Regimen', 'interventionNames': ['Drug: FLO Regimen or FLOT Regimen']}], 'interventions': [{'name': 'FLOT Regimen', 'type': 'DRUG', 'description': 'FLOT Regimen: 5-fluorouracil, Oxaliplatin, Docetaxel', 'armGroupLabels': ['Group A']}, {'name': 'FLO Regimen or FLOT Regimen', 'type': 'DRUG', 'description': 'FLO Regimen: 5-fluorouracil, Oxaliplatin FLOT Regimen: 5-fluorouracil, Oxaliplatin, Docetaxel', 'armGroupLabels': ['Group B']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Baorui Liu, MD, PHD', 'role': 'CONTACT', 'email': 'baoruiliu@nju.edu.cn', 'phone': '(86)13770621908'}, {'name': 'Jia Wei, MD, PHD', 'role': 'CONTACT', 'email': 'weijia01627@hotmail.com', 'phone': '(86)13951785234'}], 'overallOfficials': [{'name': 'Baorui Liu, MD, PHD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Drum Tower Hospital, Nanjing University Medical School'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Baorui Liu', 'oldOrganization': 'The Comprehensive Cancer Center of Drum Tower Hospital, Nanjing University Medical School'}}}}