Ignite Creation Date:
2025-12-24 @ 9:19 PM
Ignite Modification Date:
2026-02-03 @ 5:48 AM
Study NCT ID:
NCT02269904
Status:
UNKNOWN
Last Update Posted:
2014-10-21
First Post:
2014-10-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fluorouracil Implants Used for Intraperitoneal Chemotherapy During Operation for Treatment of Phase III Gastric Cancer.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-10', 'completionDateStruct': {'date': '2018-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-10-17', 'studyFirstSubmitDate': '2014-10-17', 'studyFirstSubmitQcDate': '2014-10-17', 'lastUpdatePostDateStruct': {'date': '2014-10-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-10-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'DFS (Disease Free Survival)', 'timeFrame': '3 year', 'description': 'During 3 years of monitoring period, any cancer relapse will be recorded'}], 'secondaryOutcomes': [{'measure': 'adverse event', 'timeFrame': '3 years', 'description': 'During 3 years of monitoring period, any AEs will be recorded'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['DSF']}, 'referencesModule': {'references': [{'pmid': '34307140', 'type': 'DERIVED', 'citation': 'Xu Y, Zhang R, Li C, Sun Z, Deng J, Wang X, Ding X, Wang B, Xue Q, Ke B, Zhan H, Liu N, Liu Y, Wang X, Liang H, Xue Y, Xu H. Intraperitoneal Chemotherapy Using Fluorouracil Implants Combined With Radical Resection and Postoperative Adjuvant Chemotherapy for Stage III Gastric Cancer: A Multi-Center, Randomized, Open-Label, Controlled Clinical Study. Front Oncol. 2021 Jul 8;11:670651. doi: 10.3389/fonc.2021.670651. eCollection 2021.'}]}, 'descriptionModule': {'briefSummary': "SinoFuan is a kind of Fluorouracil Implants for intraperitoneal chemotherapy during operation for treatment of gastric cancer. The indication has bee approved by Chinese FDA. The study is a post-marketing study. The subjects will be divided into two groups (Group A and Group B ). The subject in Group A will receive D2 radical gastrectomy(R0),Sinofuan during operation and 6 cycles of Xelox adjuvant chemotherapy.The subject in Group B will receive D2 radical gastrectomy(R0),and 6 cycles of Xelox adjuvant chemotherapy. The subject's benefits from SinoFuan will be analyzed through comparing 3 years DFS of two groups."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. primary gastric cancer, Phase III\n2. D2 radical gastrectomy(R0)\n3. 18 year old or above\n4. KPS≥70%；\n5. suitable hematologic function: ANC≥1.5×109/L, PLC≥80×109/L\n6. suitable liver function: Total bilirubin≤1.5×normal ULN, AST and ALT≤2.5×normal ULN.\n7. suitable renal function: Cr≤1.5×normal ULN,or Ccr≥50 ml/min 8 .for the female subject, pregnancy test must be negative in 27 hours before enrollment .\n\n9\\. the authorized ICF must be signed\n\nExclusion Criteria:\n\n1. non-initial gastric cancer；\n2. having the other uncontrolled diseases.\n3. obvious loss of weight ( more than 10% within 6 weeks )\n4. the female in pregnancy or feeding.\n5. contraindication to study drug\n6. participating in other clinical trial and at the time of treatment period.'}, 'identificationModule': {'nctId': 'NCT02269904', 'briefTitle': 'Fluorouracil Implants Used for Intraperitoneal Chemotherapy During Operation for Treatment of Phase III Gastric Cancer.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Jiangsu Simcere Pharmaceutical Co., Ltd.'}, 'officialTitle': 'Fluorouracil Implants（SinoFuan®）Used for Intraperitoneal Chemotherapy During Operation for Intraperitoneal Chemotherapy During Operation for Treatment of Phase III Gastric Cancer, Randomized, Controlled, Multicentres Open Study.', 'orgStudyIdInfo': {'id': 'Sinofuan01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Fluorouracil Implants and Xelox regimes', 'description': 'Fluorouracil Implants: 800mg, implanted in the abdominal cavity during operation.\n\nXelox regimes: Capecitabine,1000 mg/m2，PO.BID, from D1 to D14; Oxaliplatin, 130 mg/m2，IV, D1 in each cycle. The cycle will repeated every 21 days till 6 cycles finished.', 'interventionNames': ['Drug: Fluorouracil Implants', 'Drug: Xelox regimes']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Xelox regimes', 'description': 'Xelox regimes: Capecitabine,1000 mg/m2，PO.BID, from D1 to D14; Oxaliplatin, 130 mg/m2，IV, D1 in each cycle. The cycle will repeated every 21 days till 6 cycles finished.', 'interventionNames': ['Drug: Xelox regimes']}], 'interventions': [{'name': 'Fluorouracil Implants', 'type': 'DRUG', 'description': 'Fluorouracil Implants: 800mg, implanted in the abdominal cavity during operation.', 'armGroupLabels': ['Fluorouracil Implants and Xelox regimes']}, {'name': 'Xelox regimes', 'type': 'DRUG', 'description': 'Xelox regimes: Capecitabine,1000 mg/m2，PO.BID, from D1 to D14; Oxaliplatin, 130 mg/m2，IV, D1 in each cycle. The cycle will repeated every 21 days till 6 cycles finished.', 'armGroupLabels': ['Fluorouracil Implants and Xelox regimes', 'Xelox regimes']}]}, 'contactsLocationsModule': {'locations': [{'zip': '150000', 'city': 'Harebin', 'state': 'Heilongjiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Chunfeng Li, Doctor', 'role': 'CONTACT', 'email': 'lichunfeng007@163.com', 'phone': '18745787187'}, {'name': 'Yingwei Xue, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Heilongjiang Cancer Hospital'}], 'centralContacts': [{'name': 'Yan Xu, Doctor', 'role': 'CONTACT', 'email': 'xyab@sina.com', 'phone': '13204032770'}, {'name': 'Bo Li, Doctor', 'role': 'CONTACT', 'email': 'ydyyllwyh2010@163.com', 'phone': '13940018765'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jiangsu Simcere Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}