Ignite Creation Date:
2025-12-24 @ 11:03 PM
Ignite Modification Date:
2026-03-01 @ 2:44 AM
Study NCT ID:
NCT03322969
Status:
UNKNOWN
Last Update Posted:
2021-02-26
First Post:
2017-10-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Receiving Modified Chemotherapy Followed With Radical Resection After Neoadjuvant Chemotherapy
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': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-08-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2023-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-02-23', 'studyFirstSubmitDate': '2017-10-24', 'studyFirstSubmitQcDate': '2017-10-24', 'lastUpdatePostDateStruct': {'date': '2021-02-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-10-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'disease free survival', 'timeFrame': '3 year', 'description': 'DFS between two arms'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Locally Advanced Gastric Cancer']}, 'descriptionModule': {'briefSummary': 'For patients undergoing postoperative therapy for locally advanced gastric cancer after neoadjuvant chemotherapy, we assessed the utility of graded histologic regression of \\<50% as the criterion of treatment change. Sixty patients will be enrolled to randomize into two groups：receiving modified chemotherapy and receiving the original chemotherapy.', 'detailedDescription': 'For patients undergoing postoperative therapy for locally advanced gastric cancer after neoadjuvant chemotherapy, we assessed the utility of graded histologic regression of \\<50% as the criterion of treatment change. Sixty patients will be enrolled to randomize into two groups：receiving modified chemotherapy and receiving the original chemotherapy. Overall survival and disease-free survival will be observed between two groups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* TNM stage of T2-T4 or positive regional lymph nodes, according to the American Joint Committee on Cancer (AJCC) 7.0 staging system, verified by enhanced abdominal computed tomography (CT) and/or endoscopic ultrasound (EUS), positron emission tomography (PET)/CT scan), with no evidence of distant metastases;\n* ECOG performance status score ≤2 without serious heart, lung, liver, kidney, or hematological dysfunctions;\n* age ≥18 years old;\n* no previous chemotherapy, radiotherapy, or surgical treatment for gastric cancer;\n* gastrectomy was performed after preoperative chemotherapy if imaging studies did not confirm disease progression (according to the Response Evaluation Criteria in Solid Tumors (RECIST)) ;\n* signed the informed consent form.\n\nExclusion Criteria:\n\n* All do not reach the inclusion criteria'}, 'identificationModule': {'nctId': 'NCT03322969', 'briefTitle': 'Receiving Modified Chemotherapy Followed With Radical Resection After Neoadjuvant Chemotherapy', 'organization': {'class': 'OTHER', 'fullName': 'Peking Union Medical College Hospital'}, 'officialTitle': 'Receiving Modified Chemotherapy Followed With Radical Resection After Neoadjuvant Chemotherapy Versus Receiving the Original Chemotherapy in Locally Advanced Gastric Cancer: a Randomized Controlled Study', 'orgStudyIdInfo': {'id': 'NAC-GC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'receiving modified chemotherapy', 'description': 'Paclitaxel/DDP', 'interventionNames': ['Drug: Paclitaxel/DDP']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'receiving the original chemotherapy', 'description': 'XELOX/SOX', 'interventionNames': ['Drug: XELOX/SOX']}], 'interventions': [{'name': 'Paclitaxel/DDP', 'type': 'DRUG', 'otherNames': ['Group A'], 'description': 'receiving the modified chemotherapy', 'armGroupLabels': ['receiving modified chemotherapy']}, {'name': 'XELOX/SOX', 'type': 'DRUG', 'otherNames': ['Group B'], 'description': 'receiving the original chemotherapy', 'armGroupLabels': ['receiving the original chemotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100032', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiang Wang, Doctor', 'role': 'CONTACT', 'email': 'wangxiang5123@126.com', 'phone': '011-86-10-69151279'}], 'facility': 'Department of Medical Oncology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Xiang Wang, Doctor', 'role': 'CONTACT', 'email': 'wangxiang5123@126.com', 'phone': '011-86-10-69151279'}, {'name': 'Lin Zhao, Doctor', 'role': 'CONTACT', 'email': 'wz20010727@aliyun.com', 'phone': '011-86-10-69151279'}], 'overallOfficials': [{'name': 'Lin Zhao, Doctor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Department of Medical Oncology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking Union Medical College Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}