Ignite Creation Date:
2025-12-25 @ 12:44 AM
Ignite Modification Date:
2025-12-25 @ 10:56 PM
Study NCT ID:
NCT06313567
Status:
RECRUITING
Last Update Posted:
2024-07-08
First Post:
2024-03-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Metronomic Capecitabine in Stage III 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019370', 'term': 'Observation'}], 'ancestors': [{'id': 'D008722', 'term': 'Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 722}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-03-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2029-03-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-04', 'studyFirstSubmitDate': '2024-03-10', 'studyFirstSubmitQcDate': '2024-03-10', 'lastUpdatePostDateStruct': {'date': '2024-07-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-03-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Disease-free survival', 'timeFrame': '3-year', 'description': 'DFS'}], 'secondaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': '3-year', 'description': 'OS'}, {'measure': 'Side effects', 'timeFrame': '1-year', 'description': 'Complications such as Nausea, vomiting, myelosuppression and Liver or kidney function disorder'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Gastric Cancer', 'Metronomic capecitabine'], 'conditions': ['Gastric Cancer']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to find out whether treatment with metronomic capecitabine will improve the survival of gastric cancer patients with stage III who had received standard treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Lower age limit of research subjects 18 years old and upper age limit of 80 years old.\n2. Be proven to be primary adenocarcinoma of gastric cancer and staged III by pathological evidences\n3. R0 gastrectomy with D2 lymphadenectomy\n4. ECOG (ECOG score standard) performance status of 0 or 1 and expected to survive more than 6 months\n5. No contraindications, including normal peripheral blood routine, liver and kidney function and electrocardiogram （WBC≥3.5 x 109 /L, NEU≥1.2 x 109 /L,PLT≥90 x 109 /L and HGB≥80g/L).\n\nExclusion Criteria:\n\n1. History of chemotherapy, radiotherapy, immunotherapy or target therapy\n2. Multiple primary tumors\n3. Suffering from other serious diseases, including cardiovascular, respiratory, kidney, or liver disease, complicated by poorly controlled hypertension, diabetes, mental disorders or diseases\n4. Unavailable for R0 resection and D2 lymph node dissection.\n5. Patients with stage IV gastric cancer'}, 'identificationModule': {'nctId': 'NCT06313567', 'briefTitle': 'Metronomic Capecitabine in Stage III Gastric Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Fudan University'}, 'officialTitle': 'Metronomic Capecitabine as Adjuvant Therapy in Stage III Gastric Cancer: a Multicentre, Open-label, Parallel-group, Randomised, Controlled, Phase 3 Trial', 'orgStudyIdInfo': {'id': 'Meca-GC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Metronomic capecitabine', 'description': 'Low-dose capecitabine maintenance (500 mg/m2 body surface area twice daily for 1 year) after completion of standard adjuvant chemotherapy,', 'interventionNames': ['Drug: Metronomic capecitabine group']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard therapy group', 'description': 'Observation after completion of standard adjuvant chemotherapy,', 'interventionNames': ['Other: Observation']}], 'interventions': [{'name': 'Metronomic capecitabine group', 'type': 'DRUG', 'description': '500 mg/m2 body surface area twice daily for 1 year; metronomic capecitabine group', 'armGroupLabels': ['Metronomic capecitabine']}, {'name': 'Observation', 'type': 'OTHER', 'description': 'observation', 'armGroupLabels': ['Standard therapy group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200000', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Dazhi Xu, MD,PHD', 'role': 'CONTACT', 'email': 'xudzh@shca.org.cn', 'phone': '021-64175590'}], 'facility': 'Fudan University Shanghai Cancer Center', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Jing Guo, MD', 'role': 'CONTACT', 'email': 'gjsysu@126.com', 'phone': '021-64175590'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fudan University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Dazhi Xu', 'investigatorAffiliation': 'Fudan University'}}}}