Ignite Creation Date:
2025-12-24 @ 7:58 PM
Ignite Modification Date:
2026-01-04 @ 6:07 AM
Study NCT ID:
NCT03238404
Status:
COMPLETED
Last Update Posted:
2017-08-03
First Post:
2017-07-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Neoadjuvant Chemotherapy for Patients With Advanced Gastric Cancer in ERAS Programs for Radical Gastrectomy
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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This study is a single-center, parallel, open-label randomized controlled trial.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 88}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2016-12-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-08-02', 'studyFirstSubmitDate': '2017-07-27', 'studyFirstSubmitQcDate': '2017-08-02', 'lastUpdatePostDateStruct': {'date': '2017-08-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-08-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative length of stay', 'timeFrame': '1 month', 'description': 'Postoperative length of stay'}], 'secondaryOutcomes': [{'measure': 'Postoperative complications', 'timeFrame': '2 months', 'description': 'Postoperative complications'}, {'measure': 'The time to first flatus', 'timeFrame': '1 week', 'description': 'Bowel recovery'}, {'measure': 'Time to semi-liquid diet', 'timeFrame': '2 weeks', 'description': 'Bowel recovery'}, {'measure': 'Total protein', 'timeFrame': '1 week', 'description': 'Nutritional status'}, {'measure': 'Albumin', 'timeFrame': '1 week', 'description': 'Nutritional status'}, {'measure': 'Prealbumin', 'timeFrame': '1 week', 'description': 'Nutritional status'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['gastric cancer', 'neoadjuvant chemotherapy', 'enhanced recovery after surgery', 'gastrectomy'], 'conditions': ['Gastric Cancer']}, 'descriptionModule': {'briefSummary': 'Patients with advanced gastric cancer received neoadjuvant chemotherapy undergo enhanced recovery after surgery (ERAS) programs.', 'detailedDescription': 'In recent years, enhanced recovery after surgery (ERAS) programs were applied in gastrectomy in areas with a high prevalence of gastric cancer, such as China and Japan, confirming that ERAS programs accelerate the postoperative rehabilitation of gastric cancer patients without increasing the occurrence rate of postoperative complications. However, in most studies on ERAS for gastric cancer, patients who received neoadjuvant chemotherapy were excluded. Investigators designed this study aimed to evaluate whether patients who receive neoadjuvant chemotherapy can enrolled into enhanced recovery after surgery programs for locally advanced gastric cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients with locally advanced gastric cancer.\n2. Age older than 18 and younger than 75 years.\n3. American Society of Anesthesiologists (ASA) class: I-III.\n4. Participants can describe the symptom objectively and cooperate actively.\n5. Written informed consent\n\nExclusion Criteria:\n\n1. Patients allergic to oxaliplatin, tegafur gimerac etc.\n2. Patients with ischemic heart disease, cerebrovascular disease and peripheral vascular disease, or cardiac function \\> II (NYHA)\n3. Patients with complications (bleeding, perforation and obstruction) caused by gastric cancer.\n4. Patients with severe liver and renal dysfunction (Child - Pugh ≥ 10; Cr \\< 25 ml/min).\n5. Patients who require simultaneous surgery for other diseases.\n6. Patients who received upper abdominal surgery previously.\n7. Pregnant or breast-feeding women.'}, 'identificationModule': {'nctId': 'NCT03238404', 'briefTitle': 'Neoadjuvant Chemotherapy for Patients With Advanced Gastric Cancer in ERAS Programs for Radical Gastrectomy', 'organization': {'class': 'OTHER', 'fullName': 'Jinling Hospital, China'}, 'officialTitle': 'The Application of Neoadjuvant Chemotherapy for Patients With Advanced Gastric Cancer in Enhanced Recovery After Surgery Programs for Radical Gastrectomy', 'orgStudyIdInfo': {'id': 'BE2015687NAC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'NAC group', 'description': 'Patients will receive neoadjuvant chemotherapy (NAC) before the gastrectomy and ERAS.', 'interventionNames': ['Procedure: NAC group']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Surgery alone group', 'description': 'Patients will not receive NAC before the gastrectomy and ERAS.', 'interventionNames': ['Procedure: Surgery alone group']}], 'interventions': [{'name': 'NAC group', 'type': 'PROCEDURE', 'description': "NAC is the name of a procedure. NAC doesn't mean different interventions are used. Patients in this group need receive this NAC procedure instead of one drug before the gastrectomy and ERAS. The program consists of an intravenous injection of 130 mg/m2 oxaliplatin on day 1, followed by oral administration of 50 mg tegafur gimerac (the name of an anticarcinogen) twice daily on days 1-14, every 3 weeks.", 'armGroupLabels': ['NAC group']}, {'name': 'Surgery alone group', 'type': 'PROCEDURE', 'description': 'Patients will not receive neoadjuvant chemotherapy and they will undergo the gastrectomy and ERAS alone.', 'armGroupLabels': ['Surgery alone group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '210002', 'city': 'Nanjing', 'state': 'Jiangsu', 'country': 'China', 'facility': 'Jinling Hospital, Medical School of Nanjing University', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}], 'overallOfficials': [{'name': 'Zhi-Wei JIANG, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Jinling Hospital, Medical School of Nanjing University'}, {'name': 'Jian ZHAO, Ph.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Jinling Hospital, Medical School of Nanjing University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'The results and IPD will be considered to share in published articles.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'JIANG Zhi-Wei', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Vice director of Research Institute of General Surgery', 'investigatorFullName': 'JIANG Zhi-Wei', 'investigatorAffiliation': 'Jinling Hospital, China'}}}}