Ignite Creation Date:
2025-12-24 @ 9:14 PM
Ignite Modification Date:
2026-01-04 @ 7:54 AM
Study NCT ID:
NCT01088204
Status:
UNKNOWN
Last Update Posted:
2015-10-07
First Post:
2010-03-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Feasibility Study of Laparoscopy-assisted D2 Distal Gastrectomy to Treat 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'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 204}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2010-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-10-05', 'studyFirstSubmitDate': '2010-03-15', 'studyFirstSubmitQcDate': '2010-03-16', 'lastUpdatePostDateStruct': {'date': '2015-10-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-03-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'noncompliance rate', 'timeFrame': 'postoperative 1 week', 'description': 'A Case will be designated as "noncompliant" when there are more than one missing lymph node station according to the guidelines of "The Japanese Research Society for Gastric Cancer" (JRSGC) lymph node grouping'}], 'secondaryOutcomes': [{'measure': 'Postoperative surgical complications', 'timeFrame': 'postoperative 1 day, 1 week, 1 months, 3 months, 6 months, 12 months', 'description': 'Major and minor, and short term and long term complications related with surgery will be monitored and recorded according to classification of Accordion Severity Classification of Postoperative Complications; Expanded Classification.'}, {'measure': 'operating time', 'timeFrame': 'operation day', 'description': 'From skin incision to wound closure'}, {'measure': 'time to first flatus', 'timeFrame': 'postoperative 1 week', 'description': 'the day when a patient relieve gastrointestinal gas'}, {'measure': 'number of retrieved lymph nodes', 'timeFrame': 'postoperative 1 week'}, {'measure': 'number of retrieved lymph nodes at each stations', 'timeFrame': 'postoperative 1 week'}, {'measure': 'proximal resection margin', 'timeFrame': 'postoperative 1 week'}, {'measure': 'distal resection margin,', 'timeFrame': 'postoperative 1 week'}, {'measure': 'unanimity rate of 3 randomly assigned laparoscopic gastric cancer surgeons', 'timeFrame': 'postoperative 3 months', 'description': 'Three randomly assigned laparoscopic gastric cancer surgeons would evaluate the uneditted video and photoes and validate the lymph node dissection according to each stations.When the three surgeons agree that D2 lymph node dissection was performed, it is considered as unanimity.'}, {'measure': '3-year disease free survival', 'timeFrame': 'postoperative 3 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Gastric Cancer']}, 'referencesModule': {'references': [{'pmid': '28187041', 'type': 'DERIVED', 'citation': 'Park YK, Yoon HM, Kim YW, Park JY, Ryu KW, Lee YJ, Jeong O, Yoon KY, Lee JH, Lee SE, Yu W, Jeong SH, Kim T, Kim S, Nam BH; COACT group. Laparoscopy-assisted versus Open D2 Distal Gastrectomy for Advanced Gastric Cancer: Results From a Randomized Phase II Multicenter Clinical Trial (COACT 1001). Ann Surg. 2018 Apr;267(4):638-645. doi: 10.1097/SLA.0000000000002168.'}, {'pmid': '24156036', 'type': 'DERIVED', 'citation': 'Nam BH, Kim YW, Reim D, Eom BW, Yu WS, Park YK, Ryu KW, Lee YJ, Yoon HM, Lee JH, Jeong O, Jeong SH, Lee SE, Lee SH, Yoon KY, Seo KW, Chung HY, Kwon OK, Kim TB, Lee WK, Park SH, Sul JY, Yang DH, Lee JS. Laparoscopy Assisted versus Open Distal Gastrectomy with D2 Lymph Node Dissection for Advanced Gastric Cancer: Design and Rationale of a Phase II Randomized Controlled Multicenter Trial (COACT 1001). J Gastric Cancer. 2013 Sep;13(3):164-71. doi: 10.5230/jgc.2013.13.3.164. Epub 2013 Sep 30.'}], 'seeAlsoLinks': [{'url': 'http://ncc.re.kr', 'label': 'National Cancer Center web site'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the oncological feasibility of laparoscopy-assisted distal gastrectomy with D2 lymph node dissection for advanced gastric cancer.', 'detailedDescription': 'To test oncological feasibility, compliance of nodal dissection was selected as a primary end point. When there are more than two missing nodal station(no lymph nodes in dissected area), it is defined as a non-compliant nodal dissection. Other secondary outcomes will be supplementary to evaluate feasibility of D2 dissection.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* histologically proven primary gastric adenocarcinoma\n* T2 or T3 or T4a, N0 or N1 or N2 or N3a (AJCC 7th), which is assessed by computed tomography (CT) scan - mid 1/3 or low 1/3 location\n* No evidence of other distant metastasis\n* not stump carcinoma,(vi) aged 20-80 year old\n* performance status (PS) of 0 or 1 on Eastern Cooperative Oncology Group (ECOG) scale\n* no prior treatment of chemotherapy or radiation therapy against any other malignancies, and no prior treatment for gastric cancer including endoscopic mucosal resection\n* adequate organ functions defined as indicated below:\n\n * WBC 3000/mm3, WBC 12 000/mm3\n * Hb 8.0 g/dl without any transfusion 2 weeks before enrollment\n * Plt 100 000/mm3\n * AST 100 IU/l\n * ALT 100 IU/l\n * T.Bil 2.0 mg/dl\n * written informed consent\n\nExclusion Criteria:\n\n* active double cancer (synchronous double cancer and metachronous double cancer within five disease-free years), excluding carcinoma in situ (lesions equal to intraepithelial or intramucosal cancer)\n* pregnant or breast-feeding women\n* severe mental disorder\n* systemic administration of corticosteroids\n* unstable angina or myocardial infarction within 6 months of the trial\n* unstable hypertension\n* severe respiratory disease requiring continuous oxygen therapy\n* previous upper abdominal surgery except laparoscopic cholecystectomy'}, 'identificationModule': {'nctId': 'NCT01088204', 'acronym': 'COACT_1001', 'briefTitle': 'Feasibility Study of Laparoscopy-assisted D2 Distal Gastrectomy to Treat Advanced Gastric Cancer', 'organization': {'class': 'OTHER_GOV', 'fullName': 'National Cancer Center, Korea'}, 'officialTitle': 'A Multicenter Randomized Phase II Clinical Trial of Laparoscopy Assisted Versus Open Distal Gastrectomy With D2 Lymph Node Dissection for Advanced Gastric Cancer', 'orgStudyIdInfo': {'id': 'NCCCTS-09-448'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'open distal gastrectomy', 'description': 'open distal gastrectomy with D2 lymph node dissection for patients with advanced gastric cancer', 'interventionNames': ['Procedure: open distal gastrectomy']}, {'type': 'EXPERIMENTAL', 'label': 'laparoscopy assisted distal gastrectomy', 'description': 'laparoscopy assisted distal gastrectomy with D2 lymph node dissection for patients with advanced gastric cancer', 'interventionNames': ['Procedure: laparoscopy assisted distal gastrectomy']}], 'interventions': [{'name': 'laparoscopy assisted distal gastrectomy', 'type': 'PROCEDURE', 'otherNames': ['LADG'], 'description': 'laparoscopy assisted distal gastrectomy with D2 lymph node dissection for patients with advanced gastric cancer', 'armGroupLabels': ['laparoscopy assisted distal gastrectomy']}, {'name': 'open distal gastrectomy', 'type': 'PROCEDURE', 'otherNames': ['ODG'], 'description': 'open distal gastrectomy with D2 lymph node dissection for patients with advanced gastric cancer', 'armGroupLabels': ['open distal gastrectomy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '519-763', 'city': 'Hwasun', 'state': 'Chollanam Do', 'country': 'South Korea', 'facility': 'Chonnam National University Hwasun Hospital', 'geoPoint': {'lat': 35.06125, 'lon': 126.98746}}, {'zip': '411-764', 'city': 'Goyang-si', 'state': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'National Cancer Center', 'geoPoint': {'lat': 37.65639, 'lon': 126.835}}, {'zip': '660-702', 'city': 'Jinju', 'state': 'Gyeongsangnam-do', 'country': 'South Korea', 'facility': 'Gyengsang National University Hospital', 'geoPoint': {'lat': 35.19278, 'lon': 128.08472}}, {'zip': '700-721', 'city': 'Daegu', 'country': 'South Korea', 'facility': 'Kyungpook national university hospital', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}, {'zip': '704-802', 'city': 'Daegu', 'country': 'South Korea', 'facility': 'Dae Gu Veterans Hospital', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}, {'zip': '302-718', 'city': 'Daejeon', 'country': 'South Korea', 'facility': 'Konyang University Hospital', 'geoPoint': {'lat': 36.34913, 'lon': 127.38493}}, {'zip': '602-702', 'city': 'Pusan', 'country': 'South Korea', 'facility': 'Kosin University Gospel Hospital', 'geoPoint': {'lat': 36.3809, 'lon': 128.3681}}], 'overallOfficials': [{'name': 'Young-Woo Kim, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Cancer Center, Korea'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Cancer Center, Korea', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Department of Gastric Cancer Surgery', 'investigatorFullName': 'Young-Woo Kim', 'investigatorAffiliation': 'National Cancer Center, Korea'}}}}