Ignite Creation Date:
2025-12-24 @ 4:44 PM
Ignite Modification Date:
2026-01-03 @ 7:05 PM
Study NCT ID:
NCT00149266
Status:
TERMINATED
Last Update Posted:
2009-02-03
First Post:
2005-09-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Randomized Controlled Trial to Evaluate Surgical Approaches to Gastric Cancer Invading the Esophagus (JCOG9502)
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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 167}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '1995-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-02', 'completionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-02-02', 'studyFirstSubmitDate': '2005-09-07', 'studyFirstSubmitQcDate': '2005-09-07', 'lastUpdatePostDateStruct': {'date': '2009-02-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'overall survival'}], 'secondaryOutcomes': [{'measure': 'relapse-free survival'}, {'measure': 'operative morbidity and mortality'}, {'measure': 'quality of life'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['stomach neoplasms', 'lymph node resection', 'cardia', 'thoracotomy'], 'conditions': ['Gastric Neoplasm']}, 'referencesModule': {'references': [{'pmid': '16887481', 'type': 'RESULT', 'citation': 'Sasako M, Sano T, Yamamoto S, Sairenji M, Arai K, Kinoshita T, Nashimoto A, Hiratsuka M; Japan Clinical Oncology Group (JCOG9502). Left thoracoabdominal approach versus abdominal-transhiatal approach for gastric cancer of the cardia or subcardia: a randomised controlled trial. Lancet Oncol. 2006 Aug;7(8):644-51. doi: 10.1016/S1470-2045(06)70766-5.'}, {'pmid': '25605628', 'type': 'DERIVED', 'citation': 'Kurokawa Y, Sasako M, Sano T, Yoshikawa T, Iwasaki Y, Nashimoto A, Ito S, Kurita A, Mizusawa J, Nakamura K; Japan Clinical Oncology Group (JCOG9502). Ten-year follow-up results of a randomized clinical trial comparing left thoracoabdominal and abdominal transhiatal approaches to total gastrectomy for adenocarcinoma of the oesophagogastric junction or gastric cardia. Br J Surg. 2015 Mar;102(4):341-8. doi: 10.1002/bjs.9764. Epub 2015 Jan 21.'}, {'pmid': '21104822', 'type': 'DERIVED', 'citation': 'Kurokawa Y, Sasako M, Sano T, Shibata T, Ito S, Nashimoto A, Kurita A, Kinoshita T; Japan Clinical Oncology Group. Functional outcomes after extended surgery for gastric cancer. Br J Surg. 2011 Feb;98(2):239-45. doi: 10.1002/bjs.7297.'}], 'seeAlsoLinks': [{'url': 'http://www.jcog.jp/', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'To compare left thoraco-abdominal approach with abdominal and transhiatal approach to cardia or subcardia cancer', 'detailedDescription': 'For gastric cancers with esophageal invasion (Siewert type II and III), thoraco-abdominal approach has shown better survival results than abdominal approach in retrospective analyses. However, patients having mediastinal nodal metastasis have poor prognosis and the benefit of thoraco-abdominal approach is still controversial. We evaluated the two approaches in a prospective randomized trial.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. histologically proven adenocarcinoma\n2. 75 years old or younger\n3. forced expiratory volume in one second ≥ 50 %\n4. arterial oxygen pressure in room air ≥ 70 mmHg\n5. clinically T2/T3/T4 with ≤3 cm esophageal invasion\n6. written consent\n\nExclusion Criteria:\n\n1. Carcinoma in the remnant stomach\n2. Borrmann type 4 (linitis plastica)\n3. synchronous or metachronous malignancy in other organs except for cervical carcinoma in situ and colorectal focal cancer in adenoma\n4. history of left thoracotomy, or left pleural adhesion\n5. past history of myocardial infarction or positive results of exercise ECG\n6. liver cirrhosis, or chronic liver disease with indocyanine green test ≥15%'}, 'identificationModule': {'nctId': 'NCT00149266', 'briefTitle': 'Randomized Controlled Trial to Evaluate Surgical Approaches to Gastric Cancer Invading the Esophagus (JCOG9502)', 'organization': {'class': 'OTHER', 'fullName': 'Japan Clinical Oncology Group'}, 'officialTitle': 'Randomized Controlled Trial to Evaluate Surgical Approaches to Gastric Cancer Invading the Esophagus (JCOG9502)', 'orgStudyIdInfo': {'id': 'JCOG9502'}, 'secondaryIdInfos': [{'id': 'C000000122'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Surgery: abdominal and transhiatal approach', 'type': 'PROCEDURE'}, {'name': 'Surgery: left thoraco-abdominal approach', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '104-0045', 'city': '5-1-1 Tsukiji, Chuo-ku', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'National Cancer Center Hospital'}], 'overallOfficials': [{'name': 'Mitsuru Sasako, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Gastric Surgery Division, National Cancer Center Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Japan Clinical Oncology Group', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ministry of Health, Labour and Welfare, Japan', 'class': 'OTHER_GOV'}]}}}