Ignite Creation Date:
2025-12-25 @ 2:29 AM
Ignite Modification Date:
2025-12-26 @ 1:04 AM
Study NCT ID:
NCT00147134
Status:
COMPLETED
Last Update Posted:
2016-09-22
First Post:
2005-09-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Trial to Evaluate Laparoscopic Versus Open Surgery for Colorectal Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}], 'ancestors': [{'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'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': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1050}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-09-20', 'studyFirstSubmitDate': '2005-09-05', 'studyFirstSubmitQcDate': '2005-09-05', 'lastUpdatePostDateStruct': {'date': '2016-09-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': 'During the study conduct'}], 'secondaryOutcomes': [{'measure': 'Relapse-free survival', 'timeFrame': 'During the study conduct'}, {'measure': 'Short-term clinical outcomes', 'timeFrame': 'time to 1st discharge after operation'}, {'measure': 'Adverse events', 'timeFrame': 'During the study conduct'}, {'measure': 'The proportion of conversion from LAP to OPEN', 'timeFrame': 'operation day'}, {'measure': 'The proportion of completion of LAP', 'timeFrame': 'operation day'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['colorectal cancer', 'laparoscopic surgery', 'randomized controlled trial', 'oncological outcome'], 'conditions': ['Colorectal Cancer']}, 'referencesModule': {'references': [{'pmid': '34755012', 'type': 'DERIVED', 'citation': 'Saito S, Akagi T, Katayama H, Wakabayashi M, Inomata M, Yamamoto S, Ito M, Kinugasa Y, Egi H, Munakata Y, Kokuba Y, Bando H, Yasui M, Ikeda M, Nakajima K, Shida D, Kanemitsu Y, Kitano S; Colorectal Cancer Study Group of Japan Clinical Oncology Group. Identification of patient subgroups with unfavorable long-term outcomes associated with laparoscopic surgery in a randomized controlled trial comparing open and laparoscopic surgery for colon cancer (Japan Clinical Oncology Group Study JCOG0404). Ann Gastroenterol Surg. 2021 Aug 9;5(6):804-812. doi: 10.1002/ags3.12475. eCollection 2021 Nov.'}, {'pmid': '31131360', 'type': 'DERIVED', 'citation': 'Nishizawa Y, Akagi T, Inomata M, Katayama H, Mizusawa J, Yamamoto S, Ito M, Masaki T, Watanabe M, Shimada Y, Kitano S. Risk factors for early postoperative complications after D3 dissection for stage II or III colon cancer: Supplementary analysis of a multicenter randomized controlled trial in Japan (JCOG0404). Ann Gastroenterol Surg. 2019 Apr 4;3(3):310-317. doi: 10.1002/ags3.12246. eCollection 2019 May.'}, {'pmid': '31131359', 'type': 'DERIVED', 'citation': 'Fujii S, Akagi T, Inomata M, Katayama H, Mizusawa J, Ota M, Saito S, Kinugasa Y, Yamaguchi S, Sato T, Kitano S; Japan Clinical Oncology Group. Transitional impact of short- and long-term outcomes of a randomized controlled trial to evaluate laparoscopic versus open surgery for colorectal cancer from Japan Clinical Oncology Group Study JCOG0404. Ann Gastroenterol Surg. 2019 Mar 26;3(3):301-309. doi: 10.1002/ags3.12245. eCollection 2019 May.'}, {'pmid': '28404155', 'type': 'DERIVED', 'citation': 'Kitano S, Inomata M, Mizusawa J, Katayama H, Watanabe M, Yamamoto S, Ito M, Saito S, Fujii S, Konishi F, Saida Y, Hasegawa H, Akagi T, Sugihara K, Yamaguchi T, Masaki T, Fukunaga Y, Murata K, Okajima M, Moriya Y, Shimada Y. Survival outcomes following laparoscopic versus open D3 dissection for stage II or III colon cancer (JCOG0404): a phase 3, randomised controlled trial. Lancet Gastroenterol Hepatol. 2017 Apr;2(4):261-268. doi: 10.1016/S2468-1253(16)30207-2. Epub 2017 Feb 2.'}, {'pmid': '24509190', 'type': 'DERIVED', 'citation': 'Yamamoto S, Inomata M, Katayama H, Mizusawa J, Etoh T, Konishi F, Sugihara K, Watanabe M, Moriya Y, Kitano S; Japan Clinical Oncology Group Colorectal Cancer Study Group. Short-term surgical outcomes from a randomized controlled trial to evaluate laparoscopic and open D3 dissection for stage II/III colon cancer: Japan Clinical Oncology Group Study JCOG 0404. Ann Surg. 2014 Jul;260(1):23-30. doi: 10.1097/SLA.0000000000000499.'}], 'seeAlsoLinks': [{'url': 'http://www.jcog.jp/', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate oncological outcome of patients for T3 and T4 colorectal cancer undergoing laparoscopic versus open surgery.', 'detailedDescription': 'The benefits of laparoscopic surgery (LAP) in comparison to open surgery (OPEN) have been suggested with respect to decreased morbidity, decreased pain, faster recovery, and shorter hospital stay.1-4 However, the long-term survival of LAP for colorectal cancer is still unclear, especially for advanced colorectal cancer requiring extended lymphadenectomy. Thus, the investigators designed a study which investigates whether LAP is suitable for advanced colorectal cancer with respect to survival and post-operative morbidity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Histologically proven colorectal carcinoma\n2. Tumor located in the cecum, ascending colon, sigmoid colon, or rectosigmoid colon\n3. T3 or deeper lesion without involvement of other organs\n4. Without multiple lesion other than carcinoma in situ\n5. Cancer classified as N0-2 and M0, according to the TNM classification system\n6. Tumor size \\< 8 cm\n7. No bowel obstruction\n8. Age 20 \\< and \\> 75 years\n9. Sufficient organ function\n10. No history of gastrointestinal surgery\n11. No history of chemotherapy or radiotherapy\n12. Provided written informed consent\n\nExclusion Criteria:\n\n1. Synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ\n2. Severe pulmonary emphysema, interstitial pneumonitis, or ischemic heart disease\n3. Pregnant or lactating women\n4. Severe mental disease\n5. Continuous systemic steroid therapy'}, 'identificationModule': {'nctId': 'NCT00147134', 'briefTitle': 'A Trial to Evaluate Laparoscopic Versus Open Surgery for Colorectal Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Japan Clinical Oncology Group'}, 'officialTitle': 'Randomized Controlled Trial to Evaluate Laparoscopic Versus Open Surgery for Colorectal Cancer（JCOG 0404,CRC Surg-LAP/OPEN)', 'orgStudyIdInfo': {'id': 'JCOG0404'}, 'secondaryIdInfos': [{'id': 'C000000105'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'Procedure/Surgery: open colectomy', 'interventionNames': ['Procedure: open colectomy']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'Procedure/Surgery: laparoscopic colectomy', 'interventionNames': ['Procedure: laparoscopic colectomy']}], 'interventions': [{'name': 'open colectomy', 'type': 'PROCEDURE', 'description': 'Procedure/Surgery: open colectomy', 'armGroupLabels': ['1']}, {'name': 'laparoscopic colectomy', 'type': 'PROCEDURE', 'description': 'Procedure/Surgery: laparoscopic colectomy', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '470-1192', 'city': 'Toyoake,Kutsukake-cho,Dengakugakubo,1-98', 'state': 'Aichi-ken', 'country': 'Japan', 'facility': 'Fujita Health University', 'geoPoint': {'lat': 35.038, 'lon': 136.99931}}, {'zip': '277-8577', 'city': 'Kashiwa,Kashiwanoha,6-5-1', 'state': 'Chiba', 'country': 'Japan', 'facility': 'National Cancer Center Hospital East'}, {'zip': '285-8741', 'city': 'Sakura,Shimoshidu,564-1', 'state': 'Chiba', 'country': 'Japan', 'facility': 'Toho University Sakura Hospital', 'geoPoint': {'lat': 35.71667, 'lon': 140.23333}}, {'zip': '279-0021', 'city': 'Urayasu,Tomioka,2-1-1', 'state': 'Chiba', 'country': 'Japan', 'facility': 'Jyuntendo Urayasu Hospital'}, {'zip': '790-0007', 'city': 'Matsuyama,Horinouchi,13', 'state': 'Ehime', 'country': 'Japan', 'facility': 'National Hospital Organization Shikoku Cancer Center'}, {'zip': '830-0011', 'city': 'Kurume,Asahi-machi,67', 'state': 'Fukuoka', 'country': 'Japan', 'facility': 'Kurume University School of Medicine'}, {'zip': '734-8551', 'city': 'Hiroshima,Minami-ku,Kasumi,1-2-3', 'state': 'Hiroshima', 'country': 'Japan', 'facility': 'Hiroshima University, School of Medicine', 'geoPoint': {'lat': 34.4, 'lon': 132.45}}, {'zip': '920-8530', 'city': 'Kanazawa,Kuratsuki-Higashi,2-1', 'state': 'Ishikawa-ken', 'country': 'Japan', 'facility': 'Ishikawa Prefectual Central Hospital', 'geoPoint': {'lat': 36.6, 'lon': 136.61667}}, {'zip': '213-8507', 'city': 'Kawasaki,Takatsu-ku,Mizonokuchi,3-8-3', 'state': 'Kanagawa', 'country': 'Japan', 'facility': 'Teikyo University Hospital, Mizonokuchi'}, {'zip': '228-8520', 'city': 'Sagamihara,Asamizodai,2-1-1', 'state': 'Kanagawa', 'country': 'Japan', 'facility': 'Kitasato University East Hospital'}, {'zip': '228-8555', 'city': 'Sagamihara,Kitasato,1-15-1', 'state': 'Kanagawa', 'country': 'Japan', 'facility': 'Kitasato University School of Medichine', 'geoPoint': {'lat': 35.56707, 'lon': 139.24167}}, {'zip': '224-8503', 'city': 'Yokohama,Tsuzuki-ku,Chigasakichuo,35-1', 'state': 'Kanagawa', 'country': 'Japan', 'facility': 'Showa University Northern Yokohama Hospital', 'geoPoint': {'lat': 35.43333, 'lon': 139.65}}, {'zip': '612-8555', 'city': 'Kyoto,Fushimi-ku,Fukakusa,Mukaihata-cho,1-1', 'state': 'Kyoto', 'country': 'Japan', 'facility': 'National Hospital Organization Kyoto Medical Center'}, {'zip': '381-8551', 'city': 'Nagano,Tomitake,1333-1', 'state': 'Nagano', 'country': 'Japan', 'facility': 'Nagano Municipal Hospital', 'geoPoint': {'lat': 36.65, 'lon': 138.18333}}, {'zip': '879-5593', 'city': 'Yufu city,Hasama-machi, 1-1', 'state': 'Oita Prefecture', 'country': 'Japan', 'facility': 'Oita University Faculty of Medicine', 'geoPoint': {'lat': 33.1956, 'lon': 131.37829}}, {'zip': '534-0021', 'city': 'Osaka,Miyakojima-ku,Miyakojimahondori,2-13-22', 'state': 'Osaka', 'country': 'Japan', 'facility': 'Osaka City General Hospital', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}, {'zip': '565-0871', 'city': 'Suita,Yamada-oka,2-2', 'state': 'Osaka', 'country': 'Japan', 'facility': 'Osaka University Graduate School of Medicine', 'geoPoint': {'lat': 34.76143, 'lon': 135.51567}}, {'zip': '569-0801', 'city': 'Takatsuki,Daigakucho,2-7', 'state': 'Osaka', 'country': 'Japan', 'facility': 'Osaka Medical College', 'geoPoint': {'lat': 34.84833, 'lon': 135.61678}}, {'zip': '330-8503', 'city': 'Saitama,Omiya-ku,Amanuma-cho,1-847', 'state': 'Saitama', 'country': 'Japan', 'facility': 'Omiya Medical Center, Jichi Medical School'}, {'zip': '411-8777', 'city': 'Sunto-gun,Nagaizumi-cho,Shimonagakubo,1007', 'state': 'Shizuoka', 'country': 'Japan', 'facility': 'Sizuoka Cancer Center', 'geoPoint': {'lat': 35.15206, 'lon': 138.88634}}, {'zip': '113-8519', 'city': 'Bunkyo-ku,Yushima,1-5-45', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Tokyo Medical and Dental University Hospital', 'geoPoint': {'lat': 35.70603, 'lon': 139.76699}}, {'zip': '104-0045', 'city': 'Chuo-ku,Tsukiji,5-1-1', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'National Cancer Center Hospital', 'geoPoint': {'lat': 35.66487, 'lon': 139.77004}}, {'zip': '153-0044', 'city': 'Meguro-ku,Ohashi,2-17-6', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Toho University Ohashi Hospital', 'geoPoint': {'lat': 35.65268, 'lon': 139.68708}}, {'zip': '105-8470', 'city': 'Minato-ku,Toranomon,2-2-2', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Toranomon Hospital', 'geoPoint': {'lat': 35.66821, 'lon': 139.7442}}, {'zip': '181-8611', 'city': 'Mitaka,Shinkawa,6-20-2', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Kyorin University School of Medicine'}, {'zip': '160-8582', 'city': 'Shinjuku-ku,Shinanomachi,35', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Keio University Hospital', 'geoPoint': {'lat': 35.68194, 'lon': 139.72097}}], 'overallOfficials': [{'name': 'Seigo Kitano, MD, PhD,FACS', 'role': 'STUDY_CHAIR', 'affiliation': 'Oita University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Haruhiko Fukuda', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ministry of Health, Labour and Welfare, Japan', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'JCOG Data Center', 'investigatorFullName': 'Haruhiko Fukuda', 'investigatorAffiliation': 'Japan Clinical Oncology Group'}}}}