Ignite Creation Date:
2025-12-24 @ 12:31 PM
Ignite Modification Date:
2025-12-26 @ 10:11 AM
Study NCT ID:
NCT00252161
Status:
COMPLETED
Last Update Posted:
2016-09-22
First Post:
2005-11-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Trial of Neoadjuvant TS-1 and Cisplatin for Type 4 and Large Type 3 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': 'D005743', 'term': 'Gastrectomy'}], 'ancestors': [{'id': 'D013505', 'term': 'Digestive System Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 316}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-09-20', 'studyFirstSubmitDate': '2005-11-10', 'studyFirstSubmitQcDate': '2005-11-10', 'lastUpdatePostDateStruct': {'date': '2016-09-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-11-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'overall survival', 'timeFrame': 'during the study conduct'}], 'secondaryOutcomes': [{'measure': 'progression free survival (PFS)', 'timeFrame': 'during the study conduct'}, {'measure': 'response rate', 'timeFrame': 'during the study conduct'}, {'measure': 'proportion of protocol achievement', 'timeFrame': 'during the study conduct'}, {'measure': 'proportion of curative resection', 'timeFrame': 'during the study conduct'}, {'measure': 'adverse events', 'timeFrame': 'during the study conduct'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Neoadjuvant Therapy', 'Stomach Neoplasms', 'Cisplatin', 'S-1(combination)'], 'conditions': ['Gastric Neoplasm']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.jcog.jp/', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to evaluate survival benefit of TS-1 plus cisplatin as a neoadjuvant chemotherapy in gastric cancer patient with resectable type 4 (linitis plastica type) and large type 3 tumor in comparison with surgery alone.', 'detailedDescription': 'A randomized phase III study is going to started in Japan to compare TS-1 plus cisplatin as a neoadjuvant chemotherapy with surgery alone in patient with type 4 and large type 3 gastric cancer.A total of 300 patients will be accrued for this study from 35 institutions within five years. The primary endpoint is overall survival. The secondary endpoints are progression free survival (PFS), response rate, proportion of protocol achievement, proportion of curative resection, and adverse events.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. histologically proven adenocarcinoma of stomach\n2. Borrmann type 4 or large (\\>=8 cm) type 3\n3. no evidence of distant metastasis including liver(M0)\n4. no evidence of para-aortic and/or retropancreatic lymph node metastasis(N0-2)\n5. no peritoneal metastasis and negative peritoneal lavage cytology (PLS) with laparoscopic confirmation\n6. no involvement of the esophagus with \\> 3cm\n7. an age of 20-75 years\n8. an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1\n9. no prior chemotherapy, radiotherapy for any malignancy\n10. no prior surgery for gastric cancer except for endoscopic membrane resection (EMR)\n11. no breeding from primary tumor or gastrointestinal stenosis\n12. sufficient oral intake\n13. adequate organ function\n14. written informed consent\n\nExclusion Criteria:\n\n1. synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ\n2. pregnant or breast-feeding women\n3. severe mental disease\n4. systemic administration of corticosteroids, flucytosine, phenytoin or warfarin\n5. other severe complications such as paralytic ileus, intestinal pneumonitis, pulmonary fibrosis, or ischemic heart disease\n6. myocardial infarction within six disease-free months'}, 'identificationModule': {'nctId': 'NCT00252161', 'briefTitle': 'A Trial of Neoadjuvant TS-1 and Cisplatin for Type 4 and Large Type 3 Gastric Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Japan Clinical Oncology Group'}, 'officialTitle': 'Randomized Phase III Trial of Surgery Plus Neoadjuvant TS-1 and Cisplatin Compared With Surgery Alone for Type 4 and Large Type 3 Gastric Cancer: Japan Clinical Oncology Group Study (JCOG 0501)', 'orgStudyIdInfo': {'id': 'JCOG0501'}, 'secondaryIdInfos': [{'id': 'C000000279', 'type': 'REGISTRY', 'domain': 'UMIN-CTR'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'Procedure/Surgery: Gastrectomy with more than D2 dissection', 'interventionNames': ['Procedure: Gastrectomy with more than D2 dissection']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'Drug: Neoadjuvant chemotherapy(TS-1+CDDP) followed by gastrectomy', 'interventionNames': ['Drug: Neoadjuvant chemotherapy(TS-1+CDDP) followed by gastrectomy']}], 'interventions': [{'name': 'Gastrectomy with more than D2 dissection', 'type': 'PROCEDURE', 'description': 'Gastrectomy with more than D2 dissection', 'armGroupLabels': ['1']}, {'name': 'Neoadjuvant chemotherapy(TS-1+CDDP) followed by gastrectomy', 'type': 'DRUG', 'description': 'Neoadjuvant chemotherapy(TS-1+CDDP) followed by gastrectomy', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '464-8681', 'city': 'Nagoya,Chikusa-ku,Kanokoden,1-1', 'state': 'Aichi-ken', 'country': 'Japan', 'facility': 'Aichi Cancer Center Hospital', 'geoPoint': {'lat': 35.18147, 'lon': 136.90641}}, {'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': '790-0007', 'city': 'Matsuyama,Horinouchi,13', 'state': 'Ehime', 'country': 'Japan', 'facility': 'National Hospital Organization Shikoku Cancer Center'}, {'zip': '500-8323', 'city': 'Gifu,Kashima-cho,7-1', 'state': 'Gifu', 'country': 'Japan', 'facility': 'Gifu Municipal Hospital', 'geoPoint': {'lat': 35.42291, 'lon': 136.76039}}, {'zip': '730-8518', 'city': 'Hiroshima,Naka-ku,Motomachi,7-33', 'state': 'Hiroshima', 'country': 'Japan', 'facility': 'Hiroshima City Hospital'}, {'zip': '664-8540', 'city': 'Itami,Koyaike,1-100', 'state': 'Hyōgo', 'country': 'Japan', 'facility': 'Itami City Hospital', 'geoPoint': {'lat': 34.78427, 'lon': 135.40126}}, {'zip': '020-8505', 'city': 'Morioka,Uchimaru,19-1', 'state': 'Iwate', 'country': 'Japan', 'facility': 'Iwate Medical University'}, {'zip': '890-8520', 'city': 'Kagoshima,Sakuragaoka,8-35-1', 'state': 'Kagoshima-ken', 'country': 'Japan', 'facility': 'Kagoshima University,Faculty of Medicine', 'geoPoint': {'lat': 31.56667, 'lon': 130.55}}, {'zip': '241-0815', 'city': 'Yokohama,Asahi-ku,Nakao,1-1-2', 'state': 'Kanagawa', 'country': 'Japan', 'facility': 'Kanagawa Cancer Center'}, {'zip': '602-8026', 'city': 'Kamigyo-ku,Kamanza-Marutamachi,355-5', 'state': 'Kyoto', 'country': 'Japan', 'facility': 'Kyoto Second Red Cross Hospital', 'geoPoint': {'lat': 35.02954, 'lon': 135.75666}}, {'zip': '981-1293', 'city': 'Natori,Medeshima-Shiode,Nodayama,47-1', 'state': 'Miyagi', 'country': 'Japan', 'facility': 'Miyagi Cancer Center', 'geoPoint': {'lat': 38.16667, 'lon': 140.88333}}, {'zip': '983-8520', 'city': 'Sendai,Miyagino-ku,Miyagino,2-8-8', 'state': 'Miyagi', 'country': 'Japan', 'facility': 'National Hospital Organization, Sendai Medical Center'}, {'zip': '940-8653', 'city': 'Nagaoka,Kawasaki,2041', 'state': 'Niigata', 'country': 'Japan', 'facility': 'Nagaoka Chuo General Hospital'}, {'zip': '951-8566', 'city': 'Niigata,Kawagishi-cho,2-15-3', 'state': 'Niigata', 'country': 'Japan', 'facility': 'Niigata Cancer Center Hospital', 'geoPoint': {'lat': 37.92259, 'lon': 139.04125}}, {'zip': '959-1228', 'city': 'Tsubame,Sawatari,633', 'state': 'Niigata', 'country': 'Japan', 'facility': 'Tsubame Rosai Hospital', 'geoPoint': {'lat': 37.6645, 'lon': 138.92518}}, {'zip': '879-5593', 'city': 'Oita,Hasama-machi,Oogaoka,1-1', 'state': 'Oita Prefecture', 'country': 'Japan', 'facility': 'Oita University Fuculty of Medicine', 'geoPoint': {'lat': 33.23333, 'lon': 131.6}}, {'zip': '540-0006', 'city': 'Osaka,Chuo-ku,Hoenzaka,2-1-14', 'state': 'Osaka', 'country': 'Japan', 'facility': 'Osaka National Hospital'}, {'zip': '537-8511', 'city': 'Osaka,Higashinari-ku,Nakamichi,1-3-3', 'state': 'Osaka', 'country': 'Japan', 'facility': 'Osaka Medical Center for Cancer and Cardiovascular Diseases'}, {'zip': '589-8511', 'city': 'Osaka-Sayama,Ohno-higashi,377-2', 'state': 'Osaka', 'country': 'Japan', 'facility': 'Kinki University School of Medicine', 'geoPoint': {'lat': 34.49524, 'lon': 135.55069}}, {'zip': '590-0064', 'city': 'Sakai,Minamiyasuicho,1-1-1', 'state': 'Osaka', 'country': 'Japan', 'facility': 'Sakai Municipal Hospital', 'geoPoint': {'lat': 34.58216, 'lon': 135.46653}}, {'zip': '569-0801', 'city': 'Takatsuki,Daigakucho,2-7', 'state': 'Osaka', 'country': 'Japan', 'facility': 'Osaka Medical College', 'geoPoint': {'lat': 34.84833, 'lon': 135.61678}}, {'zip': '560-0055', 'city': 'Toyonaka,Shibaharacho,4-14-1', 'state': 'Osaka', 'country': 'Japan', 'facility': 'Toyonaka Municipal Hospital', 'geoPoint': {'lat': 34.78244, 'lon': 135.46932}}, {'zip': '362-0806', 'city': 'Kita-adachi,Ina,Komuro,818', 'state': 'Saitama', 'country': 'Japan', 'facility': 'Saitama Cancer Center'}, {'zip': '359-8513', 'city': 'Tokorozawa,Namiki,3-2', 'state': 'Saitama', 'country': 'Japan', 'facility': 'National Defense Medical College'}, {'zip': '420-8527', 'city': 'Shizuoka,Aoi-ku,Kitaando,4-27-1', 'state': 'Shizuoka', 'country': 'Japan', 'facility': 'Shizuoka General Hospital'}, {'zip': '113-8677', 'city': 'Bunkyo-ku,Honkomagome,3-18-22', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Tokyo Metropolitan Komagome Hospital', 'geoPoint': {'lat': 35.73179, 'lon': 139.74814}}, {'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': '135-8550', 'city': 'Koto-ku,Ariake,3-10-6', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Cancer Institute Hospital', 'geoPoint': {'lat': 35.63561, 'lon': 139.79244}}, {'zip': '162-8655', 'city': 'Shinjuku-ku,Toyama,1-21-1', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'International Medical Center of Japan', 'geoPoint': {'lat': 35.70373, 'lon': 139.71376}}, {'zip': '130-8575', 'city': 'Sumida-ku,Koutoubashi,4-23-15', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Tokyo Metropolitan Bokutoh Hospital'}, {'zip': '930-8550', 'city': 'Toyama,nishinagae,2-2-78', 'state': 'Toyama', 'country': 'Japan', 'facility': 'Toyama Prefectural Central Hospital'}, {'zip': '641-8510', 'city': 'Wakayama,Kimiidera,811-1', 'state': 'Wakayama', 'country': 'Japan', 'facility': 'Wakayama Medical University, School of Medicine'}, {'zip': '990-2292', 'city': 'Yamagata,Aoyagi,1800', 'state': 'Yamagata', 'country': 'Japan', 'facility': 'Yamagata Prefectural Central Hospital', 'geoPoint': {'lat': 38.23333, 'lon': 140.36667}}], 'overallOfficials': [{'name': 'Mitsuru Sasako, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Hyogo Medical 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'}}}}