Ignite Creation Date:
2025-12-25 @ 2:36 AM
Ignite Modification Date:
2026-01-24 @ 8:18 AM
Study NCT ID:
NCT00216034
Status:
COMPLETED
Last Update Posted:
2016-06-07
First Post:
2005-09-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Randomized Controlled Study of Postoperative Adjuvant Therapy for Gastric Cancer Using TS-1 or TS-1+PSK
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': 'C103828', 'term': 'titanium silicide'}, {'id': 'C010770', 'term': 'polysaccharide-K'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 255}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-06', 'completionDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-06-06', 'studyFirstSubmitDate': '2005-09-18', 'studyFirstSubmitQcDate': '2005-09-20', 'lastUpdatePostDateStruct': {'date': '2016-06-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time of recurrence (calculation of 3-year disease-free survival and overall survival rates)', 'timeFrame': 'Five years after surgery'}], 'secondaryOutcomes': [{'measure': 'Relations of survival rate with compliance, postoperative complication, QOL, adverse events, recurrence status, and expression of immune or tumor markers', 'timeFrame': 'Five years after surgery'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Gastric Cancer', 'TS-1', 'PSK', 'Disease-free survival', 'Overall survival'], 'conditions': ['Gastric Cancer']}, 'referencesModule': {'references': [{'pmid': '7910230', 'type': 'BACKGROUND', 'citation': 'Nakazato H, Koike A, Saji S, Ogawa N, Sakamoto J. Efficacy of immunochemotherapy as adjuvant treatment after curative resection of gastric cancer. Study Group of Immunochemotherapy with PSK for Gastric Cancer. Lancet. 1994 May 7;343(8906):1122-6. doi: 10.1016/s0140-6736(94)90233-x.'}, {'pmid': '16803844', 'type': 'DERIVED', 'citation': 'Ueda Y, Fujimura T, Kinami S, Hirono Y, Yamaguchi A, Naitoh H, Tani T, Kaji M, Yamagishi H, Miwa K; Hokuriku-Kinki Immunochemo-Therapy Study Group-Gastric Cancer (HKIT-GC). A randomized phase III trial of postoperative adjuvant therapy with S-1 alone versus S-1 plus PSK for stage II/IIIA gastric cancer: Hokuriku-Kinki Immunochemo-Therapy Study Group-Gastric Cancer (HKIT-GC). Jpn J Clin Oncol. 2006 Aug;36(8):519-22. doi: 10.1093/jjco/hyl048. Epub 2006 Jun 27.'}]}, 'descriptionModule': {'briefSummary': 'A randomized controlled study is conducted on patients with resected gastric cancer assigned to postoperative adjuvant therapy of TS-1 alone or PSK combined with TS-1, with the objective to examine or validate the outcome, QOL and prognostic factors (host and tumor factors), and explore the factors enhancing the antitumor effect of TS-1.', 'detailedDescription': 'The 5-year survival after gastric cancer surgery remains poor as the cancer advances to stages II, IIIA, IIIB and IV. Tegafur-gimeracil-oteracil potassium (TS-1) is used as the first line treatment for advanced and recurrent gastric cancer. But TS-1 is accompanied by an adverse drug reaction of bone marrow suppression that is not readily seen in conventional oral fluoropyrimidines. Among randomized controlled trials on postoperative adjuvant chemotherapy for gastric cancer, the beneficial results of survival rates using Krestin (PSK) in combination with chemotherapy have been reported. With the objective to enhance the antitumor effect of TS-1 and to improve the QOL of patients, we have planned to validate the clinical significance of combined PSK and TS-1 therapy as postoperative adjuvant therapy for gastric cancer, using in principle the TS-1 regimen of 2-week dosing 1-week off for 6 months followed by 2-week dosing 2-week off for 6 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with microscopic stage II or IIIA resectable gastric cancer\n* Patients who have not received preoperative cancer therapy (radiotherapy, chemotherapy or immunotherapy)\n* Patients with serum immunosuppressive acidic protein (IAP) measured within 2 weeks before surgery\n* Patients with no metachronous or synchronous multiple cancer\n* Patients without severe impairment of renal, hepatic and bone marrow functions\n* Patients who are judged to be capable of tolerating surgery\n* Patients with preoperative performance status 0 to 2\n* Patients with no serious concurrent complications (such as bone marrow suppression, diarrhea and infection)\n* Patients who are judged to be capable of tolerating this treatment, and who have given written informed consent to participate in this study\n\nExclusion Criteria:\n\n* Patients with fresh hemorrhage from the gastrointestinal tract\n* Patients with retention of body fluid necessitating treatment\n* Patients with infection, intestinal palsy or intestinal occlusion\n* Patients who are pregnant or hope to become pregnant during the study period\n* Patients with diabetes treated by continuous use of insulin or showing poor glycemic control\n* Patients with a history of ischemic heart disease\n* Patients with concurrent psychiatric disease or psychotic symptoms, and judged to have difficulties participating in the study\n* Patients receiving continuous administration of steroids\n* Patients who have experienced serious drug allergy in the past\n* Others, patients judged by the investigator or subinvestigator to be inappropriate as subject'}, 'identificationModule': {'nctId': 'NCT00216034', 'briefTitle': 'Randomized Controlled Study of Postoperative Adjuvant Therapy for Gastric Cancer Using TS-1 or TS-1+PSK', 'organization': {'class': 'OTHER', 'fullName': 'Hokuriku-Kinki Immunochemotherapy Study Group'}, 'officialTitle': 'Randomized Multicenter Controlled Phase III Study of Postoperative Adjuvant Therapy for Stage II/IIIA Gastric Cancer Using TS-1 Alone or TS-1+PSK Combined Therapy', 'orgStudyIdInfo': {'id': 'HKIT-GC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'TS-1 Group: The group treated with TS-1 mono-therapy', 'interventionNames': ['Drug: Tegafur-gimeracil-oteracil potassium (TS-1)']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'TS-1+PSK Group: The group treated with combination therapy using TS-1 and PSK', 'interventionNames': ['Drug: Tegafur-gimeracil-oteracil potassium (TS-1)', 'Drug: Krestin (PSK)']}], 'interventions': [{'name': 'Tegafur-gimeracil-oteracil potassium (TS-1)', 'type': 'DRUG', 'otherNames': ['TS-1'], 'description': 'From 4-8 weeks after surgery to 27-31 weeks after surgery, 80 mg/m2, PO from day 1 to day 14 of each 21 day cycle. Number of Cycles: 8 From 28-32 weeks after surgery to 53-57 weeks after surgery, 80 mg/m2, PO from day 1 to day 14 of each 28 day cycle. Number of Cycles: 7', 'armGroupLabels': ['1', '2']}, {'name': 'Krestin (PSK)', 'type': 'DRUG', 'otherNames': ['PSK'], 'description': 'From 4-8 weeks after surgery to 53-57 weeks after surgery, 3 g/day, PO every day', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '910-0833', 'city': 'Fukui-shi', 'state': 'Fukui', 'country': 'Japan', 'facility': 'Fukui Cardio Vascular Center', 'geoPoint': {'lat': 36.06443, 'lon': 136.22257}}, {'zip': '910-8561', 'city': 'Fukui-shi', 'state': 'Fukui', 'country': 'Japan', 'facility': 'Fukui General Hospital', 'geoPoint': {'lat': 36.06443, 'lon': 136.22257}}, {'zip': '918-8503', 'city': 'Fukui-shi', 'state': 'Fukui', 'country': 'Japan', 'facility': 'Fukui Saiseikai Hospital', 'geoPoint': {'lat': 36.06443, 'lon': 136.22257}}, {'zip': '910-1193', 'city': 'Iijima', 'state': 'Fukui', 'country': 'Japan', 'facility': 'University of Fukui Hospital', 'geoPoint': {'lat': 36.09005, 'lon': 136.35994}}, {'zip': '914-0195', 'city': 'Tsuruga', 'state': 'Fukui', 'country': 'Japan', 'facility': 'National Hospital Organization Fukui Hospital', 'geoPoint': {'lat': 35.653, 'lon': 136.06331}}, {'zip': '500-8513', 'city': 'Gifu', 'state': 'Gifu', 'country': 'Japan', 'facility': 'Gifu Municipal Hospital', 'geoPoint': {'lat': 35.42291, 'lon': 136.76039}}, {'zip': '500-8717', 'city': 'Gifu', 'state': 'Gifu', 'country': 'Japan', 'facility': 'Gifu Prefectural General Medical Center', 'geoPoint': {'lat': 35.42291, 'lon': 136.76039}}, {'zip': '501-1194', 'city': 'Gifu', 'state': 'Gifu', 'country': 'Japan', 'facility': 'Gifu University Hospital', 'geoPoint': {'lat': 35.42291, 'lon': 136.76039}}, {'zip': '651-1145', 'city': 'Kobe', 'state': 'Hyōgo', 'country': 'Japan', 'facility': 'Shakaihoken Kobe Central Hospital', 'geoPoint': {'lat': 34.6913, 'lon': 135.183}}, {'zip': '924-8588', 'city': 'Hakusan', 'state': 'Ishikawa-ken', 'country': 'Japan', 'facility': 'Public Central Hospital of Matto Ishikawa', 'geoPoint': {'lat': 36.48204, 'lon': 136.58684}}, {'zip': '920-0934', 'city': 'Kanazawa', 'state': 'Ishikawa-ken', 'country': 'Japan', 'facility': 'Kanazawa University Hospital', 'geoPoint': {'lat': 36.6, 'lon': 136.61667}}, {'zip': '920-8530', 'city': 'Kanazawa', 'state': 'Ishikawa-ken', 'country': 'Japan', 'facility': 'Ishikawa Prefectural Central Hospital', 'geoPoint': {'lat': 36.6, 'lon': 136.61667}}, {'zip': '921-8162', 'city': 'Kanazawa', 'state': 'Ishikawa-ken', 'country': 'Japan', 'facility': 'Kanazawa Redcross Hospital', 'geoPoint': {'lat': 36.6, 'lon': 136.61667}}, {'zip': '920-0293', 'city': 'Mukai-awagasaki', 'state': 'Ishikawa-ken', 'country': 'Japan', 'facility': 'Kanazawa Medical University Hospital', 'geoPoint': {'lat': 36.63246, 'lon': 136.63726}}, {'zip': '620-8505', 'city': 'Fukuchiyama', 'state': 'Kyoto', 'country': 'Japan', 'facility': 'Fukuchiyama City Hospital', 'geoPoint': {'lat': 35.3, 'lon': 135.11667}}, {'zip': '612-8364', 'city': 'Fushimi', 'state': 'Kyoto', 'country': 'Japan', 'facility': 'Kyoto Ohashi General Hospital', 'geoPoint': {'lat': 34.93555, 'lon': 135.76132}}, {'zip': '610-0121', 'city': 'Jōyō', 'state': 'Kyoto', 'country': 'Japan', 'facility': 'Houyu hospital', 'geoPoint': {'lat': 34.84396, 'lon': 135.80561}}, {'zip': '617-0814', 'city': 'Kōtari', 'state': 'Kyoto', 'country': 'Japan', 'facility': 'Saiseikai Kyoto Hospital', 'geoPoint': {'lat': 34.92097, 'lon': 135.70547}}, {'zip': '602-8566', 'city': 'Kyoto', 'state': 'Kyoto', 'country': 'Japan', 'facility': 'University Hospital, Kyoto Prefectural University of Medicine', 'geoPoint': {'lat': 35.02107, 'lon': 135.75385}}, {'zip': '602-8800', 'city': 'Kyoto', 'state': 'Kyoto', 'country': 'Japan', 'facility': 'Nishijin Hospital', 'geoPoint': {'lat': 35.02107, 'lon': 135.75385}}, {'zip': '605-0981', 'city': 'Kyoto', 'state': 'Kyoto', 'country': 'Japan', 'facility': 'Kyoto First Red Cross Hospital', 'geoPoint': {'lat': 35.02107, 'lon': 135.75385}}, {'zip': '625-8502', 'city': 'Maizuru', 'state': 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'Nara', 'country': 'Japan', 'facility': 'Nara City Hospital', 'geoPoint': {'lat': 34.68505, 'lon': 135.80485}}, {'zip': '570-8540', 'city': 'Moriguchi', 'state': 'Osaka', 'country': 'Japan', 'facility': 'Matsushita Memorial Hospital', 'geoPoint': {'lat': 34.73333, 'lon': 135.56667}}, {'zip': '545-0053', 'city': 'Osaka', 'state': 'Osaka', 'country': 'Japan', 'facility': 'Osaka Railway hospital', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}, {'zip': '569-1121', 'city': 'Takatsuki', 'state': 'Osaka', 'country': 'Japan', 'facility': 'Midorigaoka Hospital', 'geoPoint': {'lat': 34.84833, 'lon': 135.61678}}, {'zip': '545-8586', 'city': 'Kembuchi', 'state': 'Osaka Abeno-ku', 'country': 'Japan', 'facility': 'Osaka City University Hospital', 'geoPoint': {'lat': 44.10045, 'lon': 142.357}}, {'zip': '530-0005', 'city': 'Nakanoshima', 'state': 'Osaka Kita-ku', 'country': 'Japan', 'facility': 'Sumitomo Hospital', 'geoPoint': {'lat': 29.86667, 'lon': 129.86667}}, {'zip': '520-2192', 'city': 'Ōtsu', 'state': 'Shiga', 'country': 'Japan', 'facility': 'Shiga University of Medical Science Hospital', 'geoPoint': {'lat': 35.0, 'lon': 135.86667}}, {'zip': '520-3040', 'city': 'Rittō', 'state': 'Shiga', 'country': 'Japan', 'facility': 'Saiseikai Shigaken Hospital', 'geoPoint': {'lat': 35.02745, 'lon': 135.99971}}, {'zip': '693-8501', 'city': 'Izumo', 'state': 'Shimane', 'country': 'Japan', 'facility': 'Shimane University Hospital', 'geoPoint': {'lat': 35.36667, 'lon': 132.76667}}, {'zip': '933-8525', 'city': 'Takaoka', 'state': 'Toyama', 'country': 'Japan', 'facility': 'Saiseikai Takaoka Hospital', 'geoPoint': {'lat': 36.75, 'lon': 137.01667}}, {'zip': '933-8555', 'city': 'Takaoka', 'state': 'Toyama', 'country': 'Japan', 'facility': 'Kouseiren Takaoka Hoapital', 'geoPoint': {'lat': 36.75, 'lon': 137.01667}}, {'zip': '930-8550', 'city': 'Toyama', 'state': 'Toyama', 'country': 'Japan', 'facility': 'Toyama Prefectural Central Hospital', 'geoPoint': {'lat': 36.7, 'lon': 137.21667}}, {'zip': '937-0042', 'city': 'Uozu', 'state': 'Toyama', 'country': 'Japan', 'facility': 'Toyama Rosai Hospital', 'geoPoint': {'lat': 36.8, 'lon': 137.4}}, {'zip': '939-2376', 'city': 'Yatsuomachi-higashikumisaka', 'state': 'Toyama', 'country': 'Japan', 'facility': 'Yatsuo General Hospital', 'geoPoint': {'lat': 36.56667, 'lon': 137.13333}}, {'zip': '644-0011', 'city': 'Gobou', 'state': 'Wakayama', 'country': 'Japan', 'facility': 'Kitade Hospital'}], 'overallOfficials': [{'name': 'Koichi Miwa, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Hokuriku-Kinki Immunochemotherapy Study Group'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hokuriku-Kinki Immunochemotherapy Study Group', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Gastroenterologic Surgery, Kanazawa University Hospital', 'investigatorFullName': 'Takashi Fujimura', 'investigatorAffiliation': 'Hokuriku-Kinki Immunochemotherapy Study Group'}}}}