Ignite Creation Date:
2025-12-24 @ 12:56 PM
Ignite Modification Date:
2026-01-06 @ 1:12 AM
Study NCT ID:
NCT01761461
Status:
UNKNOWN
Last Update Posted:
2020-03-25
First Post:
2013-01-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase III Randomized Trial of Adjuvant Chemotherapy With S-1 vs S-1/Oxaliplatin ± Radiotherapy for Completely Resected Gastric Adenocarcinoma : The ARTIST II Trial
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': 'D000077150', 'term': 'Oxaliplatin'}], 'ancestors': [{'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 547}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2013-02-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-03-23', 'studyFirstSubmitDate': '2013-01-03', 'studyFirstSubmitQcDate': '2013-01-03', 'lastUpdatePostDateStruct': {'date': '2020-03-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-01-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary endpoint of the study is disease-free survival (DFS).', 'timeFrame': '3-year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Gastric Cancer']}, 'descriptionModule': {'briefSummary': 'The optimal regimen for adjuvant treatment has not been established in GC yet. We plan to compare TS-1, TS-1/oxaliplatin with or without RT in D2 resected gastric cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Histologically proven gastric or gastroesophageal adenocarcinoma\n2. ≥ D2 lymph node dissection, curative gastrectomy\n3. Stage II, III (AJCC 2010) with any N (any stage with N0 will be excluded)\n4. Age \\> 19\n5. ECOG 0-2\n6. No distant metastasis\n7. Adequate bone marrow functions (ANC ≥ 1,500/ul, blood platelet ≥ 100,000/ul, haemoglobin ≥ 10g/dl, transfusion allowed)\n8. Adequate renal functions(serum creatinine ≤ 1.5mg/dl)\n9. liver functions (serum bilirubin ≤ 1.5mg/dl, AST/ALT ≤ 3 times(normal value)\n10. Written informed consent\n11. Possible oral intake (food, drug)\n\nExclusion Criteria:\n\n* Subjects presenting with any of the following will not be included in the study\n\n 1. Active infection requiring antibiotics\n 2. Pregnant, lactating women\n 3. Concurrent systemic illness not appropriate for chemotherapy\n 4. Resection margin (+) at permanent pathology\n 5. Pathologic stage I or IV (Ia or Ib according to AJCC 2010)\n 6. Inadequate surgery including D0, D1 resection, dissected LNs less than 12\n 7. Paraaortic lymph node (+), pathologically proven\n 8. women of potential childbearing not employing adequate contraception'}, 'identificationModule': {'nctId': 'NCT01761461', 'acronym': 'ARTIST-II', 'briefTitle': 'Phase III Randomized Trial of Adjuvant Chemotherapy With S-1 vs S-1/Oxaliplatin ± Radiotherapy for Completely Resected Gastric Adenocarcinoma : The ARTIST II Trial', 'organization': {'class': 'OTHER', 'fullName': 'Samsung Medical Center'}, 'orgStudyIdInfo': {'id': '2012-06-061'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm A', 'description': 'S-1 40-60mg BID (4weeks - 2weeks off) x 8 cycles', 'interventionNames': ['Drug: TS-1, oxaliplatin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm B', 'description': '{S-1 40-60mg BID (2weeks - 1week off) + Oxaliplatin 130mg/m2 q 3 week} x 8 cycles', 'interventionNames': ['Drug: TS-1, oxaliplatin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm C', 'description': '{S-1 40-60mg BID (2weeks - 1week off) + Oxaliplatin 130mg/m2 q 3 weeks} x 2 cycles → S-1 40mg BID (2weeks - 1week off - 2weeks)+ RT 45 Gy (5weeks) → Rest for 4 weeks → {S-1 40-60mg BID (2weeks - 1week off) + Oxaliplatin 130mg/m2 q 3 weeks} x 4 cycles', 'interventionNames': ['Drug: TS-1, oxaliplatin']}], 'interventions': [{'name': 'TS-1, oxaliplatin', 'type': 'DRUG', 'armGroupLabels': ['Arm A', 'Arm B', 'Arm C']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': 'Samsung Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Samsung Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Won Ki Kang', 'investigatorAffiliation': 'Samsung Medical Center'}}}}