Ignite Creation Date:
2025-12-24 @ 4:01 PM
Ignite Modification Date:
2025-12-29 @ 2:18 AM
Study NCT ID:
NCT01106066
Status:
TERMINATED
Last Update Posted:
2013-06-14
First Post:
2010-04-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase I/II Study of Neoadjuvant Chemoradiotherapy With S-1/ Oxaliplatin in Patients With Gastric Cancer: Randomized Phase II Study of S-1/RT vs. S-1/Oxaliplatin/RT
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077150', 'term': 'Oxaliplatin'}, {'id': 'C079198', 'term': 'S 1 (combination)'}, {'id': 'D011878', 'term': 'Radiotherapy'}], 'ancestors': [{'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'whyStopped': 'Difficulties in recruiting patients', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2009-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-06', 'completionDateStruct': {'date': '2012-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-06-12', 'studyFirstSubmitDate': '2010-04-15', 'studyFirstSubmitQcDate': '2010-04-15', 'lastUpdatePostDateStruct': {'date': '2013-06-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-04-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'MTD/pathologic CR', 'timeFrame': 'at the time of surgery'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Phase I: To Determine the Maximum Tolerated Dose (MTD)', 'Phase II: To Assess the Pathologic CR Rate and Feasibility Following Neoadjuvant Chemoradiation Therapy With S1/Oxaliplatin']}, 'descriptionModule': {'briefSummary': 'To evaluate the efficacy of preoperative S-1/oxaliplatin/RT in locally advanced gastric cancer'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients older than 18 years\n\n * Patients with localized, histologically confirmed gastric or gastroesophageal adenocarcinoma ③ Localized gastric cancer of clinical stage (T2N(+), T3/T4)\n\n * ECOG performance status of 0 to 1 ⑤ Adequate organ function as evidenced by the following; Absolute neutrophil count \\> 1.5 x 109/L; platelets \\> 100 x 109/L; total bilirubin ≤1.5 UNL; AST and/or ALT \\< 5 UNL; creatinine clearance ≥ 50mL/min ⑥ Written informed consent form\n\nExclusion Criteria:\n\n* T1 (regardless of N stage), T2N0\n\n * M1 ③ Peritoneal seeding ④ Uncontrolled medical condition'}, 'identificationModule': {'nctId': 'NCT01106066', 'briefTitle': 'Phase I/II Study of Neoadjuvant Chemoradiotherapy With S-1/ Oxaliplatin in Patients With Gastric Cancer: Randomized Phase II Study of S-1/RT vs. S-1/Oxaliplatin/RT', 'organization': {'class': 'OTHER', 'fullName': 'Samsung Medical Center'}, 'officialTitle': 'A Phase I/II Study of Neoadjuvant Chemoradiotherapy With S-1/ Oxaliplatin in Patients With Gastric Cancer', 'orgStudyIdInfo': {'id': '2008-06-013'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'S-1/oxaliplatin/RT', 'description': 'Radiotherapy + 4 dose levels of oxaliplatin/S-1', 'interventionNames': ['Drug: Oxaliplatin, S-1, radiotherapy']}], 'interventions': [{'name': 'Oxaliplatin, S-1, radiotherapy', 'type': 'DRUG', 'description': 'Radiotherapy 4000cGy/20 fractions S-1 ( )mg/m2 po bid daily during radiotherapy Oxaliplatin at four dose levels (\\_\\_\\_mg/m2 iv weekly x 4 weeks)', 'armGroupLabels': ['S-1/oxaliplatin/RT']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': 'Samsung Cancer Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Won Ki Kang, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Samsung Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Samsung Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Won Ki Kang', 'investigatorAffiliation': 'Samsung Medical Center'}}}}