Ignite Creation Date:
2025-12-24 @ 9:09 PM
Ignite Modification Date:
2025-12-28 @ 5:04 PM
Study NCT ID:
NCT01824004
Status:
COMPLETED
Last Update Posted:
2013-04-04
First Post:
2013-03-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Postoperative Chemoradiotherapy With S-1 in 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': 'C079198', 'term': 'S 1 (combination)'}, {'id': 'C103828', 'term': 'titanium silicide'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 46}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-04', 'completionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-04-03', 'studyFirstSubmitDate': '2013-03-28', 'studyFirstSubmitQcDate': '2013-04-03', 'lastUpdatePostDateStruct': {'date': '2013-04-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-04-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Health -related quality of life', 'timeFrame': '6 months after enrollment'}], 'primaryOutcomes': [{'measure': 'Disease free survival', 'timeFrame': '3 years'}], 'secondaryOutcomes': [{'measure': 'Overall Survival', 'timeFrame': '3 years'}, {'measure': 'Number of participants with adverse events as a measure of safety and tolerability', 'timeFrame': '3 year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Gastric cancer', 'Adjuvant', 'Chemoradiotherapy', 'S-1', 'Cisplatin'], 'conditions': ['Gastric Cancer']}, 'descriptionModule': {'briefSummary': 'This study was conducted to evaluate the clinical outcomes and toxicities of adjuvant treatment including S-1/cisplatin chemotherapy followed by S-1 based CRT.', 'detailedDescription': 'Surgery is the only possible curative treatment of gastric cancer. However, the high recurrence rate makes gastric cancer a disease difficult to cure by surgery alone. Despite the benefit of CRT on local recurrence, the distant recurrence is the leading pattern of failure. We hypothesized that gastric cancer outcome could be improved using a more effective chemotherapy regimen. This study was conducted to evaluate the clinical outcomes and toxicity of adjuvant treatment including S-1/cisplatin chemotherapy followed by S-1 based CRT.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\> 18 years\n* Histologically proven gastric adenocarcinoma which is complete resected\n* ECOG performance status of 1 or lower\n* Adequate bone marrow function\n\n * absolute neutrophil count \\[ANC\\] ≥1,500µL, and platelets ≥100,000/µL\n* Adequate kidney function (serum creatinine \\< 1.5 mg/dL)\n* Adequate liver function (serum total bilirubin \\< 2 times the upper normal limit (UNL) serum transaminases levels \\<2 times UNL\n* No prior chemotherapy\n\nExclusion Criteria:\n\n* Other tumor type than adenocarcinoma\n* Evidence of distant metastasis\n* Past or concurrent history of neoplasm except for curatively treated non-melanoma skin cancer or in situ carcinoma of the cervix uteri\n* Uncontrolled infection\n* Unstable cardiac disease despite treatment, myocardial infarction within months prior to study entry\n* History of significant neurologic or psychiatric disorders including dementia or seizures\n* Other serious underlying medical conditions which could impair the ability of the patient to participate in the study\n* Symptoms of gastrointestinal obstruction\n* concomitant drug medication: The following drugs cause drug interaction with S-1.'}, 'identificationModule': {'nctId': 'NCT01824004', 'briefTitle': 'Postoperative Chemoradiotherapy With S-1 in Gastric Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Chonnam National University Hospital'}, 'officialTitle': 'A Phase II Study of Adjuvant S-1/Cisplatin Chemotherapy Followed by S-1-based Chemoradiotherapy in Advanced Gastric Cancer', 'orgStudyIdInfo': {'id': 'CNUHH-MO-03'}, 'secondaryIdInfos': [{'id': 'CNUHH', 'type': 'OTHER_GRANT', 'domain': 'Jeil Pham'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'S-1,chemoradiotherapy, adjuvant treatment', 'description': 'Pts with radically D2 resected adenocarcinoma of the stomach or GEJ in AJCC stage Ib-IV (M0) were eligible for this study. Pts were treated with S-1 (40-60 mg depending on BSA) b.i.d. for 3 wks, and cisplatin (60 mg/m²) iv on day 1, followed by a 2-wk rest period, within a 5-wk cycle. Subsequently, radiotherapy (RT) started which consisted of 25 fractions of 1.8 Gy to a total dose of 45 Gy in 5 wks (5 fractions/wk). On RT days, S-1 (40-60 mg depending on BSA ) b.i.d., 5 days/wk was given. One month after the completion of RT, two 5-wk cycles of S-1/ciplatin chemotherapy were given.', 'interventionNames': ['Drug: S-1']}], 'interventions': [{'name': 'S-1', 'type': 'DRUG', 'otherNames': ['TS-1'], 'armGroupLabels': ['S-1,chemoradiotherapy, adjuvant treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '519-809', 'city': 'Hwasun-Eup', 'state': 'Jeollanam-do', 'country': 'South Korea', 'facility': 'Chonnam National University Hwasun Hospital'}], 'overallOfficials': [{'name': 'Sang-Hee Cho, M.D.Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CNUHH'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chonnam National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Sang-Hee Cho', 'investigatorAffiliation': 'Chonnam National University Hospital'}}}}