Ignite Creation Date:
2025-12-24 @ 3:06 PM
Ignite Modification Date:
2025-12-24 @ 3:06 PM
Study NCT ID:
NCT03814759
Status:
COMPLETED
Last Update Posted:
2024-12-27
First Post:
2019-01-23
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Preoperative Chemoradiotherapy for Locally Advanced Resectable Gastric Adenocarcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C103828', 'term': 'titanium silicide'}, {'id': 'D002945', 'term': 'Cisplatin'}, {'id': 'D011827', 'term': 'Radiation'}], 'ancestors': [{'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D017671', 'term': 'Platinum Compounds'}, {'id': 'D055585', 'term': 'Physical Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 102}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-12-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2022-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-22', 'studyFirstSubmitDate': '2019-01-23', 'studyFirstSubmitQcDate': '2019-01-23', 'lastUpdatePostDateStruct': {'date': '2024-12-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-01-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'pathological response rate', 'timeFrame': '10 week', 'description': 'to evaluate pathological response rate in locally advanced resectable gastric cancer'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Gastric Adenocarcinoma']}, 'descriptionModule': {'briefSummary': 'Gastric cancer is a high incidence in Asia, and one of the leading cause of death in Korea. A cure rate is improving due to early diagnosis. However, the 5-year survival rate of gastric cancer excluding early gastric cancer is about 40 \\~ 67%. Therefore, several methods for lowering the recurrence rate have been attempted and concurrent chemoradiotherapy can be considered as a method to lower the recurrence rate of gastric cancer. The purpose of this study is to evaluate the pathologic response rate and safety of patients who underwent surgery after chemoradiotherapy.', 'detailedDescription': 'Gastric cancer is a high incidence in Asia, and one of the leading cause of death in Korea. A cure rate is improving due to early diagnosis. However, the 5-year survival rate of gastric cancer excluding early gastric cancer is about 40 \\~ 67%. Therefore, several methods for lowering the recurrence rate have been attempted and concurrent chemoradiotherapy can be considered as a method to lower the recurrence rate of gastric cancer. The purpose of this study is to evaluate the pathologic response rate and safety of patients who underwent surgery after chemoradiotherapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age ≥ 20 years old\n2. Histologically confirmed gastric adenocarcinoma\n3. clinical stage : resectable gastric cancer\n\n * advanced confirmed (EGD)\n * extramural infiltration\\> 1 mm (CT)\n * positive serosa invasion (EUS)\n4. Eastern Cooperative Oncology Group performance status 0 or 1\n5. no prior chemotherapy and radiotherapy\n6. measurable lesion or evaluable lesion according to Response Evaluation Criteria in Solid Tumors version 1.1 criteria\n7. Patients with adequate organ function\n8. Signed informed consent\n\nExclusion Criteria:\n\n1. Metastasis esophageal invasion \\> 3cm\n2. inoperable peritoneal seeding disease determined by exploratory laparotomy\n3. T4b invading the surrounding organs\n4. lymph node metastasis outside the celiac trunk Lymph node and splenic lymph node\n5. uncontrolled viral infections (HIV, HBV, HCV)\n6. Pregnant or lactating women, women of childbearing potential not employing adequate contraception\n7. severe hypersensitivity reactions to S-1, cisplatin\n8. Subjects with uncontrolled clinically significant cardiovascular medical history, uncontrolled infection or complication\n9. Other co-existing malignancies or malignancies diagnosed within the last 5 years except for curatively treated non-melanoma skin cancer or in situ carcinoma of the cervix'}, 'identificationModule': {'nctId': 'NCT03814759', 'briefTitle': 'Preoperative Chemoradiotherapy for Locally Advanced Resectable Gastric Adenocarcinoma', 'organization': {'class': 'OTHER', 'fullName': 'Yonsei University'}, 'officialTitle': 'Preoperative S-1 Plus Cisplatin-based Chemoradiotherapy for Locally Advanced Resectable Gastric Adenocarcinoma : Randomized, Phase II Trial', 'orgStudyIdInfo': {'id': '4-2015-0603'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SP+CCRT', 'description': 'S-1 20mg/m2, bid (D1\\~14, D22\\~35) Cisplatin 30mg/m2/day (W1, 2, 4, 5) radiation 45Gy per 5 weeks', 'interventionNames': ['Drug: TS-1 + cisplatin', 'Radiation: radiation']}], 'interventions': [{'name': 'TS-1 + cisplatin', 'type': 'DRUG', 'description': 'S-1 20mg/m2, bid (D1\\~14, D22\\~35) Cisplatin 30mg/m2/day (W1, 2, 4, 5)', 'armGroupLabels': ['SP+CCRT']}, {'name': 'radiation', 'type': 'RADIATION', 'description': 'radiation 45Gy per 5 weeks', 'armGroupLabels': ['SP+CCRT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '03722', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Severance Hospital, Yonsei University Health System', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yonsei University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'professor', 'investigatorFullName': 'Hyo Song Kim', 'investigatorAffiliation': 'Yonsei University'}}}}