Ignite Creation Date:
2025-12-25 @ 12:04 AM
Ignite Modification Date:
2026-01-22 @ 12:11 PM
Study NCT ID:
NCT02296658
Status:
UNKNOWN
Last Update Posted:
2014-11-20
First Post:
2014-11-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase II Study of Postoperative S-1-Based Chemoradiotherapy in Gastric Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2017-01-19', 'releaseDate': '2016-11-22'}], 'estimatedResultsFirstSubmitDate': '2016-11-22'}}, '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': 'D050397', 'term': 'Radiotherapy, Intensity-Modulated'}, {'id': 'C079198', 'term': 'S 1 (combination)'}], 'ancestors': [{'id': 'D020266', 'term': 'Radiotherapy, Conformal'}, {'id': 'D011881', 'term': 'Radiotherapy, Computer-Assisted'}, {'id': 'D011878', 'term': 'Radiotherapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-11', 'completionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-11-19', 'studyFirstSubmitDate': '2014-11-18', 'studyFirstSubmitQcDate': '2014-11-19', 'lastUpdatePostDateStruct': {'date': '2014-11-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-11-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Comparison of dosimetric differences between radiation techniques', 'timeFrame': '1 year', 'description': 'To compare the dosimetric differences between the volumetric-modulated arc therapy (VMAT), Tomotherapy and intensity-modulated radiotherapy (IMRT) techniques in treatment planning.'}], 'primaryOutcomes': [{'measure': 'Disease free survival', 'timeFrame': '3 years'}, {'measure': 'Locoregional recurrence free survival', 'timeFrame': '3 years'}, {'measure': 'Overall survival', 'timeFrame': '3 years'}, {'measure': 'Distant metastasis free survival', 'timeFrame': '3 years'}], 'secondaryOutcomes': [{'measure': 'Chemoradiotherapy-induced toxicities assessed by CTCAE 4.0', 'timeFrame': 'during treatment and within the first 30 days after completion of chemoradiotherapy'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Stomach Neoplasms', 'Chemoradiotherapy, Adjuvant', 'Radiotherapy, Intensity-Modulated']}, 'descriptionModule': {'briefSummary': 'The aim of this phase II trial was to evaluate the feasibility, efficacy and tolerability of intensity-modulated radiotherapy combined with S-1 based chemotherapy in patients with pathologically positive lymph node after completely resected gastric cancer. Furthermore, the investigators sought to compare the dosimetric differences between the volumetric-modulated arc therapy (VMAT), Tomotherapy and intensity-modulated radiotherapy (IMRT) techniques in treatment planning for gastric cancer as adjuvant radiotherapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pathologically proven positive lymph node gastric adenocarcinoma in patients undergoing R0 resection\n* Any prior chemotherapy is allowed in this protocol\n* No distant metastasis in liver,lung,,bone,central nervous system(CNS),no peritoneal transplantation\n* No prior abdominal or pelvic radiotherapy\n* Karnofsky performance status(KPS)≥ 70, predictive life span no less than 6 months\n* Patients must have normal organ and marrow function as defined below:\n\n * Leukocytes greater than or equal to 3,000 G/L\n * Platelets: greater than or equal to 100,000/mm3\n * Hemoglobin:greater than or equal to 10g/L\n * Total bilirubin: within normal institutional limits\n * AST/ALT: less than or equal to 1.5 times the upper limit\n * Creatinine within normal upper limits\n* Informed consent\n\nExclusion Criteria:\n\n* Patients with other cancer history except cervical carcinoma in situ and non-malignant melanoma skin cancer\n* With any distant metastasis in liver,lung,,bone,CNS,or peritoneal transplantation\n* History of allergic reactions attributed to similar chemical or biologic complex to S-1\n* Uncontrolled illness including, but not limited to, active infection, symptomatic heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\n* History of myocardial infarction within the past 6 months or history of ventricular arrhythmia\n* History of prior radiation to the abdomen\n* Pregnant or lactating females'}, 'identificationModule': {'nctId': 'NCT02296658', 'briefTitle': 'A Phase II Study of Postoperative S-1-Based Chemoradiotherapy in Gastric Cancer', 'organization': {'class': 'UNKNOWN', 'fullName': 'ChineseAMS'}, 'officialTitle': 'A Phase II Trial of Intensity-Modulated Radiotherapy Combined With S-1 Based Chemotherapy in Completely Resected Gastric Cancer', 'orgStudyIdInfo': {'id': 'NCC2013RE-088'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'S-1 based chemoradiotherapy', 'description': 'S-1,80mg/m2/d,peroral BID,in treatment days concurrently with intensity-modulated radiotherapy in a standard manner.', 'interventionNames': ['Radiation: intensity-modulated radiotherapy', 'Drug: S-1']}], 'interventions': [{'name': 'intensity-modulated radiotherapy', 'type': 'RADIATION', 'description': 'A total irradiation dose of 45 Gy was delivered in daily 1.8-Gy fractions (5 days a week over 5 weeks) to all patients.', 'armGroupLabels': ['S-1 based chemoradiotherapy']}, {'name': 'S-1', 'type': 'DRUG', 'description': 'S-1,80mg/m2/d,peroral BID,in treatment days concurrently with intensity-modulated radiotherapy.', 'armGroupLabels': ['S-1 based chemoradiotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100021', 'city': 'Beijing', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xin Wang, MD', 'role': 'CONTACT', 'email': 'beryl_wx2000@163.com', 'phone': '+8613311583220'}], 'facility': 'Department of Radiation Oncology, Cancer Hospital, Chinese Academy of Medical Sciences (CAMS) and Peking Union Medical College (PUMC)', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Jing Jin, MD', 'role': 'CONTACT', 'email': 'jingjin1025@163.com', 'phone': '+8613601365130'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese Academy of Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Cancer Hospital', 'investigatorFullName': 'Wang Xin', 'investigatorAffiliation': 'Chinese Academy of Medical Sciences'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2016-11-22', 'type': 'RELEASE'}, {'date': '2017-01-19', 'type': 'RESET'}], 'unpostedResponsibleParty': ', Cancer Hospital, Chinese Academy of Medical Sciences'}}}}