Ignite Creation Date:
2025-12-24 @ 11:30 PM
Ignite Modification Date:
2026-02-22 @ 6:46 PM
Study NCT ID:
NCT02636556
Status:
COMPLETED
Last Update Posted:
2020-02-07
First Post:
2015-12-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Chemoradiotherapy for Limited Advanced Unresectable Thymic Epithelial Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013945', 'term': 'Thymoma'}], 'ancestors': [{'id': 'D018193', 'term': 'Neoplasms, Complex and Mixed'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D013953', 'term': 'Thymus Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Intensity modulated radiotherapy with VP-16/Cisplatin'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 56}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2020-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-05', 'studyFirstSubmitDate': '2015-12-15', 'studyFirstSubmitQcDate': '2015-12-18', 'lastUpdatePostDateStruct': {'date': '2020-02-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-12-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Objective response rate', 'timeFrame': '3 months after treatment', 'description': 'Evaluated using RECIST (Response Evaluation Criteria in Solid Tumors) 1.0 criteria'}], 'secondaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': '2 years', 'description': 'from registration to death as a result of any cause.'}, {'measure': 'Progression free survival', 'timeFrame': '2 years', 'description': 'from registration to first documentation of disease progression or death.'}, {'measure': 'Number of Participants with Treatment Related Adverse Events as Assessed by CTCAE v4.0', 'timeFrame': 'up to 2 years', 'description': 'Number of Participants with Treatment Related Adverse Events as Assessed by CTCAE v4.0'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['thymoma', 'thymic carcinoma', 'chemoradiotherapy', 'inoperable'], 'conditions': ['Thymoma and Thymic Carcinoma']}, 'descriptionModule': {'briefSummary': 'This study is designed to evaluate the feasibility and safety of concurrent chemoradiotherapy for limited advanced unresectable thymoma or thymic carcinoma.', 'detailedDescription': 'Complete resection is difficult to achieve without damaging the main organs in advanced thymoma or thymic carcinoma. The previous trials have showed that radiotherapy was significantly associated with prolonged OS and chemotherapy is playing an increasing role in treatment of patients with advanced thymoma or thymic carcinoma. However, whether concurrent chemoradiotherapy is safety in advanced thymoma or thymic carcinoma is still unknown. The purpose of this study is to evaluate the feasibility and safety of concurrent chemoradiotherapy for limited advanced unresectable thymoma or thymic carcinoma.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1.18\\~75 years old; 2.Eastern Cooperative Oncology Group performance status of 0 to 2; 3.Pathologically or cytologically confirmed untreated thymoma or thymic carcinoma; 4.Unresectable, limited adanced disease could be encompassed within a tolerable radiotherapy field; 5.Have adequate bone marrow, hepatic, and renal function; 6.Patients who cannot receive surgery resection; 7.Written informed consent.\n\nExclusion Criteria:\n\n1. Distant metastases could not be encompassed within a tolerable radiotherapy field;\n2. Underwent surgery, radiotherapy or chemotherapy before entering this study ;\n3. Have other malignancy history excluding carcinoma in situ of cervix in the previous five years;\n4. Active clinical pulmonary infection;\n5. Pregnant or nursing.'}, 'identificationModule': {'nctId': 'NCT02636556', 'briefTitle': 'Chemoradiotherapy for Limited Advanced Unresectable Thymic Epithelial Tumors', 'organization': {'class': 'OTHER', 'fullName': 'Fudan University'}, 'officialTitle': 'Phase Ⅱ Study of Concurrent Chemoradiotherapy for Limited Advanced Unresectable Thymic Epithelial Tumors', 'orgStudyIdInfo': {'id': '1508151-5'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'chemoradiation', 'description': 'concurrent chemoradiation.', 'interventionNames': ['Radiation: concurrent chemoradiation']}], 'interventions': [{'name': 'concurrent chemoradiation', 'type': 'RADIATION', 'description': 'The patients receive chemotherapy concurrent with Radiotherapy. The prescription dose is 60Gy in 30 fractions in 6 weeks.The chemotherapy regimen is cisplatin (25mg/m2,iv drip,d1-3) and etoposide (75mg/m2,iv drip,d1-3),q4w\\*4.', 'armGroupLabels': ['chemoradiation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20032', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Kailiang Wu', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'Kailiang Wu, M.D.,Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fudan University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fudan University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'professor', 'investigatorFullName': 'Kailiang Wu', 'investigatorAffiliation': 'Fudan University'}}}}