Ignite Creation Date:
2025-12-25 @ 3:24 AM
Ignite Modification Date:
2026-02-21 @ 5:46 PM
Study NCT ID:
NCT02014805
Status:
UNKNOWN
Last Update Posted:
2020-07-16
First Post:
2013-12-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Postoperative Conformal Radiotherapy for Stage II-III B Type Thymoma
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011878', 'term': 'Radiotherapy'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 210}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2022-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-07-14', 'studyFirstSubmitDate': '2013-12-07', 'studyFirstSubmitQcDate': '2013-12-12', 'lastUpdatePostDateStruct': {'date': '2020-07-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-12-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'rate of acute and late radiation toxicity', 'timeFrame': 'within 3 year after the end of all enrollment', 'description': 'toxicity: including the acute radition-induced lung toxicity and the late lung toxicity at 1, 3, 6, 9, 12, 18, 24, 30 and 36 month after radiation or observation'}, {'measure': 'quality of life score', 'timeFrame': 'within 3 years after all enrollment', 'description': 'quality of life: FACT-Lung and EORTC QOL C30 before and after radiation, and at 1, 3, 6, 9, 12, 18, 24, 30, 36 months after radiation or observation'}], 'primaryOutcomes': [{'measure': '3 year local control rate', 'timeFrame': '3 year after the end of all enrollment', 'description': 'local control: tumor recurrence in the tumor bed 3 year local control rate: number of patients with tumor recurrence in the tumor bed at 3 years'}], 'secondaryOutcomes': [{'measure': '3 year failure-free and overall survival', 'timeFrame': '3 year after the end of all enrollment', 'description': 'failure-free survivail: the interval from the surgery and the recurrence within or out the tumor bed overall survival: the interval from the surgery and the death or lost of follow-up'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['postoperative', 'conformal', 'radiotherapy', 'thymoma'], 'conditions': ['Thymoma']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether postoperative conformal radiotherapy are effective in the treatment of Masaoka stage II-III B type thymoma.', 'detailedDescription': 'The role of postoperative radiotherapy in thymoma is controversial. Some retrospective studies were for the radiotherapy, but others were against. However, more inherent biases existed in these trials. Resection, Masaoka stage and pathology were widely accepted as the prognostic factors for thymoma. Furthermore, the frequency of local failure after radical resection was still high in Masaoka stage II-III B type thymoma. With the conformal technique appearing, conformal radiotherapy can escalate the dose without increasing the risk of normal tissue toxicities.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18-75, Zubrod-ECOG-WHO 0-2, the interval of surgery to radiotherapy \\< 2months, Masaoka stage II-III and WHO B type thymoma\n\nExclusion Criteria:\n\n* No second primary tumor, no serious comorbidity, no neoadjuvant anticancer treatment, no adjuvant chemotherapy.'}, 'identificationModule': {'nctId': 'NCT02014805', 'briefTitle': 'Postoperative Conformal Radiotherapy for Stage II-III B Type Thymoma', 'organization': {'class': 'UNKNOWN', 'fullName': 'ChineseAMS'}, 'officialTitle': 'A Multi-institutional, Randomized Controlled Trial of Postoperative Conformal Radiotherapy for Stage II-III B Type Thymoma', 'orgStudyIdInfo': {'id': 'POCRT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'radiotherapy', 'description': 'postoperative conformal radiotherapy for Masaoka stage II-III B type thymoma', 'interventionNames': ['Radiation: radiotherapy']}, {'type': 'NO_INTERVENTION', 'label': 'observation', 'description': 'no treatment after radical resection for thymoma'}], 'interventions': [{'name': 'radiotherapy', 'type': 'RADIATION', 'description': 'postoperative conformal radiotherapy for Masaoka stage II-III B type thymoma', 'armGroupLabels': ['radiotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100021', 'city': 'Beijing', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Shuting Li, Ph.D.', 'role': 'CONTACT', 'email': 'cancergcp@163.com', 'phone': '8610-87788495'}, {'name': 'Qinfu Feng, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Cancer hospital, Chineses Academy of Medical Sciences', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Qinfu Feng, M.D.', 'role': 'CONTACT', 'email': '13811300221@163.com', 'phone': '8610-87788503'}, {'name': 'Ye Zhang, M.D.', 'role': 'CONTACT', 'email': 'drzye1983@163.com', 'phone': '8610-87788504'}], 'overallOfficials': [{'name': 'Qinfu Feng, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cancer Institute and Hospital, Chinese Academy of Medical Sciences'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese Academy of Medical Sciences', 'class': 'OTHER'}, 'collaborators': [{'name': 'Beijing Hospital', 'class': 'OTHER_GOV'}, {'name': "309th Hospital of Chinese People's Liberation Army", 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Attending physician', 'investigatorFullName': 'Ye Zhang', 'investigatorAffiliation': 'Chinese Academy of Medical Sciences'}}}}