Ignite Creation Date:
2025-12-25 @ 2:55 AM
Ignite Modification Date:
2025-12-26 @ 1:36 AM
Study NCT ID:
NCT06037733
Status:
RECRUITING
Last Update Posted:
2024-03-15
First Post:
2023-09-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Primary Tumor Radiotherapy Omitting CTV for Patients With Advanced NSCLC Responded to Immunotherapy and Chemotherapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 134}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-03-13', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2027-10-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-13', 'studyFirstSubmitDate': '2023-09-07', 'studyFirstSubmitQcDate': '2023-09-07', 'lastUpdatePostDateStruct': {'date': '2024-03-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03-13', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'grade 2 or more pneumonitis', 'timeFrame': 'up to 6 months'}], 'secondaryOutcomes': [{'measure': 'local/regional control rate', 'timeFrame': 'up to 12 months'}, {'measure': 'Progress free survival', 'timeFrame': 'up to 12 months'}, {'measure': 'grade 3 or more pneumonitis', 'timeFrame': 'up to 6 months'}, {'measure': 'grade 3 or more esophagitis', 'timeFrame': 'up to 6 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['omitting CTV'], 'conditions': ['Advanced Non-Small Cell Squamous Lung Cancer', 'Radiotherapy', 'Immunotherapy']}, 'descriptionModule': {'briefSummary': 'The aim of this randomized study is to investigate pneumonitis, local tumor control, and survival outcomes of primary tumor radiotherapy omitting CTV for patients with advanced NSCLC responded to immunotherapy and chemotherapy', 'detailedDescription': 'Studies have confirmed that systemic therapy combined with primary tumor radiotherapy can improve symptoms and prolong survival of advanced NSCLC. Our previous sturdy indicated that patients who received immunotherapy and subsequent radiotherapy suffered higher proportion of pneumonitis. Patients suffered grade 2 or more pneumonitis have worse prognosis. It is urged to optimize the radiotherapy dose and target volume for patients treated with immunotherapy and radiotherapy. According to retrospective and prospective studies, omitting primary tumor CTV radiation therapy showed no reduction in local control and survival for locally advanced NSCLC. It is postulated that omitting CTV radiation for patients responded to therapy with immunotherapy and chemotherapy will have less pneumonitis without sacrificing the local control rate. Omitting CTV may also retain better immune function which will facilitate the immunotherapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Histologically or cytologically confirmed advanced non-small cell lung cancer (according to the 8th edition of the TNM cancer staging system of AJCC and UICC);\n2. After over two cycles of chemotherapy combined with immunotherapy, the efficacy was CR, PR or SD (with a decreasing trend);\n3. Age 18 to 80 years old, performance status 0-1;\n4. measurable or evaluable lesions;\n5. Survival expectancy is not less than 6 months;\n6. adequate cardiac, pulmonary, renal, and hepatic and bone marrow function\n\nExclusion Criteria:\n\n1. tumor progress after therapy with immunotherapy and chemotherapy\n2. EGFR, ALK, or ROS1 mutation;\n3. Previous thoracic radiotherapy;\n4. grade 2 or more immune-related adverse events after induction immunotherapy\n5. Previous malignancies (except stage I non-melanic skin cancer or cervical carcinoma in situ);\n6. Pregnant or lactating women\n7. undergoing other clinical trials;\n8. Have serious comorbidities, including myocardial infarction, severe arrhythmia, severe cerebrovascular disease, ulcer disease, psychosis and uncontrollable diabetes;\n9. Patients with HIV positive and undergoing antiviral therapy;\n10. Active tuberculosis'}, 'identificationModule': {'nctId': 'NCT06037733', 'briefTitle': 'Primary Tumor Radiotherapy Omitting CTV for Patients With Advanced NSCLC Responded to Immunotherapy and Chemotherapy', 'organization': {'class': 'OTHER', 'fullName': 'Hubei Cancer Hospital'}, 'officialTitle': 'Primary Tumor Radiotherapy Omitting Clinical Target Volume for Patients With Advanced Non Small Cell Lung Cancer Responded to Immunotherapy and Chemotherapy', 'orgStudyIdInfo': {'id': 'OMCTV-HC-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CTV-omitted', 'description': 'CTV was omitted for primary tumor radiotherapy for advanced NSCLC who responded to therapy with immunotherapy and chemotherapy.', 'interventionNames': ['Radiation: CTV omitted or delineated']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'CTV-delineated', 'description': 'CTV was delineated for primary tumor radiotherapy for advanced NSCLC who responded to induction therapy with immunotherapy and chemotherapy.', 'interventionNames': ['Radiation: CTV omitted or delineated']}], 'interventions': [{'name': 'CTV omitted or delineated', 'type': 'RADIATION', 'description': 'Patients who responded to the therapy (immunotherapy and chemotherapy) were randomly (1:1) assigned into CTV-omitted radiotherapy group or CTV-delineated radiotherapy group.', 'armGroupLabels': ['CTV-delineated', 'CTV-omitted']}]}, 'contactsLocationsModule': {'locations': [{'zip': '430079', 'city': 'Wuhan', 'state': 'Hubei', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Han Guang, MD', 'role': 'CONTACT'}, {'name': 'Han Guang, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hubei Cancer Hospital', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}], 'centralContacts': [{'name': 'Guang Han, PhD', 'role': 'CONTACT', 'email': 'hg7913@hotmail.com', 'phone': '+86 13886048178'}], 'overallOfficials': [{'name': 'Guang Han, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Radiation Oncology, Hubei Cancer Hospital, Tongji Medical College, Huazhong University of Science and Technology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hubei Cancer Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of the department of Radiotherapy Oncology', 'investigatorFullName': 'HAN GUANG', 'investigatorAffiliation': 'Hubei Cancer Hospital'}}}}