[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"radiation-pneumonitis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:radiation-pneumonitis":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,9,0,[8,52,83,117,144,176,203,232,255],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":51},"100347441","phase-2-prophylactic-inhaled-steroids-to-reduce-radiation-pneumonitis-frequency-and-severity-in-lung-cancer-patients-100347441",false,"NCT03803787","Prophylactic Inhaled Steroids to Reduce Radiation Pneumonitis Frequency and Severity in Lung Cancer Patients","Prophylactic Inhaled Steroids to Reduce Radiation Pneumonitis Frequency and Severity in Non-small Cell Lung Cancer Patients","Inclusion Criteria:\n\n* Patients with non-small cell lung cancer (NSCLC) with unresectable locally advanced or metastatic disease (IIIA, IIIB or IV) of the classification tumor node, metastasis (TNM) of malignant lung tumors, 7th edition.\n* NSCLC patients candidates for concomitant treatment (chemotherapy plus radiotherapy or target therapy plus radiotherapy).\n* Evidence of measurable disease\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2, Karnofsky 70-100.\n* Life expectancy of \\> 4 months at the time of screening\n* Patients with the ability to comply with the study and follow-up procedures.\n* Patients with previous surgery less than four weeks.\n* Must be willing and able to give signed informed consent and, in the opinion of the Investigator, to comply with the protocol tests and procedures.\n\nExclusion Criteria:\n\n* Unstable systemic disease: active infection, heart, liver, kidney or metabolic disease; including uncontrolled chronic lung disease.\n* Patients treated with systemic or inhaled corticosteroids.\n* Patients of reproductive age without a family planning method, pregnant or lactating.\n* Previous diagnosis of Pneumonitis with toxicity grade ≥ 2 by CTCAE v4.0 or RTOG scale.\n* Patients with disease progression.\n* Inspiratory flow \\\u003C 90 liters \u002F min.\n* Discontinue of Treatment","ALL","18 Years","75 Years",{"count":20,"type":21},72,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This randomized clinical study aims to assess whether prophylactic treatment with inhaled steroids in patients with locally advanced or concomitantly treated non-small cell lung carcinoma who are candidates for combination treatment with QT\u002FRT or IMT + QT\u002FRT.\n\nThe main questions it aims to answer are:\n\nWhether prophylactic treatment decreases the severity of NPR on CTCAE v4.0 and RTOG scales.\n\nWhether inhaled steroid use modifies the response to radiation therapy treatment compared to patients who do not receive prophylactic inhaled steroids.",[27],"Radiation Pneumonitis",[29,30,31,32,33,34,35,36,37,38],"Non-Small Cell Lung Cancer","Radiation Pneumonia","Lung cancer treatment","Respiratory Tract Neoplasms","Radiation fibrosis","Thoracic Neoplasms","Lung Diseases","Radiation Injury with Fibrosis","Radiation Fibrosis of Lung","Lung Injury","RECRUITING","2026-04-06",{"date":42,"type":43},"2026-04-08","ACTUAL",{"date":45,"type":43},"2018-09-01",{"date":47,"type":21},"2027-12-01",{"name":49,"class":50},"Instituto Nacional de Cancerologia de Mexico","OTHER",2,{"id":53,"slug":54,"hasResults":11,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":58,"eligibilityCriteria":59,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":60,"targetDuration":4,"studyType":22,"phases":62,"briefSummary":64,"conditions":65,"keywords":70,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":51},"100414454","functional-lung-avoidance-spect-guided-radiation-therapy-of-lung-cancer-100414454","NCT04676828","Functional Lung Avoidance SPECT-guided Radiation Therapy of Lung Cancer","Functional Lung Avoidance SPECT-guided (ASPECT) Radiation Therapy for Lung Cancer Patients: Phase II Randomised Clinical Trial","ASPECT","Inclusion Criteria:\n\n* histologically verified lung cancer (small-cell and non-small cell lung cancer)\n* referred for radiotherapy with curative intent\n* radiation dose of 60-66 Gy given in 2-Gy fractions, other dose levels and fractionation schedules accepted, as per site standard\n* concurrent chemotherapy is accepted\n* patients with oligometastatic disease are allowed, where metastasis have been ablated with surgery or radiotherapy\n* receiving (chemo)-radiotherapy to the thoracic disease with curative intent\n* adults over 18, that have given oral and written informed consent before patient registration.\n\nExclusion Criteria:\n\n* concurrent immunotherapy\n* previous radiotherapy to the thorax\n* other uncontrolled malignancies; any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol",{"count":61,"type":21},90,[63],"NA","Study aims to determine if functional lung avoidance based on perfusion single photon emission (SPECT)\u002FCT scan, improves toxicity outcomes for patients with advanced lung cancer undergoing chemo-radiotherapy. Functional avoidance implies a dose plan that takes functional distribution in the lung into account, and avoids highly functional lung volumes sparing them from radiation.",[66,67,27,68,69],"Lung Cancer","Radiation-Induced Disorder","Pulmonary Disease","Lung Function Decreased",[71,72,73],"radiation-induced lung toxicity","functional avoidance methodology","radiation therapy of lung cancer","2026-02-22",{"date":76,"type":43},"2026-02-24",{"date":78,"type":43},"2021-12-01",{"date":80,"type":21},"2028-12-01",{"name":82,"class":50},"University of Aarhus",{"id":84,"slug":85,"hasResults":11,"nctId":86,"briefTitle":87,"officialTitle":87,"acronym":88,"eligibilityCriteria":89,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":90,"enrollmentInfo":91,"targetDuration":4,"studyType":22,"phases":93,"briefSummary":94,"conditions":95,"keywords":98,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":116},"100619055","functional-lung-avoidance-radiotherapy-guided-by-4dct-pulmonary-ventilation-function-imaging-a-prospective-single-arm-clinical-study-100619055","NCT07339644","Functional Lung Avoidance Radiotherapy Guided by 4DCT Pulmonary Ventilation Function Imaging: A Prospective Single-arm Clinical Study","4DCT-FLAR","Inclusion Criteria:\n\n* Age 18 to 85 years (inclusive); any sex.\n* Diagnosed lung malignancy requiring thoracic radiotherapy (e.g., non-small cell lung cancer, small cell lung cancer, or pulmonary metastases).\n* Planned to receive thoracic radiotherapy using either conventionally fractionated IMRT\u002FVMAT or stereotactic body radiotherapy (SBRT), and able to complete pre-treatment 4DCT simulation suitable for generating a ventilation map.\n* Adequate baseline organ function and clinically judged able to tolerate radiotherapy; ECOG performance status 0-1.\n* No absolute contraindication to pulmonary function testing; patients with moderate COPD or impaired lung function may be included if the treating team judges radiotherapy to be tolerable.\n* Able to comply with treatment and follow-up assessments.\n* Written informed consent provided.\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding women. Women of childbearing potential must have pregnancy excluded prior to radiotherapy per institutional practice.\n* Age \\\u003C18 or \\>85 years.\n* Uncontrolled severe cardiopulmonary disease or other severe comorbidities that make radiotherapy excessively high risk (e.g., decompensated heart failure, unstable cardiopulmonary status, active severe pulmonary infection).\n* Prior high-dose thoracic radiotherapy to the same region such that safe re-irradiation is not feasible.\n* Concurrent other active\u002Fadvanced malignancy requiring priority treatment that would confound study outcomes.\n* Recent participation in another interventional clinical trial or concurrent investigational therapy judged likely to interfere with this study's endpoints.\n* Severe psychiatric, cognitive, or other conditions that prevent cooperation with radiotherapy and\u002For scheduled follow-up.\n* Inadequate 4DCT image quality or inability to generate\u002Fvalidate the 4DCT ventilation map required for functional-lung-guided planning.\n* Any other condition deemed unsuitable by the investigators in the interest of participant safety.","85 Years",{"count":92,"type":21},100,[63],"This prospective, single-center, single-arm study will evaluate the feasibility and safety of 4DCT ventilation functional imaging-guided functional lung avoidance radiotherapy (FLAR) in patients with lung malignancies receiving IMRT radiotherapy.\n\nAll participants will undergo 4DCT simulation as part of routine radiotherapy preparation. A ventilation map will be generated from 4DCT data, and the top 80% ventilation region will be defined as the high-function lung. This structure will be imported into the treatment planning system to create an FLAR plan that prioritizes sparing of high-function lung while maintaining target coverage (PTV D95%) and meeting standard dose constraints for organs at risk. A conventional anatomic plan (without functional guidance) will also be created for paired, within-patient dosimetric comparison.\n\nThe primary outcome is improvement in dosimetric sparing of the high-function lung (V10, V20, V30, and mean lung dose). Secondary outcomes include the incidence of grade ≥2 radiation pneumonitis (CTCAE v5.0), changes in pulmonary function (e.g., FEV1 and DLCO), and lung-related quality-of-life scores. Assessments will be performed mid-treatment (after 15 fractions), at the end of radiotherapy (after 30 fractions), and at 1, 3, 6, and 12 months after radiotherapy. The study plans to enroll 100 participants and follow each participant for 12 months.",[96,27,97],"Lung Cancer (Including Metastatic Cancer)","Radiation-induced Lung Injury",[99,100,101,102,103,104,105,106],"Functional lung avoidance radiotherapy","4DCT ventilation imaging","Functional lung imaging (FLI)","Dose-volume histogram (DVH)","High-function lung","Radiotherapy planning optimization","Radiation pneumonitis","Pulmonary function","2026-02-05",{"date":109,"type":43},"2026-02-09",{"date":111,"type":43},"2025-10-24",{"date":113,"type":21},"2027-12-24",{"name":115,"class":50},"The Second Affiliated Hospital of Chongqing Medical University",1,{"id":118,"slug":119,"hasResults":11,"nctId":120,"briefTitle":121,"officialTitle":121,"acronym":122,"eligibilityCriteria":123,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":124,"targetDuration":4,"studyType":126,"phases":4,"briefSummary":127,"conditions":128,"keywords":129,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":133,"lastUpdatePostDateStruct":134,"startDateStruct":136,"completionDateStruct":138,"leadSponsor":140,"locationsCount":143},"100558916","single-cell-sequencing-analysis-of-radiation-pneumonitis-signals-in-patients-treated-for-cancer-with-radiotherapy-100558916","NCT06557343","Single-Cell Sequencing Analysis of Radiation Pneumonitis Signals In Patients Treated For Cancer With Radiotherapy","SPITFIRE","Inclusion Criteria:\n\n* Age over 18 years\n* Patient has received thoracic radiotherapy and has clinical or radiological features in fitting with a diagnosis of Radiation Pneumonitis (onset one to four months post-RT with breathlessness, especially exertional, cough, chest discomfort, which is persistent over weeks, a chest x-ray \\[CXR\\] may demonstrate patchy or widespread opacification although can be normal.)\n* Must be ambulant, oxygen independent with SpO2 \\>92% on air and haemodynamically stable to be considered safe for a bronchoscopy.\n* Willing to undergo and likely able to tolerate bronchoscopy, ie. Can lie flat without compromising ventilation, and able to consent to the ELFMAN Protocol and SPITFIRE trial.\n\nExclusion Criteria:\n\n* Contraindication to bronchoscopy, ie. Previously not tolerated, unable to lie flat, Sp02 \\\u003C92% on air\n* Patient requires admission or oxygen dependant\n* Test positive for Covid-19 within the preceding six weeks to enrolment",{"count":125,"type":21},5,"OBSERVATIONAL","Patients with signs of radiation induced lung inflammation, who are referred for a clinical bronchoscopy for investigation, will have a sample sent for single cell sequencing. This is a novel technique which allows for identification of which cells are present and what they are doing. This hopes to better understand radiation pneumonitis, a dose-limiting toxicity in cancer treatment which can be highly morbid and even fatal.",[27],[130,131,132],"radiation pneumonitis","cancer","single cell sequencing","2026-01-08",{"date":135,"type":43},"2026-01-09",{"date":137,"type":43},"2024-10-25",{"date":139,"type":21},"2026-12",{"name":141,"class":142},"NHS Lothian","OTHER_GOV",3,{"id":145,"slug":146,"hasResults":11,"nctId":147,"briefTitle":148,"officialTitle":149,"acronym":150,"eligibilityCriteria":151,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":152,"targetDuration":4,"studyType":22,"phases":154,"briefSummary":156,"conditions":157,"keywords":164,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":168,"lastUpdatePostDateStruct":169,"startDateStruct":171,"completionDateStruct":173,"leadSponsor":174,"locationsCount":116},"100467364","early-phase-1-fapi-pet-for-lung-fibrosis-100467364","NCT05365802","FAPI PET for Lung Fibrosis","PET Study of 68Ga-FAPi-46 in Patients With Interstitial Lung Disease: an Exploratory Biodistribution Study With Histopathology Validation.","FAPI ILD","Inclusion criteria\n\n* Patients with ILD confirmed by CT at time of staging\n* Patients who have initiated or will initiate a new ILD medication with 3 months of enrollment OR Patients who are scheduled to undergo tissue biopsy or surgery of the lung\n* Patients are ≥ 18 years old at the time of the radiotracer administration\n* Patient can provide written informed consent\n\nExclusion criteria\n\n* Patient is pregnant or nursing\n* Patients with active infectious lung disease\n* Patients not expected to comply with the protocol requirements, not able to understand or follow trial procedures",{"count":153,"type":21},30,[155],"EARLY_PHASE1","This is a prospective exploratory biodistribution study in patients with interstitial lung disease (ILD).\n\nThe purpose of this research study is to determine where and to which degree the FAPI tracer (68Ga-FAPI-46) accumulates in normal and fibrotic lung tissues of patients with interstitial lung disease.\n\nThe study will include patients with interstitial lung disease who have or will initiate a new ILD medication OR will undergo tissue biopsy or surgery of the lung.\n\nThe study will include 30 patients, the upper limit for PET imaging studies conducted under the Radioactive Drug Research Committee (RDRC) purview.\n\nParticipants will be injected with up to 7 mCi of 68-GaFAPi and will undergo one PET\u002FCT scan and one High Resolution CT of the lungs.\n\nThe study is sponsored by Ahmanson Translational Theranostic Division at UCLA.",[158,159,160,161,27,162,163],"Interstitial Lung Disease","Idiopathic Interstitial Pneumonias","Drug-Induced Pneumonitis","Hypersensitivity Pneumonitis","Pneumoconiosis","Pulmonary Fibrosis",[165,166,167],"interstitial lung disease","pulmonary fibrosis","68Ga-FAPi-46","2025-06-30",{"date":170,"type":43},"2025-07-03",{"date":172,"type":43},"2021-11-16",{"date":139,"type":21},{"name":175,"class":50},"University of California, Los Angeles",{"id":177,"slug":178,"hasResults":11,"nctId":179,"briefTitle":180,"officialTitle":181,"acronym":4,"eligibilityCriteria":182,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":183,"enrollmentInfo":184,"targetDuration":4,"studyType":22,"phases":186,"briefSummary":187,"conditions":188,"keywords":189,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":194,"lastUpdatePostDateStruct":195,"startDateStruct":197,"completionDateStruct":199,"leadSponsor":201,"locationsCount":116},"100453819","hyperbaric-oxygen-in-the-prevention-of-radiation-pneumonitis-100453819","NCT05189496","Hyperbaric Oxygen in the Prevention of Radiation Pneumonitis","Study on the Effectiveness and Safety of Hyperbaric Oxygen Therapy for Preventing Radiation Pneumonitis Caused by Radiotherapy and Chemotherapy of Breast Cancer","Inclusion Criteria:\n\n* (1) Volunteer to participate and sign informed consent in writing. (2) Past pathological diagnosis of breast cancer followed by radical treatment\u002Fsurgery for breast cancer, followed by adjuvant chemotherapy followed by radiotherapy.\n\n  (3) Excluding patients with simple neck lymph node recurrence and patients with distant metastases.\n\n  (4) There is no secondary malignant tumor in other parts. (5) Age at entry ≥ 18 years old and ≤ 70 years old, both male and female. (6) The Eastern Cooperative Oncology Group (ECOG) has a performance status score of 0 or 1.\n\n  (7) The expected survival period is ≥2 years. (8) There was no acute radiation lung injury in chest CT examination before and after radiotherapy\n\nExclusion Criteria:\n\n* (1) Contraindications to hyperbaric oxygen therapy: lung disease (severe chronic obstructive airway disease, bullous lung disease, acute or chronic lung infection, uncontrolled asthma, untreated pneumothorax), in the past History of ear surgery, middle ear disease (eustachian tube dysfunction, recurrent dizziness), eye disease (retinal detachment).\n\n  (2) Have received hyperbaric oxygen therapy in the past. (3) Radiation pneumonia had occurred at the time of enrollment or before receiving hyperbaric oxygen therapy.\n\n  (4) Women who are pregnant or breastfeeding. (5) Patients who have not completed comprehensive breast cancer treatment due to disease progression, intolerable side effects, abandonment of treatment and other reasons.\n\n  (8) Patients who need mechanical ventilation support. (9) Patients who cannot follow and understand simple commands. (10) Patients with disorientation and mental disorders.","70 Years",{"count":185,"type":21},380,[63],"Radiotherapy is one of the important treatments to improve the survival rate of breast cancer patients, but also has the risk of radiation lung injury, which can develop into pulmonary fibrosis. Hyperbaric oxygen can improve the tissue after radiation by promoting the function of vascular endothelial cells and fibroblasts, and reducing the secretion of inflammatory factors, thereby inhibiting the process of fibrosis and fiber atrophy after radiotherapy, and promoting tissue repair. Therefore, it has the potential value of treating chronic radiation injury. We aim to investigate whether hyperbaric oxygen treatment can reduce the incidence of radiation pneumonia and improve patients' quality of life, and to evaluate its safety and the impact on the patients' long-term survival outcomes.",[27],[190,27,191,192,193],"Hyperbaric Oxygen","Breast Cancer","Radiotherapy","Chemotherapy","2025-02-10",{"date":196,"type":43},"2025-02-12",{"date":198,"type":43},"2022-03-01",{"date":200,"type":21},"2026-12-31",{"name":202,"class":50},"Guangdong Provincial People's Hospital",{"id":204,"slug":205,"hasResults":11,"nctId":206,"briefTitle":207,"officialTitle":208,"acronym":209,"eligibilityCriteria":210,"healthyVolunteers":11,"sex":211,"minAge":17,"maxAge":4,"enrollmentInfo":212,"targetDuration":4,"studyType":126,"phases":4,"briefSummary":214,"conditions":215,"keywords":218,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":222,"lastUpdatePostDateStruct":223,"startDateStruct":225,"completionDateStruct":227,"leadSponsor":229,"locationsCount":116},"100521401","radiotherapy-exposed-lung-injury-effect-on-functioning---cohort-100521401","NCT06069115","Radiotherapy Exposed Lung Injury: Effect on Functioning - Cohort","Investigation of Oxygen Metabolism and Reserve Capabilities of Cardiovascular and Respiratory Systems in Patients with Malignant Neoplasms of the Breast in the Course of Complex Treatment","RELIEF-COHORT","Inclusion Criteria:\n\n* established diagnosis of malignant breast neoplasm;\n* signed informed voluntary consent of the patient to participate in the study.\n\nExclusion Criteria:\n\n* contraindications to the use of inhaled corticosteroids (presence of active or inactive pulmonary tuberculosis, fungal, viral or bacterial infection of the respiratory organs);\n* lung diseases requiring baseline therapy with glucocorticosteroids (chronic obstructive pulmonary disease, bronchial asthma);\n* mental and\u002For musculoskeletal impairments that make it impossible to adequately perform the exercise test, cooperate with the patient and interpret the results;\n* conditions and diseases requiring emergency surgical intervention and\u002For observation and treatment in an ICU setting;\n* patient's refusal to participate in this clinical trial at any stage of the study.","FEMALE",{"count":213,"type":21},200,"Prospective cohort research to study the state of oxygen metabolism, reserve capabilities of cardiovascular and respiratory systems in patients with breast cancer to create a program of prevention and rehabilitation of lung damage in the process of complex treatment of the disease.\n\nThe aim of the study is to study the dynamics of oxygen metabolism and reserve capabilities of cardiovascular and respiratory systems in the process of complex treatment of breast neoplasias.\n\nObjectives of the study:\n\n1. Explore the dynamics of pulmonary ventilation and gas exchange disorders in patients with breast cancer in the course of radiation therapy\n2. Establish an algorithm for risk stratification of post-radiation disorders of pulmonary ventilation and gas exchange in patients with breast cancer.\n3. Analyze the prognostic significance of cardiopulmonary exercise testing in assessing the cardiotoxic effect of chemo- and radiation therapy in patients with breast cancer.\n4. Analyze the influence of post-radiation disorders of pulmonary ventilation and gas exchange on the quality of life and psycho-emotional status of patients with breast cancer.\n5. Develop a fundamental basis for the program of prevention and rehabilitation of post-radiation lung damage in patients with breast neoplasias based on the study of individual parameters of oxygen metabolism and reserve capabilities of cardiovascular and respiratory systems.\n\nAll participants go through 5-week radiation therapy in standard protocol, will have investigation of their lung functioning by spirography and assessment of pulmonary diffusion capacity, cardiopulmonary stress tests and CT-scan on the lungs before radiotherapy course. Researchers will analyze such parameters as stage of the disease, surgery type, all patient's medications, complications, nutritional status, psychological status.",[216,30,27,217],"Breast Neoplasms","Radiation Induced Fibrosis",[219,220,221],"breast cancer","radiation therapy","radiation induced lung fibrosis","2025-02-07",{"date":224,"type":43},"2025-02-11",{"date":226,"type":43},"2023-07-18",{"date":228,"type":21},"2026-07-18",{"name":230,"class":231},"Meshalkin Research Institute of Pathology of Circulation","NETWORK",{"id":233,"slug":234,"hasResults":11,"nctId":235,"briefTitle":236,"officialTitle":237,"acronym":4,"eligibilityCriteria":238,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":239,"targetDuration":4,"studyType":126,"phases":4,"briefSummary":241,"conditions":242,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":245,"lastUpdatePostDateStruct":246,"startDateStruct":248,"completionDateStruct":250,"leadSponsor":252,"locationsCount":254},"100559913","nintedanib-for-the-prevention-of-radiation-pneumonia-in-unresectable-nsclc-100559913","NCT06570317","Nintedanib for the Prevention of Radiation Pneumonia in Unresectable NSCLC","Prospective, Multicentre Phase II Clinical Study of Nintedanib for the Prevention of Radiation Pneumonia in Unresectable NSCLC","Inclusion Criteria:\n\n* 1\\) Men or women who are over 18 years old (including 18 years old) when signing the informed consent form;\n* 2\\) Non-small cell lung cancer was confirmed by histology and could not be resected, and EGFR\u002FALK driver gene was confirmed negative by gene mutation examination;\n* 3\\) At least one measurable lesion with imaging examination (according to RECIST1.1) is examined by spiral CT or MR, and the length and diameter of the lesion are ≥ 10 mm;\n* 4\\) within 3 days before treatment, the score according to ECOG is 0 \\~ 1;\n* 5\\) Life expectancy ≥3 months;\n* 6)The vital organs function well,\n* 7)The subjects volunteered to join the study and signed the informed consent form, with good compliance and cooperation with the follow-up.\n\nExclusion Criteria:\n\n* 1\\) Complicated with severe respiratory diseases: pulmonary fibrosis, active tuberculosis, etc.\n* 2)Persons with mental disorder, blood system diseases, autoimmune diseases and serious primary diseases of heart, brain, liver and kidney;\n* 3\\) Hemorrhagic events that require blood transfusion, invasive intervention or hospitalization occur within 3 months before the first administration, or there are bleeding symptoms and need intervention treatment (such as hemoptysis, hematuria and bloody stool), or high-risk factors with bleeding risk (such as tumor surrounding or invading important blood vessels, obvious necrosis or cavity around tumor, esophageal varices, etc.);\n* 4\\) Thrombosis or embolic diseases, abnormal blood coagulation function and bleeding tendency;\n* 5\\) Known or suspected to be allergic to the study drug and its auxiliary materials;\n* 6\\) The baseline pregnancy test of pregnant and lactating women or fertile women is positive.\n* 7\\) According to the researcher's judgment, the subjects have other factors that may lead to the forced termination of this study.",{"count":240,"type":21},40,"This study is aimed at patients with unresectable NSCLC who take nintedanib during sequential radiotherapy to explore the incidence of radiation pneumonitis above grade 2 in the nintedanib combined with radiotherapy mode and observe safety. And will further explore the progression-free survival (PFS) and overall survival (OS) of patients treated with nintedanib in combination with radiotherapy and immunotherapy.\n\nPrimary objective: To evaluate the safety of nintedanib combined with sequential radiotherapy in patients with unresectable NSCLC and the incidence of radiation pneumonitis above grade 2. Secondary objective: To evaluate the changes in lung function, progression-free survival (PFS) and overall survival (OS) in patients with unresectable NSCLC after nintedanib combined with sequential radiotherapy.\n\nPatients need to receive induction therapy, chemotherapy and\u002For immunotherapy for at least one cycle. Then they will receive sequential radiotherapy and nintedanib for 6 months. Finally, they will receive immunotherapy maintenance therapy for 16 cycles.",[243,244,27],"NSCLC","Nintedanib","2024-08-22",{"date":247,"type":43},"2024-08-26",{"date":249,"type":21},"2024-08-24",{"date":251,"type":21},"2026-06-30",{"name":253,"class":50},"Second Hospital of Shanxi Medical University",7,{"id":256,"slug":257,"hasResults":11,"nctId":258,"briefTitle":259,"officialTitle":260,"acronym":4,"eligibilityCriteria":261,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":262,"targetDuration":4,"studyType":126,"phases":4,"briefSummary":264,"conditions":265,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":266,"lastUpdatePostDateStruct":267,"startDateStruct":269,"completionDateStruct":271,"leadSponsor":273,"locationsCount":143},"100473731","a-study-on-predictive-models-and-clinical-outcome-of-radiation-pneumonitis-100473731","NCT05448703","A Study on Predictive Models and Clinical Outcome of Radiation Pneumonitis","A Multicenter Prospective Observational Study on Predictive Models and Clinical Outcome of Radiation Pneumonitis","Inclusion Criteria:\n\n1. Clinical diagnosis of lung cancer by histology\n2. Radiation dose at least 45 Gy\n3. Karnofsky \\>60\n4. Age\\>18\n5. Life expectancy of at least 6 months\n\nExclusion Criteria:\n\n1. Previous thoracic irradiation\n2. Severe cardiopulmonary diseases",{"count":263,"type":21},300,"Radiation pneumonitis is the main dose-limiting toxicity of thoracic radiotherapy, which can affect life quality, survival, and the tumor-controlling effects of patients receiving thoracic radiotherapy.\n\nThe purpose of this study is to:\n\n* Identify biomarkers including serum proteins, gene expression, genetic changes, and epigenetic modifications that determine radiation pneumonitis.\n* Investigate the relationship between radiation pneumonitis and other toxicities induced by radiotherapy.\n* Construct a predictive model for radiation pneumonitis.\n* Evaluate survival and treatment outcome of patients with radiation pneumonitis.",[27],"2022-10-05",{"date":268,"type":43},"2022-10-06",{"date":270,"type":43},"2021-02-25",{"date":272,"type":21},"2026-09-01",{"name":274,"class":50},"Huazhong University of Science and Technology"]