[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100347441":3},{"organization":4,"armGroups":7,"interventions":26,"overallOfficials":34,"centralContacts":39,"locations":49,"responsibleParty":72,"collaborators":75,"id":78,"slug":79,"hasResults":80,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":18,"eligibilityCriteria":84,"healthyVolunteers":80,"sex":85,"minAge":86,"maxAge":87,"enrollmentInfo":88,"targetDuration":18,"studyType":91,"phases":92,"briefSummary":94,"conditions":95,"keywords":97,"overallStatus":52,"whyStopped":18,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":117},{"fullName":5,"class":6},"Instituto Nacional de Cancerologia de Mexico","OTHER",[8,14,19,23],{"label":9,"type":10,"description":11,"interventionNames":12},"QT\u002FRT + Budesonide","EXPERIMENTAL","Patients are receiving chemotherapy (QT) and radiotherapy (RT) plus inhaled Budesonide with space chamber at 400 mcg given twice daily initiating after the first dose of RT and continuing until pneumonitis development or 12 months completed.",[13],"Drug: Inhaled budesonide",{"label":15,"type":16,"description":17,"interventionNames":18},"QT\u002FRT + No medication","NO_INTERVENTION","Patients are receiving chemotherapy (QT) and radiotherapy (RT) without intervention therapy and followed during 12 months.",null,{"label":20,"type":10,"description":21,"interventionNames":22},"Target drug\u002FRT + Budesonide","Patients are receiving target therapy and radiotherapy (RT) plus inhaled Budesonide with space chamber at 400 mcg given twice daily initiating after the first dose of RT and continuing until pneumonitis development or 12 months completed.",[13],{"label":24,"type":16,"description":25,"interventionNames":18},"Target drug\u002FRT + No medication","Patients are receiving target treatment and radiotherapy (RT) without intervention therapy and followed during 12 months.",[27],{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"DRUG","Inhaled budesonide","Patients will use inhaled budesonide (Numark) with space chamber at 400 mcg given twice daily initiating after the first dose of RT and continuing until pneumonitis development or 12 months completed.",[9,20],[33],"Numark",[35],{"name":36,"affiliation":37,"role":38},"Oscar Arrieta, MD MSc","Instituto Nacional de Cancerologia, Mexico","PRINCIPAL_INVESTIGATOR",[40,45],{"name":36,"role":41,"phone":42,"phoneExt":43,"email":44},"CONTACT","015556280400","71100","ogarrieta@gmail.com",{"name":46,"role":41,"phone":42,"phoneExt":47,"email":48},"Diana Flores","71101","clinicacancerpulmonincan@gmail.com",[50,66],{"facility":51,"status":52,"city":53,"state":18,"zip":54,"country":55,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":62,"contacts":63},"Instituto Nacional de Cancerologia","RECRUITING","Mexico City","14080","Mexico","MX",{"type":58,"coordinates":59},"Point",[60,61],-99.12766,19.42847,{"lat":61,"lon":60},[64,65],{"name":36,"role":41,"phone":42,"phoneExt":43,"email":44},{"name":46,"role":41,"phone":42,"phoneExt":47,"email":48},{"facility":67,"status":68,"city":53,"state":18,"zip":54,"country":55,"countryCode":56,"cosmosGeoPoint":69,"geoPoint":71,"contacts":18},"Instituto Nacional de Enfermedades Respiratorias","ACTIVE_NOT_RECRUITING",{"type":58,"coordinates":70},[60,61],{"lat":61,"lon":60},{"type":38,"investigatorFullName":73,"investigatorTitle":74,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"Oscar Gerardo Arrieta Rodríguez","Head of the Thoracic Oncology unit",[76],{"name":67,"class":77},"OTHER_GOV","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":89,"type":90},72,"ESTIMATED","INTERVENTIONAL",[93],"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.",[96],"Radiation Pneumonitis",[98,99,100,101,102,103,104,105,106,107],"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","2026-04-06",{"date":110,"type":111},"2026-04-08","ACTUAL",{"date":113,"type":111},"2018-09-01",{"date":115,"type":90},"2027-12-01",{"name":5,"class":6},2]