[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05672108":3,"trial-entities:NCT05672108":202,"trial-summary:NCT05672108":209},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":25,"study_type":26,"primary_purpose":27,"phases":28,"enrollment_info":30,"interventions":33,"primary_outcomes":93,"secondary_outcomes":102,"sex":123,"minimum_age":124,"maximum_age":125,"healthy_volunteers":126,"eligibility_criteria":127,"std_ages":157,"locations":160,"central_contacts":190,"overall_officials":193,"references":196,"see_also_links":201},"NCT05672108","22067","Phase II Trial of Lung Chemoemobolization","RECRUITING","2027-10-28","2026-03","2026-03-05","2023-05-12","City of Hope Medical Center","OTHER",true,"This phase II trial evaluates how well transarterial chemoembolization (TACE) works for treating patients with non-small cell lung cancer or lung metastases. TACE is a minimally invasive procedure that involves injecting chemotherapy directly into an artery that supplies blood to tumors, and then blocking off the blood supply to the tumors. Mitomycin (chemotherapy), Lipiodol (drug carrier), and Embospheres (small plastic beads that block off the artery) are injected into the tumor-feeding artery. This traps the chemotherapy inside the tumor and also cuts off the tumor\\'s blood supply. As a result, the tumor is exposed to a high dose of chemotherapy, and is also deprived of nutrients and oxygen. TACE can be effective at controlling or stopping the growth of lung tumors.","PRIMARY OBJECTIVE:\n\nI. To determine safety and efficacy (local progression free survival) of chemoembolization of lung cancer that is chemorefractory, unresectable, and unablatable.\n\nOUTLINE:\n\nPatients receive lung chemoembolization using Lipiodol, mitomycin, and Embospheres. Response to treatment is evaluated on computed tomography (CT) scans.",[18,19,20,21,22,23,24],"Lung Non-Small Cell Carcinoma","Mediastinal Neoplasm","Pleural Neoplasm","Lung Metastases From Any Primary","Endobronchial Metastases","Colon Cancer","Sarcoma",[],"INTERVENTIONAL","TREATMENT",[29],"PHASE2",{"count":31,"type":32},30,"ESTIMATED",[34,49,58,79,85],{"type":35,"name":36,"description":37,"armGroupLabels":38,"otherNames":40},"PROCEDURE","Computed Tomography","Undergo CT",[39],"Lung chemoembolization",[41,42,43,44,45,46,47,48],"CAT","CAT Scan","Computed Axial Tomography","Computerized Axial Tomography","Computerized Tomography","CT","CT Scan","tomography",{"type":50,"name":51,"description":52,"armGroupLabels":53,"otherNames":54},"DRUG","Ethiodized Oil","Given IA",[39],[55,56,57],"Ethiodol","Iodized Oil","Lipiodol",{"type":50,"name":59,"description":52,"armGroupLabels":60,"otherNames":61},"Mitomycin",[39],[62,63,64,65,66,67,68,69,70,71,72,73,74,75,76,77,78],"Ametycine","Jelmyto","MITO","Mito-C","Mito-Medac","Mitocin","Mitocin-C","Mitolem","Mitomycin C","Mitomycin-C","Mitomycin-X","Mitomycine C","Mitosol","Mitozytrex","Mutamycin","Mutamycine","NCI-C04706",{"type":35,"name":80,"description":81,"armGroupLabels":82,"otherNames":83},"Transarterial Chemoembolization","Undergo TACE",[39],[84],"TACE",{"type":86,"name":87,"description":52,"armGroupLabels":88,"otherNames":89},"DEVICE","Tris-acryl Gelatin Microspheres",[39],[90,91,92],"Embospheres","TAGM","Trisacryl Gelatin Microspheres",[94,98],{"measure":95,"description":96,"timeFrame":97},"Local progression free survival","Progression is determined using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. criteria, compared to the scan immediately prior to treatment of that territory, using the 2 largest measurable lesions per treated territory. Local progression-free survival will be estimated using the Kaplan-Meier method.","Time from the initial transarterial chemoembolization (TACE) treatment to progression in a completely treated territory (or touching the border of a completely treated area), or death from any cause, assessed at 6 months",{"measure":99,"description":100,"timeFrame":101},"Incidence of adverse events","Complications will be classified using the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. The rate of complications can be estimated with a standard error of less than 10%. Further, any complication that occurs with a 10% incidence will be observed with greater than 95% probability.","Up to 3 months after the last chemoembolization procedure",[103,107,111,113,116,120],{"measure":104,"description":105,"timeFrame":106},"Objective response rate (best response)","Evaluated on a per-treatment basis, using RECIST version 1.1 criteria.","Within 3 months of treatment",{"measure":108,"description":109,"timeFrame":110},"Overall survival","Will be estimated using the Kaplan-Meier method.","Up to 9 months",{"measure":112,"description":109,"timeFrame":110},"Progression-free survival",{"measure":114,"description":115,"timeFrame":110},"Bronchial versus pulmonary artery blood supply","Percentage of treatments where target tumors were supplied by bronchial artery, non-bronchial systemic artery, or pulmonary artery, based on catheter angiography. Confidence intervals of proportions will be estimated using the equal-tailed Jeffreys prior interval.",{"measure":117,"description":118,"timeFrame":119},"Lipiodol retention in treated tumors","Correlation between lipiodol retention and change in tumor size will be evaluated using Spearman's rank correlation coefficient (rho) and Spearman's test.","4-6 weeks post-procedure",{"measure":121,"description":122,"timeFrame":119},"Growth of TACE targeted lesions versus non-TACE targeted lesions","Percentage change in size (largest diameter) of the largest treated, compared to the largest untreated tumor will be evaluated using the Wilcoxon signed-rank test.","ALL","18 Years",null,false,{"inclusion":128,"exclusion":132,"raw_text":156},[129,130,131],"Lung cancer or lung metastases, with lung, endobronchial, pleural, or mediastinal tumors that are progressing on systemic therapy (or the patient cannot tolerate systemic therapy), and that are not amenable to resection, thermal ablation, or ablative radiation therapy","Lung-dominant disease (majority of active tumor volume is in the chest)","At least 18 years old",[133,134,135,136,137,138,139,140,141,142,143,144,145,146,147,148,149,150,151,152,153,154,155],"Eastern Cooperative Oncology Group (ECOG) performance status \\> 2","Oxygen saturation \\< 92% on room air","Forced expiratory volume in 1 second (FEV1) \\< 60%","No measurable treatable disease, per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (for example, unable to measure tumor size on CT, or lung nodules are all \\< 1 cm)","Life expectancy \\< 6 months","Pulmonary hypertension (diagnosed or suspected on echocardiography, CT, magnetic resonance imaging \\[MRI\\], or direct pressure measurement)","Recent pulmonary embolism (within 3 months)","Pulmonary arteriovenous malformation","Active lung infection (pneumonia, empyema, or lung abscess requiring therapy within 1 month)","Symptomatic heart failure (American College of Cardiology \\[ACC\\]\u002FAmerican Heart Association \\[AHA\\] stage C or D)","Left bundle branch block (contraindication to pulmonary angiography)","Renal failure (estimated glomerular filtration rate \\[eGFR\\] \\< 30 mL\u002Fmin\u002F1.73 m\\^2)","Pregnancy or intent to become pregnant","Breast feeding","Altered mental status that would interfere with consent or follow-up","Platelets \\< 50,000 (after transfusion, if needed)","International normalized ratio (INR) \\> 2 (after transfusion, if needed)","Hemoglobin \\< 7 (after transfusion, if needed)","Hyperthyroidism or history of hyperthyroidism, including subclinical hyperthyroidism (contraindication to lipiodol)","Planned radioactive iodine imaging or therapy (contraindication to lipiodol)","Allergy to lipiodol or mitomycin","Allergy to iodinated contrast that cannot be treated with steroid \u002F diphenhydramine premedication","Any condition that, in the opinion of the investigator, would interfere with evaluation of the investigational product, or that would affect subject safety","Inclusion Criteria:\n\n* Lung cancer or lung metastases, with lung, endobronchial, pleural, or mediastinal tumors that are progressing on systemic therapy (or the patient cannot tolerate systemic therapy), and that are not amenable to resection, thermal ablation, or ablative radiation therapy\n* Lung-dominant disease (majority of active tumor volume is in the chest)\n* At least 18 years old\n\nExclusion Criteria:\n\n* Eastern Cooperative Oncology Group (ECOG) performance status \\> 2\n* Oxygen saturation \\< 92% on room air\n* Forced expiratory volume in 1 second (FEV1) \\< 60%\n* No measurable treatable disease, per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (for example, unable to measure tumor size on CT, or lung nodules are all \\< 1 cm)\n* Life expectancy \\< 6 months\n* Pulmonary hypertension (diagnosed or suspected on echocardiography, CT, magnetic resonance imaging \\[MRI\\], or direct pressure measurement)\n* Recent pulmonary embolism (within 3 months)\n* Pulmonary arteriovenous malformation\n* Active lung infection (pneumonia, empyema, or lung abscess requiring therapy within 1 month)\n* Symptomatic heart failure (American College of Cardiology \\[ACC\\]\u002FAmerican Heart Association \\[AHA\\] stage C or D)\n* Left bundle branch block (contraindication to pulmonary angiography)\n* Renal failure (estimated glomerular filtration rate \\[eGFR\\] \\< 30 mL\u002Fmin\u002F1.73 m\\^2)\n* Pregnancy or intent to become pregnant\n* Breast feeding\n* Altered mental status that would interfere with consent or follow-up\n* Platelets \\< 50,000 (after transfusion, if needed)\n* International normalized ratio (INR) \\> 2 (after transfusion, if needed)\n* Hemoglobin \\< 7 (after transfusion, if needed)\n* Hyperthyroidism or history of hyperthyroidism, including subclinical hyperthyroidism (contraindication to lipiodol)\n* Planned radioactive iodine imaging or therapy (contraindication to lipiodol)\n* Allergy to lipiodol or mitomycin\n* Allergy to iodinated contrast that cannot be treated with steroid \u002F diphenhydramine premedication\n* Any condition that, in the opinion of the investigator, would interfere with evaluation of the investigational product, or that would affect subject safety",[158,159],"ADULT","OLDER_ADULT",[161,177],{"facility":12,"status":7,"city":162,"state":163,"zip":164,"country":165,"contacts":166,"geoPoint":174},"Duarte","California","91010","United States",[167,172],{"name":168,"role":169,"phone":170,"email":171},"Franz E. Boas","CONTACT","626-218-8708","fboas@coh.org",{"name":168,"role":173},"PRINCIPAL_INVESTIGATOR",{"lat":175,"lon":176},34.13945,-117.97729,{"facility":178,"status":7,"city":179,"state":179,"zip":180,"country":165,"contacts":181,"geoPoint":187},"Memorial Sloan Kettering Cancer Center","New York","10065",[182,186],{"name":183,"role":169,"phone":184,"email":185},"Stephen B. Solomon, MD","212-639-5012","solomons@mskcc.org",{"name":183,"role":173},{"lat":188,"lon":189},40.71427,-74.00597,[191],{"name":192,"role":169,"phone":170,"email":171},"Franz Edward Boas, MD",[194],{"name":195,"affiliation":12,"role":173},"Franz E Boas, MD",[197],{"pmid":198,"type":199,"citation":200},"37611799","DERIVED","Boas FE, Salgia R, Waddington T, Massarelli E, Park JJ, Kessler J, Frankel P, Alexander ES, Solomon SB. Phase II Trial of Lung Chemoembolization. J Vasc Interv Radiol. 2023 Dec;34(12):2090-2092. doi: 10.1016\u002Fj.jvir.2023.08.006. Epub 2023 Aug 21. No abstract available.",[],{"nct_id":4,"conditions":203,"biomarkers":208},[204,205,18,19,206,20,24,207],"Colon Carcinoma","Endobronchial Mass","Metastatic Malignant Neoplasm in the Lung","Solid Neoplasm",[],{"nct_id":4,"found":14,"summary":210,"prompt_version":220},{"design":211,"status":212,"heading":213,"summary":214,"follow_up":215,"word_count":216,"commitments":217,"compensation":218,"drugs_mentioned":219},"This is a Phase II interventional study, meaning all 30 participants will receive the same treatment. It is designed to evaluate the safety and effectiveness of lung chemoembolization.","completed","Phase II Lung Chemoembolization for Lung Cancer and Metastases","This Phase II study is testing a treatment called transarterial chemoembolization (TACE) for people with non-small cell lung cancer or lung metastases (cancer that has spread to the lungs). TACE involves injecting chemotherapy, specifically Mitomycin, along with Ethiodized Oil and Tris-acryl Gelatin Microspheres, directly into the blood vessels feeding the tumors in your lungs. This process aims to deliver a high dose of chemotherapy to the tumor while also cutting off its blood supply. The study is looking at how well this treatment controls the cancer in the treated area and any side effects you might experience. You may be able to join if you have lung cancer or lung metastases that are growing despite other treatments, or if you can't tolerate other treatments, and if your tumors can't be removed by surgery or other procedures. The study plans to enroll 30 participants, but its current status is unclear.","The study will track how long it takes for the cancer to progress in the treated area or for death to occur, up to 6 months. Adverse events will be monitored for up to 3 months after your last chemoembolization procedure.",149,"You will undergo the transarterial chemoembolization (TACE) procedure. Your response to treatment will be checked using Computed Tomography (CT) scans.","Not stated in the trial record.",[51,59,80,87],"v2"]