A Phase 2 interventional study of Computed Tomography and Ethiodized Oil in Lung Non-Small Cell Carcinoma, Mediastinal Neoplasm and Pleural Neoplasm, sponsored by City of Hope Medical Center. Recruiting at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-05.
Sponsored by City of Hope Medical Center · Phase 2, Interventional, and Treatment
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:
I. To determine safety and efficacy (local progression free survival) of chemoembolization of lung cancer that is chemorefractory, unresectable, and unablatable.
OUTLINE:
Patients receive lung chemoembolization using Lipiodol, mitomycin, and Embospheres. Response to treatment is evaluated on computed tomography (CT) scans.
Exclusion Criteria:
Patients receive lipiodol intra-arterially (IA), mitomycin IA, and embospheres IA and undergo TACE on study. Patients also undergo angiography and computed tomography (CT) at baseline and follow up.
Procedure: Computed Tomography · Drug: Ethiodized Oil · Drug: Mitomycin · Procedure: Transarterial Chemoembolization · Device: Tris-acryl Gelatin Microspheres
Undergo CT
Also known as: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized Tomography, CT, CT Scan, tomography
Given IA
Also known as: Ethiodol, Iodized Oil, Lipiodol
Given IA
Also known as: 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
Undergo TACE
Also known as: TACE
Given IA
Also known as: Embospheres, TAGM, Trisacryl Gelatin Microspheres
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 frame: 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
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.
Time frame: Up to 3 months after the last chemoembolization procedure
Objective response rate (best response)
Evaluated on a per-treatment basis, using RECIST version 1.1 criteria.
Time frame: Within 3 months of treatment
Overall survival
Will be estimated using the Kaplan-Meier method.
Time frame: Up to 9 months
Progression-free survival
Will be estimated using the Kaplan-Meier method.
Time frame: Up to 9 months
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.
Time frame: Up to 9 months
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.
Time frame: 4-6 weeks post-procedure
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.
Time frame: 4-6 weeks post-procedure
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Carcinoma, Non-Small-Cell Lung→
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