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.
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
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)
Single group
Computed Tomography
Procedure/SurgeryUndergo CT
Ethiodized Oil
DrugGiven IA
Mitomycin
DrugGiven IA
Transarterial Chemoembolization
Procedure/SurgeryUndergo TACE
Tris-acryl Gelatin Microspheres
DeviceGiven IA
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.
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.
Objective response rate (best response)
Evaluated on a per-treatment basis, using RECIST version 1.1 criteria.
Overall survival
Will be estimated using the Kaplan-Meier method.
Progression-free survival
Will be estimated using the Kaplan-Meier method.
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.
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City of Hope Medical Center
Lead sponsor
National Cancer Institute (NCI)
Collaborator
