Phase II Trial of Lung Chemoemobolization
Summary
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.
Detailed description
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.
Arms & interventions
- ProcedureComputed Tomography
Undergo CT
- DrugEthiodized Oil
Given IA
- DrugMitomycin
Given IA
- ProcedureTransarterial Chemoembolization
Undergo TACE
- DeviceTris-acryl Gelatin Microspheres
Given IA
Outcome measures
Primary
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
Secondary
Objective response rate (best response)
Time frame: Within 3 months of treatment
Overall survival
Time frame: Up to 9 months
Progression-free survival
Time frame: Up to 9 months
Bronchial versus pulmonary artery blood supply
Time frame: Up to 9 months
Lipiodol retention in treated tumors
Time frame: 4-6 weeks post-procedure
Growth of TACE targeted lesions versus non-TACE targeted lesions
Time frame: 4-6 weeks post-procedure
Eligibility criteria
Study locations (2)
City of Hope Medical Center
Duarte, California, 91010
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
References
- 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/j.jvir.2023.08.006. Epub 2023 Aug 21. No abstract available.(PubMed)