Transarterial Chemoembolization for the Treatment of Lung Cancer
Study Details
Study Description
Brief Summary
This phase II trial evaluates how well transarterial chemoembolization (TACE) works in treating patients with non-small cell lung cancer. TACE involves the injection of a blocking agent (tris-acryl gelatin microspheres [embospheres]) and a chemotherapy agent (mitomycin) directly into the artery that supplies oxygen to lung tumors. Mitomycin works by inhibiting deoxyribonucleic acid synthesis. At the same time, the artery is blocked (embolized) with a blocking agent called tris-acryl gelatin microspheres (embospheres). 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. An imaging agent called ethiodized oil (lipiodol) is also used during the procedure for help visualizing the tumor. TACE with mitomycin, lipiodol, and embospheres may be effective at controlling or stopping the growth of lung tumors.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed Description
PRIMARY OBJECTIVE:
- To determine safety and efficacy (local progression free survival) of chemoembolization of lung cancer that is chemorefractory, unresectable, and unablatable.
OUTLINE:
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Treatment (TACE, mitomycin, ethiodized oil, embospheres) Patients receive lipiodol IA, mitomycin IA, and embospheres IA and undergo TACE on study. Patients also undergo angiography and CT at baseline and follow up. |
Procedure: Angiography
Undergo angiography
Procedure: Computed Tomography
Undergo CT
Other Names:
Drug: Ethiodized Oil
Given IA
Other Names:
Drug: Mitomycin
Given IA
Other Names:
Procedure: Transarterial Chemoembolization
Undergo TACE
Other Names:
Drug: Tris-acryl Gelatin Microspheres
Given IA
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Local progression free survival [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]
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 [Up to 3 months after the last chemoembolization procedure]
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.
- Change in oxygen saturation [Pre and post procedure, assessed up to 9 months]
Will be evaluated using the Wilcoxon signed-rank test.
- Change in forced vital capacity [Pre and post procedure, assessed up to 9 months]
Will be evaluated using the Wilcoxon signed-rank test.
- Change in forced expiratory volume in 1 second [Pre and post procedure, assessed up to 9 months]
Will be evaluated using the Wilcoxon signed-rank test.
Secondary Outcome Measures
- Objective response rate (best response) [Within 3 months of treatment]
Evaluated on a per-treatment basis, using RECIST version 1.1 criteria.
- Overall survival [Up to 9 months]
Will be estimated using the Kaplan-Meier method.
- Progression-free survival [Up to 9 months]
Will be estimated using the Kaplan-Meier method.
- Bronchial versus pulmonary artery blood supply [Up to 9 months]
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.
- Lipiodol retention in treated tumors [4-6 weeks post-procedure]
Correlation between lipiodol retention and change in tumor size will be evaluated using Spearman's rank correlation coefficient (rho) and Spearman's test.
- Growth of TACE targeted lesions versus non-TACE targeted lesions [4-6 weeks post-procedure]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Non-small cell lung cancer (any stage), 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
Exclusion Criteria:
-
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]/American Heart Association [AHA] stage C or D)
-
Left bundle branch block (contraindication to pulmonary angiography)
-
Renal failure (estimated glomerular filtration rate [eGFR] < 30 mL/min/1.73 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 / 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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | City of Hope Medical Center | Duarte | California | United States | 91010 |
Sponsors and Collaborators
- City of Hope Medical Center
- National Cancer Institute (NCI)
Investigators
- Principal Investigator: Franz E Boas, City of Hope Medical Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 22067
- NCI-2022-10436
- 22067
- P30CA033572