Transarterial Chemoembolization for the Treatment of Lung Cancer

Lung Non-Small Cell Carcinoma Clinical Trial

Official title:

Phase II Trial of Lung Chemoembolization

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05672108
• Other study ID #: 22067
• Secondary ID: NCI-2022-1043622
• Status: Recruiting
• Phase: Phase 2
• Start date: May 12, 2023
• Est. completion date: October 31, 2024

Study information

• Verified date: June 2023
• Source: City of Hope Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This phase II trial evaluates how well transarterial chemoembolization (TACE) works for treating patients with non-small cell lung cancer. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: October 31, 2024
• Est. primary completion date: October 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Non-Small Cell Carcinoma
• Mediastinal Neoplasms
• Neoplasms
• Pleural Neoplasm
• Pleural Neoplasms

Intervention

Procedure:
• Computed Tomography
Undergo CT

Drug:
• Ethiodized Oil
Given IA
• Mitomycin
Given IA

Procedure:
• Transarterial Chemoembolization
Undergo TACE

Device:
• Tris-acryl Gelatin Microspheres
Given IA

Locations

Country	Name	City	State
United States	City of Hope Medical Center	Duarte	California

Sponsors (2)

Lead Sponsor	Collaborator
City of Hope Medical Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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 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
Primary	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
Secondary	Objective response rate (best response)	Evaluated on a per-treatment basis, using RECIST version 1.1 criteria.	Within 3 months of treatment
Secondary	Overall survival	Will be estimated using the Kaplan-Meier method.	Up to 9 months
Secondary	Progression-free survival	Will be estimated using the Kaplan-Meier method.	Up to 9 months
Secondary	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.	Up to 9 months
Secondary	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
Secondary	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.	4-6 weeks post-procedure