Back to resultsTransarterial Chemoembolization for the Treatment of Lung Cancer
Primary Purpose
Lung Non-Small Cell Carcinoma, Mediastinal Neoplasm, Pleural Neoplasm
Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Computed Tomography
Ethiodized Oil
Mitomycin
Transarterial Chemoembolization
Tris-acryl Gelatin Microspheres
Sponsored by
About this trial
This is an interventional treatment trial for Lung Non-Small Cell Carcinoma
Eligibility 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
Sites / Locations
- City of Hope Medical CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Lung chemoembolization
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
Full Information
NCT ID
NCT05672108
First Posted
January 3, 2023
Last Updated
June 26, 2023
Sponsor
City of Hope Medical Center
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT05672108
Brief Title
Transarterial Chemoembolization for the Treatment of Lung Cancer
Official Title
Phase II Trial of Lung Chemoembolization
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 12, 2023 (Actual)
Primary Completion Date
October 31, 2024 (Anticipated)
Study Completion Date
October 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
City of Hope Medical Center
Collaborators
National Cancer Institute (NCI)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Non-Small Cell Carcinoma, Mediastinal Neoplasm, Pleural Neoplasm
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Lung chemoembolization
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Computed Tomography
Other Intervention Name(s)
CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized Tomography, CT, CT Scan, tomography
Intervention Description
Undergo CT
Intervention Type
Drug
Intervention Name(s)
Ethiodized Oil
Other Intervention Name(s)
Ethiodol, Iodized Oil, Lipiodol
Intervention Description
Given IA
Intervention Type
Drug
Intervention Name(s)
Mitomycin
Other Intervention Name(s)
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
Intervention Description
Given IA
Intervention Type
Procedure
Intervention Name(s)
Transarterial Chemoembolization
Other Intervention Name(s)
TACE
Intervention Description
Undergo TACE
Intervention Type
Device
Intervention Name(s)
Tris-acryl Gelatin Microspheres
Other Intervention Name(s)
Embospheres, TAGM, Trisacryl Gelatin Microspheres
Intervention Description
Given IA
Primary Outcome Measure Information:
Title
Local progression free survival
Description
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
Title
Incidence of adverse events
Description
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 Outcome Measure Information:
Title
Objective response rate (best response)
Description
Evaluated on a per-treatment basis, using RECIST version 1.1 criteria.
Time Frame
Within 3 months of treatment
Title
Overall survival
Description
Will be estimated using the Kaplan-Meier method.
Time Frame
Up to 9 months
Title
Progression-free survival
Description
Will be estimated using the Kaplan-Meier method.
Time Frame
Up to 9 months
Title
Bronchial versus pulmonary artery blood supply
Description
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
Title
Lipiodol retention in treated tumors
Description
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
Title
Growth of TACE targeted lesions versus non-TACE targeted lesions
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Franz E Boas
Organizational Affiliation
City of Hope Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
City of Hope Medical Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Franz E. Boas
Phone
626-218-8708
Email
fboas@coh.org
First Name & Middle Initial & Last Name & Degree
Franz E. Boas
12. IPD Sharing Statement
Learn more about this trial
Transarterial Chemoembolization for the Treatment of Lung Cancer
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