Transarterial Chemoembolization for the Treatment of Lung Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT05672108|
Recruitment Status : Not yet recruiting
First Posted : January 5, 2023
Last Update Posted : January 5, 2023
|Condition or disease||Intervention/treatment||Phase|
|Lung Non-Small Cell Carcinoma Mediastinal Neoplasm Pleural Neoplasm||Procedure: Angiography Procedure: Computed Tomography Drug: Ethiodized Oil Drug: Mitomycin Procedure: Transarterial Chemoembolization Drug: Tris-acryl Gelatin Microspheres||Phase 2|
I. To determine safety and efficacy (local progression free survival) of chemoembolization of lung cancer that is chemorefractory, unresectable, and unablatable.
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Trial of Lung Chemoembolization|
|Estimated Study Start Date :||May 24, 2023|
|Estimated Primary Completion Date :||October 31, 2024|
|Estimated Study Completion Date :||October 31, 2024|
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: Computed Tomography
Drug: Ethiodized Oil
Procedure: Transarterial Chemoembolization
Other Name: TACE
Drug: Tris-acryl Gelatin Microspheres
- Local progression free survival [ 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 ]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 [ Time Frame: 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 [ Time Frame: Pre and post procedure, assessed up to 9 months ]Will be evaluated using the Wilcoxon signed-rank test.
- Change in forced vital capacity [ Time Frame: 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 [ Time Frame: Pre and post procedure, assessed up to 9 months ]Will be evaluated using the Wilcoxon signed-rank test.
- Objective response rate (best response) [ Time Frame: Within 3 months of treatment ]Evaluated on a per-treatment basis, using RECIST version 1.1 criteria.
- Overall survival [ Time Frame: Up to 9 months ]Will be estimated using the Kaplan-Meier method.
- Progression-free survival [ Time Frame: Up to 9 months ]Will be estimated using the Kaplan-Meier method.
- Bronchial versus pulmonary artery blood supply [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05672108
|United States, California|
|City of Hope Medical Center|
|Duarte, California, United States, 91010|
|Contact: Franz E. Boas 626-218-8708 firstname.lastname@example.org|
|Principal Investigator: Franz E. Boas|
|Principal Investigator:||Franz E Boas||City of Hope Medical Center|