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Recruiting NCT05672108

Phase II Trial of Lung Chemoemobolization

Phase II Interventional Lung Non-Small Cell Carcinoma Mediastinal Neoplasm Pleural Neoplasm Lung Metastases From Any Primary

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Computed Tomography, Ethiodized Oil, Mitomycin, Transarterial Chemoembolization.
Who it may be relevant to
Registry conditions: Lung Non-Small Cell Carcinoma, Mediastinal Neoplasm, Pleural Neoplasm, Lung Metastases From Any Primary. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Procedure Computed Tomography
    Undergo CT
  • Drug Ethiodized Oil
    Given IA
  • Drug Mitomycin
    Given IA
  • Procedure Transarterial Chemoembolization
    Undergo TACE
  • Device Tris-acryl Gelatin Microspheres
    Given IA

Primary outcome measures

  • 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]
  • Incidence of adverse events [Time frame: Up to 3 months after the last chemoembolization procedure]
Secondary outcome measures (6)
  • 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

Inclusion criteria

  • Lung cancer or lung metastases, 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 2 centers
  • City of Hope Medical Center — Duarte
  • Memorial Sloan Kettering Cancer Center — New York

Publications

  • 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. PMID 37611799

Identifiers

NCT: NCT05672108 · 22067 · P30CA033572 · NCI-2022-10436 · 22067

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗