Phase II Trial of Lung Chemoemobolization

Обзор

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.

Подробное описание

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.

Вмешательства

• Процедура Computed Tomography
  Undergo CT
• Препарат Ethiodized Oil
  Given IA
• Препарат Mitomycin
  Given IA
• Процедура Transarterial Chemoembolization
  Undergo TACE
• Устройство Tris-acryl Gelatin Microspheres
  Given IA

Первичные конечные точки

• Local progression free survival [Срок оценки: 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 [Срок оценки: Up to 3 months after the last chemoembolization procedure]

Вторичные конечные точки (6)

• Objective response rate (best response) [Срок оценки: Within 3 months of treatment]
• Overall survival [Срок оценки: Up to 9 months]
• Progression-free survival [Срок оценки: Up to 9 months]
• Bronchial versus pulmonary artery blood supply [Срок оценки: Up to 9 months]
• Lipiodol retention in treated tumors [Срок оценки: 4-6 weeks post-procedure]
• Growth of TACE targeted lesions versus non-TACE targeted lesions [Срок оценки: 4-6 weeks post-procedure]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 2 центра

• City of Hope Medical Center — Duarte
• Memorial Sloan Kettering Cancer Center — New York

Публикации

• 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

Идентификаторы

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

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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