RECRUITING

Transarterial Chemoembolization for the Treatment of Lung Cancer and Lung Metastases

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Transarterial Chemoembolization for the Treatment of Lung Cancer and Lung Metastases

Quick Facts

Study Start:2023-05-12
Study Completion:2026-10-28
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05672108

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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
  2. * Lung-dominant disease (majority of active tumor volume is in the chest)
  3. * At least 18 years old
  1. * Eastern Cooperative Oncology Group (ECOG) performance status \> 2
  2. * Oxygen saturation \< 92% on room air
  3. * Forced expiratory volume in 1 second (FEV1) \< 60%
  4. * 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)
  5. * Life expectancy \< 6 months
  6. * Pulmonary hypertension (diagnosed or suspected on echocardiography, CT, magnetic resonance imaging \[MRI\], or direct pressure measurement)
  7. * Recent pulmonary embolism (within 3 months)
  8. * Pulmonary arteriovenous malformation
  9. * Active lung infection (pneumonia, empyema, or lung abscess requiring therapy within 1 month)
  10. * Symptomatic heart failure (American College of Cardiology \[ACC\]/American Heart Association \[AHA\] stage C or D)
  11. * Left bundle branch block (contraindication to pulmonary angiography)
  12. * Renal failure (estimated glomerular filtration rate \[eGFR\] \< 30 mL/min/1.73 m\^2)
  13. * Pregnancy or intent to become pregnant
  14. * Breast feeding
  15. * Altered mental status that would interfere with consent or follow-up
  16. * Platelets \< 50,000 (after transfusion, if needed)
  17. * International normalized ratio (INR) \> 2 (after transfusion, if needed)
  18. * Hemoglobin \< 7 (after transfusion, if needed)
  19. * Hyperthyroidism or history of hyperthyroidism, including subclinical hyperthyroidism (contraindication to lipiodol)
  20. * Planned radioactive iodine imaging or therapy (contraindication to lipiodol)
  21. * Allergy to lipiodol or mitomycin
  22. * Allergy to iodinated contrast that cannot be treated with steroid / diphenhydramine premedication
  23. * Any condition that, in the opinion of the investigator, would interfere with evaluation of the investigational product, or that would affect subject safety

Contacts and Locations

Study Contact

Franz Edward Boas, MD
CONTACT
626-218-8708
fboas@coh.org

Principal Investigator

Franz E Boas, MD
PRINCIPAL_INVESTIGATOR
City of Hope Medical Center

Study Locations (Sites)

City of Hope Medical Center
Duarte, California, 91010
United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
United States

Collaborators and Investigators

Sponsor: City of Hope Medical Center

  • Franz E Boas, MD, PRINCIPAL_INVESTIGATOR, City of Hope Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-05-12
Study Completion Date2026-10-28

Study Record Updates

Study Start Date2023-05-12
Study Completion Date2026-10-28

Terms related to this study

Additional Relevant MeSH Terms

  • Lung Non-Small Cell Carcinoma
  • Mediastinal Neoplasm
  • Pleural Neoplasm
  • Lung Metastases From Any Primary
  • Endobronchial Metastases
  • Colon Cancer
  • Sarcoma