Phase II Lung Chemoembolization for Lung Cancer and Metastases
This Phase II study is testing a treatment called transarterial chemoembolization (TACE) for people with non-small cell lung cancer or lung metastases (cancer that has spread to the lungs). TACE involves injecting chemotherapy, specifically Mitomycin, along with Ethiodized Oil and Tris-acryl Gelatin Microspheres, directly into the blood vessels feeding the tumors in your lungs. This process aims to deliver a high dose of chemotherapy to the tumor while also cutting off its blood supply. The study is looking at how well this treatment controls the cancer in the treated area and any side effects you might experience. You may be able to join if you have lung cancer or lung metastases that are growing despite other treatments, or if you can't tolerate other treatments, and if your tumors can't be removed by surgery or other procedures. The study plans to enroll 30 participants, but its current status is unclear.
- Study design
- This is a Phase II interventional study, meaning all 30 participants will receive the same treatment. It is designed to evaluate the safety and effectiveness of lung chemoembolization.
- What's involved
- You will undergo the transarterial chemoembolization (TACE) procedure. Your response to treatment will be checked using Computed Tomography (CT) scans.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study will track how long it takes for the cancer to progress in the treated area or for death to occur, up to 6 months. Adverse events will be monitored for up to 3 months after your last chemoembolization procedure.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Phase II Trial of Lung Chemoemobolization
At a glance
Conditions
Where it's being run
2 sites across 2 statesStudy leadership
- Franz E Boas, MD · PRINCIPAL_INVESTIGATOR · City of Hope Medical Center
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Local progression free survivalTime 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 eventsUp 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.