Study on Chemo-Embolization for Head and Neck Cancer
Sponsor: University of Alabama at Birmingham
ClinicalTrials ID:NCT04595981
This clinical trial is testing whether adding a treatment called chemo-embolization to the usual care of radiation and chemotherapy or immunotherapy can help improve outcomes for patients with head and neck cancer who cannot take the drug cisplatin.
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Program Overview
The purpose of this study is to find out if a treatment called chemo-embolization can help patients with head and neck cancer live longer without the disease getting worse. This treatment will be added to the standard care of radiation and chemotherapy or immunotherapy. The study will involve 48 patients who cannot take the drug cisplatin due to certain health conditions. Researchers will check the progress of the cancer at 3, 6, and 24 months after the treatment using imaging tests like CT or MRI scans. They will also track the overall survival of the patients to see if this new approach is more effective than past treatments.
Description
This study is a Phase II trial, meaning it is in the early stages of testing a new treatment approach. It will take place at a single location and involve 48 patients over two years. The goal is to see if adding chemo-embolization to the usual treatment of radiation and chemotherapy or immunotherapy can help patients with head and neck cancer live longer without the cancer progressing. Chemo-embolization is a procedure that delivers chemotherapy directly to the tumor while blocking its blood supply. This study is specifically for patients who cannot take the drug cisplatin due to certain health issues. Researchers will monitor the patients' cancer status at 3, 6, and 24 months after treatment using imaging tests. They will also keep track of the patients' overall survival to compare with past outcomes in similar patients.
Eligibility Criteria
Inclusion Criteria
- Must provide signed and dated consent to participate.
- Willing to follow all study procedures and be available for the study duration.
- Must be 18 years or older.
- Diagnosed with squamous cell carcinoma of the head and neck.
- Able to undergo chemo-embolization.
- Women of childbearing potential must have a negative pregnancy test before the procedure.
- Cannot take cisplatin due to certain health conditions like kidney, nerve, or ear problems, or have a performance status of 2 or higher.
- Plan to receive standard radiation and chemotherapy or immunotherapy.
Exclusion Criteria
- Not medically fit for chemo-embolization.
- Participating in another trial that does not allow additional chemo-embolization treatment.
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