A Study to Assess Decreasing Radiation Therapy and Chemotherapy in People with Head and Neck Cancer

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Full Title

A Pilot Study of Radiation De-Escalation for p16 Negative Oropharyngeal Cancer and p16-Negative or Positive Laryngeal and Hypopharyngeal Cancers

Purpose

The standard treatment for head and neck cancers includes high-dose radiation therapy and chemotherapy, but it commonly causes side effects. In this study, researchers are assessing a treatment for head and neck cancer that starts with standard high-dose radiation therapy and chemotherapy and then reduces the doses of both treatments. Patients then have surgery to remove lymph nodes and tissue from the neck area.

It is believed that this “de-escalated” approach could be just as effective as the standard therapy, but with fewer side effects. The chemotherapy drugs used in this study include cisplatin or carboplatin plus 5-fluorouracil and are given intravenously (by vein).

Who Can Join

To be eligible for this study, patients must meet several requirements, including:

  • Participants must have squamous cell carcinoma of the head and neck (oropharyngeal, laryngeal, or hypopharyngeal cancer) that has not metastasized.
  • Patients may not have previously received radiation therapy or chemotherapy for their head and neck cancer.
  • Patients must be physically well enough that they are able to be mobile, take care of themselves, and engage in all but physically strenuous activities. For example, they must be well enough that they could carry out office work or light housework.
  • This study is for people age 18 and older.

Contact

For more information and to ask about eligibility for this study, please contact the office of Dr. Kaveh Zakeri at 848-225-6435.

Protocol

22-227

Phase

Phase II (phase 2)

Disease Status

Newly Diagnosed

Investigator

ClinicalTrials.gov ID

NCT05544136