Study on Reducing Radiation and Chemotherapy in People with Head and Neck Cancer

Sponsor: Memorial Sloan Kettering Cancer Center

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT05544136

This clinical trial is exploring a new treatment approach that uses lower doses of radiation and chemotherapy, followed by planned surgery, to treat head and neck cancer. The study aims to see how effective this approach is in controlling the cancer.

Patient Parameters

Program Overview

The purpose of this study is to test if using less radiation and chemotherapy, followed by surgery, can effectively treat head and neck cancer. Researchers want to see if this approach can control the cancer while potentially reducing side effects from treatment.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with squamous cell carcinoma (SCC) of the head and neck, excluding certain areas like the nasopharynx and oral cavity.
  • Unknown primary SCC with visible lymph nodes is allowed if certain conditions are met.
  • If the cancer is in the oropharynx or unknown primary, a specific test (P16 IHC) must be negative.
  • If the cancer is in the hypopharynx or larynx, any P16 status is acceptable.
  • Cancer stage T0-3 N1-2C M0 without distant spread, based on specific scans.
  • 18 years or older.
  • No previous radiation or chemotherapy for head and neck cancer.
  • Patients who had surgery to remove the primary tumor but still have enlarged lymph nodes are eligible.
  • Good overall health with a performance status score of 70 or higher.
  • Recent CT or MRI scan of the neck.
  • Adequate blood cell counts and organ function based on recent tests.
  • Negative pregnancy test for women of childbearing potential.
  • Must provide informed consent to participate.

Exclusion Criteria

  • Cancer in certain areas like the nasopharynx or oral cavity.
  • Advanced cancer stage T4 or N3.
  • Previous radiation or chemotherapy for head and neck cancer.
  • Previous chemotherapy or radiation within the last three years.
  • Previous surgery for the same cancer, except for certain conditions.
  • Other invasive cancers unless disease-free for three years or high cure rate.
  • Pregnant or breastfeeding women.
  • Severe health conditions like recent heart attack or severe infections.

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