Reduced Radiation and Chemotherapy Followed by Planned Neck Dissection Surgery for Head and Neck Cancer Patients Without Tumor Hypoxia

What this Trial Is About

Researchers are evaluating a treatment approach involving reduced radiation and chemotherapy followed by planned neck dissection surgery for people with head and neck cancer. This Phase 2 study focuses on patients with certain types of squamous cell carcinoma in the head and neck region who test negative for tumor hypoxia using a special PETCT scan. The purpose is to assess how effective this de-escalated treatment is against participants cancer. Participants who test negative for hypoxia on the 18F-FMISO PETCT scan will receive chemoradiation therapy with lower radiation doses to the primary tumor and lymph nodes, combined with two cycles of standard chemotherapy drugs such as cisplatin or carboplatin5-Fluorouracil. Those who test positive for hypoxia will be removed from the study and receive standard care chemoradiation with higher radiation doses. The treatment plan includes imaging and potential dosage adjustments based on pilot efficacy data. During the study, participants will undergo PETCT imaging to determine hypoxia status shortly after radiation therapy begins. They will be monitored for treatment response and side effects, with follow-up to assess survival rates over 2.5 years after chemoradiation therapy. Various scans, laboratory tests, and performance status evaluations will be conducted before and during treatment to ensure safety and track outcomes. The total study duration extends until March 2027.

A Study of Decreasing Radiation Therapy and Chemotherapy in People With Head and Neck Cancer