Pilot Study of Personalized Induction Therapy and Adaptive Treatment Using Circulating Tumor DNA in Adults with Locally Advanced HPV-Negative Head and Neck Squamous Cell Carcinoma

What this Trial Is About

Researchers are evaluating whether blood-based biomarker testing can help personalize cancer treatment for patients with locally advanced head and neck squamous cell carcinoma that is HPV-negative. This phase 1 trial focuses on patients with stage III or IV disease in areas like the oral cavity, oropharynx, hypopharynx, nasopharynx, larynx, or sinuses. The study aims to determine if circulating tumor DNA levels can predict response to treatment. All participants first receive three cycles of chemotherapy over nine weeks using paclitaxel, carboplatin, and cetuximab. After this induction chemotherapy, imaging is used to assess disease response. Those with a significant response receive low dose radiation plus chemotherapy CRT for 6.5 weeks, while those with limited response receive standard dose radiation plus chemotherapy for 7 weeks. The investigator selects the chemotherapy drugs given during CRT, which may include cisplatin or a regimen with paclitaxel, fluorouracil, and hydroxyurea. Throughout the study, participants undergo imaging to measure disease response and provide blood samples to measure biomarkers including circulating tumor DNA. Researchers track side effects related to treatment and evaluate long-term disease response up to two years after treatment. The main outcome measures include treatment completion rates and predictive value of tumor DNA at nine weeks. Safety and disease status are monitored regularly during and after therapy, with total involvement lasting up to two years.

Personalized, Adaptive Treatment for Locally Advanced Head and Neck Cancer