Prediction of Residual Disease by Circulating DNA Detection After Potentiated Radiotherapy for Locally Advanced Head and Neck Cancer

What this Trial Is About

Locally advanced head and neck squamous cell carcinomas (HNSCCs) often have high rates of locoregional failure after treatment. Detecting remaining disease after therapy is challenging because current imaging methods like PET-CT can give false positives due to inflammation. Researchers are studying whether circulating tumor DNA (ctDNA) in blood can provide a more reliable way to assess treatment response and detect residual disease in these patients. This is a multicenter, open-label study focusing on patients with locally advanced head and neck cancer receiving potentiated radiotherapy. Participants will have blood samples taken twice: first before starting treatment and again three months after radiochemotherapy if PET-CT shows an incomplete response. The study will monitor circulating DNA levels to see how well they correspond to residual lymph node disease detected by PET-CT. The intervention involves biological sampling, and no placebo or comparison group is used since it is a single-arm study. The study also includes assessments of tumor genomics and HPV status. During the study, patients will undergo PET-CT scans and blood tests at specified times to monitor residual disease. Researchers will evaluate the rate of incomplete lymph node response, the presence of circulating DNA, and the match between tumor and blood DNA profiles. The study will collect data over an average of 66 months, including long-term clinical and pathological features. Outcomes include the accuracy of ctDNA detection, prognostic value, and interobserver consistency in PET-CT interpretation. Participants are monitored for disease status and treatment response throughout the follow-up period.

Prediction of Residual Disease by Circulating DNA Detection After Potentiated Radiotherapy for Locally Advanced Head and Neck Cancer