Journal Article

Prediction of residual disease using circulating DNA detection after potentiated radiotherapy for locally advanced head and neck cancer (NeckTAR): a study protocol for a prospective, multicentre trial

Bouvet, Clément, Saroul, Nicolas, Pham-Dang, Nathalie, Durando, Xavier, Ferreira, Marie-Céleste, Bernadach, Maureen, Molnar, Ioana, Biau, Julian, Ginzac, Angeline, Cayre, Anne

2023

Overview

Background Sensitive and reproducible detection of residual disease after treatment is a major challenge for patients with locally advanced head and neck cancer. Indeed, the current imaging techniques are not always reliable enough to determine the presence of residual disease. The aim of the NeckTAR trial is to assess the ability of circulating DNA (cDNA), both tumoral and viral, at three months post-treatment, to predict residual disease, at the time of the neck dissection, among patients with partial cervical lymph node response on PET-CT, after potentiated radiotherapy. Methods This will be an interventional, multicentre, single-arm, open-label, prospective study. A blood sample will be screened for cDNA before potentiated radiotherapy and after 3 months if adenomegaly persists on the CT scan 3 months after the end of treatment. Patients will be enrolled in 4 sites in France. Evaluable patients, i.e. those with presence of cDNA at inclusion, an indication for neck dissection, and a blood sample at M3, will be followed for 30 months. Thirty-two evaluable patients are expected to be recruited in the study. Discussion The decision to perform neck dissection in case of persistent cervical adenopathy after radio-chemotherapy for locally advanced head and neck cancer is not always straightforward. Although studies have shown that circulating tumour DNA is detectable in a large proportion of patients with head and neck cancer, enabling the monitoring of response, the current data is insufficient to allow routine use of this marker. Our study could lead to better identification of patients who do not have residual lymph node disease in order to avoid neck dissection and preserve their quality-of-life while maintaining their prospects of survival. Trial registration Clinicaltrials.gov: NCT05710679, registered on 02/02/2023, https://clinicaltrials.gov/ct2/show/ . Identifier with the French National Agency for the Safety of Medicines and Health Products (ANSM): N°ID RCB 2022-A01668-35, registered on July 15 th , 2022.

• Publisher: BioMed Central,BioMed Central Ltd,BMC
• Subject: Analysis / Biomedical and Life Sciences / Biomedicine / Cancer / Cancer Research / Carcinoma, Squamous Cell - pathology / Care and treatment / Cell-Free Nucleic Acids / Chemotherapy / Circulating DNA / Complications and side effects / CT imaging / Diagnosis / Diagnostic imaging / DNA / DNA, Complementary / Genetic aspects / Genetic research / Head and neck cancer / Head and Neck Neoplasms - genetics / Head and Neck Neoplasms - radiotherapy / Health Promotion and Disease Prevention / HPV-HR / Humans / Life Sciences / Lymphatic diseases / Medicine/Public Health / Multicenter Studies as Topic / Oncology / Oncology, Experimental / Papillomavirus infections / Patient outcomes / Positron Emission Tomography Computed Tomography / Potentiated radiotherapy / Prospective Studies / Radical neck dissection / Radiotherapy / Residual disease / Risk factors / Study Protocol / Surgical Oncology