Comparing Two Common Treatments to Determine a Standard of Care for Patients with Locoregionally Advanced Head and Neck Cancer and a Contraindication to Cisplatin (NRG-HN016, The CONCISE Trial)

07/15/2026

Last month, NRG Oncology activated the NRG-HN016 trial, also known as the “CONCISE” trial, for patients with locoregionally advanced head and neck cancer with a contraindication to cisplatin. This pragmatic phase III randomized study will be comparing radiotherapy (RT) and carboplatin/paclitaxel to RT and cetuximab treatments to determine which regimen improves outcomes for these patients.

“CONCISE is the first study comparing the two most commonly used regimens for this population. In addition to cetuximab and carboplatin/paclitaxel, several alternatives, including carboplatin, docetaxel, and immune checkpoint inhibitors, have been studied as substitutes for cisplatin, yet no regimen has been established as standard. Therefore, the CONCISE trial will aim to establish a standard of care for this population,” stated Loren K. Mell, MD, of the University of California in San Diego and the Principal Investigator of the CONCISE trial.

The CONCISE study aims to enroll 454 patients with either stage III-IVB p16-negative or stage II-III p16-postive squamous cell carcinoma of the oropharynx, larynx, hypopharynx, or oral cavity (medically operable) with a contraindication to cisplatin. Following stratification, patients will be randomized 1:1 to receive either the treatment arm receiving RT with concurrent cetuximab or the treatment arm receiving RT with concurrent carboplatin/paclitaxel.

The primary objective of this study is to determine which treatment is better at improving progression-free survival (PFS) outcomes for patients in this trial. Secondary objectives including comparing overall survival (OS), safety and toxicity, patterns of failure, and changes in diet, eating, and speech behaviors between treatment arms. Additionally, PFS and OS rates will be compared by study arm within p16-negative and p16-postiive patient subgroups.

More information:

More on NRG-HN016 can be found at ClinicalTrials.gov

Protocol documents for NRG-HN016 are available on CTSU.org.

This study has a patient study webpage available at www.NRGOncology.org/CONCISE