Clinical Trials

The trial that should settle sentinel lymph node biopsy versus elective neck dissection in early-stage oral cavity cancer. The phase II portion completed accrual in December 2024 with 261 patients, met its criteria, and the trial re-opened to phase III in November 2025, seeking 425 additional patients for a total of 686.

Co-primary endpoints: superior patient-reported neck and shoulder function at six months with SLNB, and non-inferior disease-free survival. Dr. Stephen Lai, one of the driving investigators, is a Penn residency graduate.

NBTXR3 is a first-in-class hafnium oxide nanoparticle injected directly into the tumor. It is inert on its own and amplifies the local dose deposited by radiation without increasing dose to surrounding tissue.

A global randomized phase III of NBTXR3 plus RT ± cetuximab versus RT ± cetuximab in 500 patients aged 60 and older who cannot take platinum. The protocol was amended in 2026 to drop the interim analysis and read out on fewer events, so results should land sooner.

The newer phase I of the same agent as NANORAY-312, now called JNJ-90301900, given intratumorally and intranodally alongside concurrent cisplatin chemoradiation. Opened in January 2026.

Worth reading as a case study in what a trial demands from a multidisciplinary team: someone injects the nanoparticle under image guidance, someone maps it to the radiation plan, someone manages the cisplatin, and someone consents, enrolls and follows the patient.