DART 2.0 clinical trial seeks to advance precision medicine for HPV-driven head and neck cancers

Nov. 26, 2024

Mayo Clinic researchers are collaborating on a phase 2, multisite, interventional trial to evaluate a blood-based biomarker using a testing device for HPV-driven head and neck cancers.

HPV-related head and neck cancer is one of the fastest growing cancers in the U.S. This research has the potential to improve clinical outcomes by enabling physicians to select individualized treatment options that aim to decrease cancer recurrence and minimize the side effects and morbidity of treatment.

Collaborators from each of the three participating sites ― Mayo Clinic campuses in Florida, Arizona, and Minnesota ― launched the trial in February 2023 and plan to continue active enrollment through August 2028. Radiation oncologist Adam L. Holtzman, M.D., the Florida-site principal investigator, and otolaryngologists Jeffrey R. Janus, M.D., Phillip Pirgousis, M.D., and Samip Patel, M.D., also from the Florida site, are collaborating on research efforts.

DART 2.0 builds on the results of a previously reported de-escalated adjuvant radiation therapy clinical trial, also known as DART, for patients with HPV oropharynx cancer. In the previous trial, DART was associated with a 33% reduction in cost for radiation therapy as well as a 21% reduction in overall treatment cost for patients with oropharynx cancer. The benefit to patients of a two-week course of treatment instead of a six-week course of treatment is tremendous, especially for patients with limited social and financial resources. Importantly, this study also allows for de-escalation of patients who primarily receive radiotherapy without surgery based on biomarker response during chemoradiotherapy.

The primary goal of the DART 2.0 study is to prospectively incorporate ctHPVDNA in combination with clinical and pathological factors to appropriately select treatment intensity for patients who have surgery and those who don't.

For more information about the DART 2.0 clinical trial, please visit the Mayo clinical trials, ClinicalTrials.gov and National Cancer Institute webpages.