Title: TRYHARD: A Phase II, Randomized, Double Blind, Placebo-Controlled Study of Lapatinib (Tykerb®) for Non-HPV Locally Advanced Head and Neck Cancer With Concurrent Chemoradiation1
Principal Investigators: Stuart Wong, MD, Medical College of Wisconsin
Description: For this phase 2, randomized trial, researchers are evaluating whether lapatinib with cisplatin and radiation is safe and efficacious for patients with HPV-negative head and neck cancer.
The trial has 2 arms. In both arms patients will receive intensity-modulated radiation therapy and cisplatin. In the experimental arm only patients will also receive lapatinib.
The primary outcome is progression-free survival. Secondary outcomes include distant metastasis, adverse events, compliance, and overall survival.
The estimated study enrolment is 142 patients.
Lapatinib is an orally administered dual–tyrosine kinase inhibitor.
For more study information, including inclusion and exclusion criteria, study locations, and contact information, visit https://clinicaltrials.gov/ct2/show/NCT01711658.
Status: This study is open and recruiting patients as of July 12, 2017.
This study is sponsored by the Radiation Therapy Oncology Group in collaboration with GlaxoSmithKline, NRG Oncology, and Novartis.