RTOG Foundation Study 3501

Study Date: September 21, 2022 | Status:  Terminated

TRYHARD

A Phase II, Randomized, Double Blind, Placebo-Controlled Study of Lapatinib (TYKERB®) for Non-HPV Locally Advanced Head and Neck Cancer with Concurrent Chemoradiation

Principal Investigator

Stuart J. Wong, MD

Primary Objective

To evaluate if the addition of lapatinib to concurrent cisplatin and radiation in this patient population sufficiently improves progression-free survival (PFS) to warrant a phase II trial.

Patient Population

Pathologically (histologically or cytologically) proven (from primary lesion and/or lymph nodes) diagnosis of Stage III or IV squamous cell carcinoma of the oropharynx, hypopharynx or larynx; for patients with an oropharynx primary site, the tumor must be negative for p16 by immunohistochemistry.

Participating Sites

Institution NameCityState/Country
Center at the University of LouisvilleLouisvilleKY
Emory UniversityAtlantaGA
James Graham Brown CancerLouisvilleKY
McGill UniversityMontrealQC
Medical College of WisconsinMilwaukeeWI
Ohio State University Medical CenterColumbusOH
Sutter General HospitalSacramentoCA
University Hospitals of ClevelandClevelandOH
University of Alabama at Birmingham Medical CenterBirminghamAL
University of California San DiegoLa JollaCA
University of California San FranciscoSan FranciscoCA
University of Oklahoma Health Sciences CenterOklahoma CityOK
University of Texas Southwestern Medical SchoolDallasTX
University of Texas-MD Anderson Cancer CenterHoustonTX
University of Wisconsin HospitalMadisonWI
Yale UniversityNew HavenCT