RTOG Foundation Study 3501

Status Date:  September 21, 2022  | Status:  Terminated


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 Name City State/Country
Center at the University of Louisville Louisville KY
Emory University Atlanta GA
James Graham Brown Cancer Louisville KY
McGill University Montreal QC
Medical College of Wisconsin Milwaukee WI
Ohio State University Medical Center Columbus OH
Sutter General Hospital Sacramento CA
University Hospitals of Cleveland Cleveland OH
University of Alabama at Birmingham Medical Center Birmingham AL
University of California San Diego La Jolla CA
University of California San Francisco San Francisco CA
University of Oklahoma Health Sciences Center Oklahoma City OK
University of Texas Southwestern Medical School Dallas TX
University of Texas-MD Anderson Cancer Center Houston TX
University of Wisconsin Hospital Madison WI
Yale University New Haven CT

Participate in RTOG Research

To participate as an RTOG study investigator, your organization must be part of the RTOG Foundation network. Patients who wish to participate in a study must be under the care of an RTOG participating investigator. For additional information, email info@rtog.org or call 1-215-574-3173.

See our clinical trials