RTOG Foundation Study 3501
Status 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 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 |