TRYHARD: Radiation Therapy Plus Cisplatin With or Without Lapatinib in Treating Patients With Head and Neck Cancer.

Official 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 Chemoradiation

Summary:

PURPOSE: This trial is studying if and how well lapatinib adds to the effectiveness of radiation therapy plus cisplatin in patients who have head and neck cancer that is not related to the HPV virus.

Trial Description

Primary Outcome:

  • Progression-Free survival
Secondary Outcome:
  • Distant metastasis
  • Adverse Events
  • Compliance with planned treatment
  • Local-regional failure
  • Performance Status Scale for Head & Neck Cancer.
  • Functional Assessment of Cancer Therapy - Head & Neck.
  • University of Michigan Xerostomia-Related Quality of Life Scale.
  • HER2, EGFR, EMT as biomarkers of response.
  • Overall Survival

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society