Phase II Trial Of Induction Chemotherapy Followed By Attenuated Chemoradiotherapy For Locally Advanced Head And Neck Squamous Cell Carcinoma Associated With Human Papillomavirus (HPV)
Given the toxicity of high dose cisplatin, attention has focused on identifying patients at
lower risk for failure who may potentially benefit from less aggressive chemoradiotherapy
approaches. HPV-positive Head and Neck Cancer responds favorably to radiation therapy. This
has prompted investigators to suggest that patients with these cancers might be
"over-treated" and unnecessarily subjected to the toxicity of intensive chemoradiotherapy
with excessively high radiation doses.
This study will select patients with HPV-positive Head and Neck cancer for attenuated
therapy and may have important implications for individualization of care in the future. The
regimen of carboplatin and paclitaxel was selected for the induction chemotherapy phase
because of its ease of administration, improved toxicity profile, high rates of dose
delivery, and excellent published results showing high response rates and overall survival.
This study will use induction chemotherapy primarily as a means to select HPV-positive Head
and Neck Cancer patients, who may benefit from significant radiation dose de-intensification
in the concurrent chemoradiotherapy phase of treatment. The rationale for this risk-adapted
approach to local therapy based on HPV status is to administer effective comprehensive
treatment individualized at diagnosis and after assessment of response to induction
chemotherapy (for patients with HPV-positive tumors), thus avoiding unnecessary and
potentially toxic treatment, and hence optimizing the therapeutic ratio.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Defined from date of registration to date of first documentation of progression and/or distant metastasis, or death due to any cause.
Up to 2 years
Allen Chen, MD
University of California, Davis
United States: Institutional Review Board
|University of California Comprehensive Cancer Center||Sacramento, California 95817|