The purpose of this study is to evaluate if the addition of valproic acid to standard platinum-based chemoradiation as definitive treatment of locally advanced Head and Neck squamous cell carcinoma can improve treatment outcomes, such as response rate.
Valproic acid is a known histone deacetylase inhibitor. In addition to activating apoptosis pathways, cell differentiation and downregulating expression of growth factors, it also promotes radiosensitization. Most patients with Head and Neck squamous cell carcinoma are diagnosed with locally advanced disease, in which long term disease control is still a challenge. The incorporation of epigenetic regulation into standard treatment could improve results of definitive platinum-based chemoradiation in such patients.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
14
Instituto do Cancer do Estado de Sao Paulo
São Paulo, São Paulo, Brazil
Response Rate
RECIST v 1.1
Time frame: Within 6 to 8 weeks after completion of chemoradiation
Adverse reactions to study treatment
Progression free survival
Time frame: Three years
Overall survival
Time frame: Three Years
Response rate comparison by p16 status
Quality of life
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