Head and Neck Cancer, Oral Cavity Cancer, Oropharyngeal Cancer
Conditions
Keywords
Head and Neck Cancer, Oropharyngeal cancer, Oral cavity cancer, Chemoradiation, valproic acid, histone deacetylase
Brief summary
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.
Detailed description
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.
Interventions
DRUGValproic Acid
Sponsors
University of Sao Paulo
Instituto do Cancer do Estado de São Paulo
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 65 Years
Healthy volunteers
No
Inclusion criteria
* Unresectable Oropharyngeal or oral cavity squamous cell carcinoma * Candidate for definitive chemoradiation * No previous treatment * Measurable disease according to RECIST v 1.1 * Previous neoplasia, other than Head and Neck, with more than five years without evidence of disease; basocellular carcinoma of the skin and in situ cervical dysplasia if resected * Age under 60 years * ECOG performance status 0-2 * Ability of understanding and giving informed consent * Adequate renal and hepatic function * Adequate bone marrow function * Normal serum magnesium * Absence of QTc prolongation * Life expectancy of over 12 weeks
Exclusion criteria
* Pregnancy * Distant metastasis * Hypersensibility to valproic acid or other antiepileptic drugs * Valproic acid chronic use * Severe neurologic impairment * Uncontrolled comorbidity * Hypoalbuminemia * Known history of hepatitis B, C or HIV
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Response Rate | Within 6 to 8 weeks after completion of chemoradiation | RECIST v 1.1 |
Secondary
| Measure | Time frame |
|---|---|
| Adverse reactions to study treatment | — |
| Progression free survival | Three years |
| Response rate comparison by p16 status | — |
| Quality of life | — |
| Overall survival | Three Years |
Other
| Measure | Time frame |
|---|---|
| Biomarkers assessment | — |
Countries
Brazil
Outcome results
None listed