Efficacy Evaluation of the Combination of Valproic Acid and Standard Platinum-based Chemoradiation in Patients With Locally Advanced Head and Neck Squamous Cell Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Response Rate
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
valproic acid
干预措施: Valproic Acid (Drug)
结局指标
主要结局
Response Rate
时间窗: Within 6 to 8 weeks after completion of chemoradiation
RECIST v 1.1
次要结局
- Progression free survival(Three years)
- Adverse reactions to study treatment
- Overall survival(Three Years)
- Response rate comparison by p16 status
- Quality of life
研究者
Milena Mak
MD
Instituto do Cancer do Estado de São Paulo