NCT02761408Unknown不适用
Correlation Between Radiation Dermatitis/Mucositis and ALDH2 Mutation in Taiwanese Head and Neck Cancer
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Number of participants with treatment-related adverse events assessed by CTCAEv5.0
研究概览
简要总结
The purpose of this study is to evaluate the effect of ALDH2 mutation in radiation associating dermatitis or mucositis in head and neck cancer patients who accept chemoradiation therapy
详细描述
- One-site audit. The enrolled subject is confirmed by PIs
◦◦Source data is compared to external data sources medical records, either paper or electronic case report forms.
- NCI CTCAE v5.0 for AE records
- Patient recruitment according to inclusion criteria: 1. Newly diagnosed locally head and neck squamous cell carcinoma; 2. Apply for primary chemoradiation or adjuvant chemoradiation; 3. Signed informed consent
- Sample size assessment: 60 subjects will be included in one year for total 120 subjects
- Missing data to address situations where variables are reported as missing, unavailable, "non-reported," uninterpretable, or considered missing because of data inconsistency or out-of-range results
- Fisher's exact test is for category comparison. Kaplan-Meier analysis is for survival analysis. AE grades will be analyzed according to NCI guideline. Two-side p < 0.05 is suggested significant.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 21 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >20, <70
- •Newly diagnosed head and neck squamous cell carcinoma
- •Tissue proved
- •Signed informed consent
- •Suitable for chemoradiation
排除标准
- •Uncontrolled underlying diseases
- •Allergy to chemotherapy
- •Uncontrolled skin diseases or mucosa diseases
- •Previously radiation therapy over head and neck
- •Combined with other cancer currently
结局指标
主要结局
Number of participants with treatment-related adverse events assessed by CTCAEv5.0
时间窗: 6 months after the end of the study
The side effects of each participant will be recorded accoiding to CTCAEv5.0 during the whole course of chemoradiation, by indicated physicians regularly
次要结局
未报告次要终点
研究者
研究点 (1)
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