NCT06080061招募中1 期
Phase I Trial of Personalized Accelerated ChEmoRadiation (PACER) for Lung Cancer
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 45
- 试验地点
- 3
- 主要终点
- Dose limiting pulmonary and esophageal toxicity
研究概览
简要总结
The purpose of this study is to examine the use of hypofractionated accelerated radiation therapy (HART) to treat locally advanced lung cancer. Depending on the location and size of the tumor.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically documented malignancy of the lung including non-small cell lung cancer or small cell lung cancer planned for definitive therapy with fractionated radiation (60-66 Gy) and concurrent systemic therapy
- •ECOG performance status of 0-2
- •Age > 18 years old
- •Ability to understand and the willingness to personally sign the written IRB approved informed consent document
- •Estimated life expectancy of 12 weeks or longer
排除标准
- •Contraindication to receiving radiotherapy or systemic therapy as determined by treating radiation and medical oncologist
- •Age < 18 years old
- •Tumor directly invading the major pulmonary arteries, aorta, heart or proximal bronchial tree
- •Diagnosis of interstitial pulmonary fibrosis
- •Previous radiation therapy to the thorax that would result in overlapping high dose radiation fields
结局指标
主要结局
Dose limiting pulmonary and esophageal toxicity
时间窗: 9 months
Toxicities will be scored by the CTCAE v5.0 criteria. Specific toxicities evaluated are grade 2+ pneumonitis and grade 3+ esophagitis as well as other G3+ pulmonary, esophageal or cardiac toxicities that could be probably or definitely attributed to rT.
次要结局
- Acute and Late Toxicities(36 months)
- Local control(36 months)
- Integrated adaptive dosing regimen with an automated planning system(36 months)
- Progression free survival(36 months)
- Overall survival(36 months)
研究者
研究点 (3)
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