Phase I Dose Escalation Study of a Hypofractionated Stereotactic Boost (HySBst) to the Primary Site in Patients With Stage II-III Non-small Cell Lung Cancer
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Maximum Tolerated Dose of HySBst
研究概览
简要总结
This study will help researchers test the safety of hypofractionated dose of radiotherapy (HySBst) at different dose levels before or after chemo-radiation for Non Small Cell Lung Cancer.
详细描述
Patients are assigned to Sub-group 1 or 2 based on the primary lesion size and location. This protocol will utilize a standard 3 + 3 phase I design with three patients enrolled per cohort.
Patients will be offered the opportunity to participate in the blood specimen component of the study.
Patients will be followed up to 2 years post radiation therapy.
Sub-group 1 will receive HySBst for 1 week. Weeks 2-7 will be standard chemo-radiation therapy. Patients have the option of consolidative chemotherapy at week 12.
Sub-group 2 will receive standard chemo-radiation therapy for weeks 1-6 then receive HySBst during week 7. Patients have the option of consolidative chemotherapy at week 12.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Stage II - III Non Small Cell Lung Cancer
排除标准
- •Primary tumor directly invading into any mediastinal structures, such as the heart, major blood vessels, esophagus, trachea, and the proximal bronchial tree.
- •Prior chemotherapy for NSCLC
- •Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields.
- •Severe, active co-morbidity
- •Pregnancy or women of childbearing potential
- •Any history of allergic reaction to paclitaxel or other taxanes, or to carboplatin
- •Uncontrolled neuropathy ≥ grade 2.
研究组 & 干预措施
Sub-group 1
HySBst to be delivered during week 1 with Chemo-radiation to be delivered weeks 2-7
干预措施: Hypofractionated Stereotactic Boost (Radiation)
Sub-group 1
HySBst to be delivered during week 1 with Chemo-radiation to be delivered weeks 2-7
干预措施: Carboplatin (Drug)
Sub-group 1
HySBst to be delivered during week 1 with Chemo-radiation to be delivered weeks 2-7
干预措施: Paclitaxel (Drug)
Sub-group 1
HySBst to be delivered during week 1 with Chemo-radiation to be delivered weeks 2-7
干预措施: Image-guided IMRT (Radiation)
Sub-group 2
Chemo-radiation to be delivered weeks 1-6 and HySBst to be delivered week 7
干预措施: Hypofractionated Stereotactic Boost (Radiation)
Sub-group 2
Chemo-radiation to be delivered weeks 1-6 and HySBst to be delivered week 7
干预措施: Carboplatin (Drug)
Sub-group 2
Chemo-radiation to be delivered weeks 1-6 and HySBst to be delivered week 7
干预措施: Paclitaxel (Drug)
Sub-group 2
Chemo-radiation to be delivered weeks 1-6 and HySBst to be delivered week 7
干预措施: Image-guided IMRT (Radiation)
结局指标
主要结局
Maximum Tolerated Dose of HySBst
时间窗: 2 years
次要结局
- Dose Limiting Toxicity(1 week)
- Blood Sample Collection(2 years)
- Local Control(2 years)
- Quality of Life(2 years)