An Alternative Radiation Fractionation Strategy for Locally Advanced Non-Small Cell Lung Cancer (NSCLC)
试验速览
- 阶段
- 1 期
- 入组人数
- 16
- 试验地点
- 4
- 主要终点
- Acute toxicities associated with this regimen using CTCAE v.4
研究概览
简要总结
This phase I trial studies the best dose of radiation therapy in treating patients with locally advanced non-small cell lung cancer that cannot be removed by surgery. Radiation therapy uses high energy x rays to kill tumor cells. Specialized radiation therapy, such as stereotactic body radiation therapy (SBRT), that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. SBRT has been shown to provide excellent results when used in early stage lung cancer, but has not yet been applied to patients with more advanced disease.
详细描述
PRIMARY OBJECTIVE:
To test the safety and tolerability of an alternative fractionation regimen in locally advanced non-small cell lung cancer (NSCLC), consisting of 44 Gy with concurrent chemotherapy followed by a stereotactic body radiation therapy (SBRT) boost to remaining parenchymal and nodal disease. The maximum tolerated dose of the SBRT boost will be determined.
SECONDARY OBJECTIVES:
- To assess local control.
- To assess distant metastasis and patterns of failure.
- To assess overall survival at 1 and 2 years.
OUTLINE: This is a dose-escalation study of radiation therapy and SBRT.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Biopsy proven NSCLC, within 8 weeks prior to patient registration
- •Unresectable disease
- •Clinical stage Tx, T1-T4, N1-3, M0
- •Karnofsky performance status (KPS) ≥ 70
- •Pretreatment positron emission tomography (PET) CT scan to rule out metastatic disease
- •The primary tumor may not be larger than 8 cm in maximum dimension
- •If the primary tumor is central in location, defined as within 2 cm from the tracheobronchial tree, it must be no larger than 5 cm
- •Mediastinal and hilar lymphadenopathy can be no larger than 5 cm at any nodal station
- •Pretreatment brain CT with contrast or brain MRI to rule out metastases
- •Pathologic assessment of the mediastinum to document involved nodal stations
- •All of the above inclusion criteria must occur within 8 weeks prior to patient registration, with the exception of pathologic assessment of the mediastinum and biopsy to confirm NSCLC, which can be done within 12 weeks of patient registration
排除标准
- •Prior history of lung cancer
- •Pregnancy
- •Prior history of radiation to the chest
研究组 & 干预措施
Treatment (radiation therapy, carboplatin, paclitaxel, SBRT)
Patients undergo radiation therapy daily and receive carboplatin and paclitaxel weekly for 4.5 weeks. Patients then undergo 2 boost SBRT treatments 2-3 days apart.
干预措施: stereotactic body radiation therapy (Radiation)
Treatment (radiation therapy, carboplatin, paclitaxel, SBRT)
Patients undergo radiation therapy daily and receive carboplatin and paclitaxel weekly for 4.5 weeks. Patients then undergo 2 boost SBRT treatments 2-3 days apart.
干预措施: carboplatin (Drug)
Treatment (radiation therapy, carboplatin, paclitaxel, SBRT)
Patients undergo radiation therapy daily and receive carboplatin and paclitaxel weekly for 4.5 weeks. Patients then undergo 2 boost SBRT treatments 2-3 days apart.
干预措施: paclitaxel (Drug)
Treatment (radiation therapy, carboplatin, paclitaxel, SBRT)
Patients undergo radiation therapy daily and receive carboplatin and paclitaxel weekly for 4.5 weeks. Patients then undergo 2 boost SBRT treatments 2-3 days apart.
干预措施: radiation therapy (Radiation)
结局指标
主要结局
Acute toxicities associated with this regimen using CTCAE v.4
时间窗: Up to 90 days
Crude rates of grade 3 and greater acute toxicities will be reported.
Late toxicities associated with this regimen using CTCAE v.4
时间窗: After 90 days
Crude rates of grade 3 and greater late toxicities will be reported.
Maximum tolerated dose (MTD) defined to be the dose level that results in a probability equal to 0.33 that a dose limiting toxicity (DLT) will be manifest using Common Terminology Criteria for Adverse Events (CTCAE) version 4 (v.4)
时间窗: Up to 1 year
次要结局
- Patterns of failure(Up to 5 years)
- Distant metastasis(Up to 5 years)
- Overall survival(At 5 years)
- Local control(Up to 5 years)
研究者
Kristin Higgins, MD
Principal Investigator
Emory University