Phase I/II Trial Evaluating Five Fraction SABR Dose Escalation for Early Stage Squamous Cell Carcinoma of the Lung
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 13
- 试验地点
- 3
- 主要终点
- Rate of dose limiting toxicities (DLTs) in each cohort during Phase 1
研究概览
简要总结
The purpose of this study is to test whether 5 fraction stereotactic ablative body radiation (SABR) is safe and improves local control for early state squamous cell carcinoma of the lung. While three fraction SABR is effective for the treatment of early stage non small cell lung carcinoma (NSCLC) of all histologies, it is not safe for many patients. While four and five fraction SABR is safe, recently published data and our institutional data suggests that local control for early stage squamous cell carcinoma of the lung using the current four or five fraction SABR is suboptimal.
详细描述
- Primary Objectives During Phase I study - Determine the safety and maximum tolerated radiation dose for five fraction SABR for squamous cell cancer of the lung.
During Phase II study - Determine 2 year local control of dose escalated five fraction SABR vs. institutional historical control standard dose SABR in squamous cell cancer of the lung. 2. Phase II Secondary Objectives
- Determine overall survival, progression free survival and patterns of failure after SABR.
- Determine tolerability of dose escalated SABR.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 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
- •Age ≥ 18 at time of consent.
- •Ability to provide written informed consent and HIPAA authorization.
- •Pathological diagnosis of squamous cell carcinoma of the lung.
- •Staging PET/CT (invasive mediastinal staging strongly encouraged but not required).
- •Tumors < 7cm
- •Any location eligible for SBRT (including, but not limited to, peripheral, chest wall abutting and central tumors)
- •N0 M0 disease
- •Plan to undergo four or five fraction SABR
- •Baseline PFTs available within 6 months of treatment start or will be obtained prior to treatment start (no finding will exclude patient from enrollment in trial)
排除标准
- •Previous radiation therapy to the lung per investigator discretion.
- •Inability to comply with treatment per investigator discretion.
- •Inability to follow standard of care follow up recommendations per investigator discretion.
研究组 & 干预措施
Phase 1/Dose Level 1
11 Gy will be given in 5 fractions for a total dose of 55 Gy
干预措施: Stereotactic Ablative Body Radiation (SABR) (Radiation)
Phase 1/Dose Level 2
12 Gy will be given in 5 fractions for a total dose of 60 Gy
干预措施: Stereotactic Ablative Body Radiation (SABR) (Radiation)
Phase 1/Dose Level 3
13 Gy will be given in 5 fractions for a total dose of 65 Gy
干预措施: Stereotactic Ablative Body Radiation (SABR) (Radiation)
Phase 1/Dose Level 4
14 Gy will be given in 5 fractions for a total dose of 70 Gy
干预措施: Stereotactic Ablative Body Radiation (SABR) (Radiation)
Phase 2
The maximum tolerated radiation dose determined during Phase 1 (i.e. 11, 12, 13, or 14 Gy) will be given in 5 fractions for a total dose of 55, 60, 65, or 70 Gy.
干预措施: Stereotactic Ablative Body Radiation (SABR) (Radiation)
结局指标
主要结局
Rate of dose limiting toxicities (DLTs) in each cohort during Phase 1
时间窗: 30 days
Any event per CTCAE v.4 that occurs within 30 days from the start of SABR, and is possibly, probably or definitely related to treatment, and is related to a specific list of symptoms which are outlined in the protocol.
次要结局
- Local control during Phase 2(2 years)
- Overall survival(2 years)
研究者
Tim Lautenschlaeger
Assistant Professor of Radiation Oncology
Indiana University