Phase IB/II Trial Of Dose-Deescalated 3-Fraction Stereotactic Body Radiotherapy For Centrally Located Lung Cancer
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 36
- 试验地点
- 12
- 主要终点
- Safety of the stereotactic body radiotherapy regimen (SBRT)
研究概览
简要总结
The purpose of this trial is to test a deescalated 3-fraction stereotactic body radiotherapy (SBRT) regimen to 45 Gray (Gy) in 3 fractions for centrally located thoracic tumors.
详细描述
The purpose of this trial is to test a deescalated 3-fraction SBRT regimen to 45 Gy in 3 fractions for centrally located thoracic tumors in a phase II trial. This will provide prospectively collected data on the safety and efficacy of a three-fraction regimen in the previously defined "No Fly Zone" for both primary non-small cell lung cancer (NSCLC) and for lung metastases of any histology. This registration describes the design and eligibility criteria for the 36 NSCLC subjects the investigators plan to enroll. Local control, cancer-specific survival, and overall survival results from the NSCLC patients will be compared to both 3- and 5-fraction historical controls, specifically RTOG 0236 and 0813 results.
The outcomes of the metastatic patients will also be reported.
There will also be a quality-of-life component to the study to assess the impact of a shorter overall treatment time and the clinical impact of radiation side effects.
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
- •Lung tumors will be ≤ 5 cm and centrally located, meaning any portion of gross tumor volume located within 2 cm of (but not abutting) the proximal bronchial tree (trachea, carina, right and left main bronchi, right and left upper lobe bronchi, bronchus intermedius, right middle lobe bronchus, lingular bronchus, right and left lower lobe bronchi), or within 2 cm of (whether abutting or not) major vessels, esophagus, or heart (based on RTOG and MD Anderson Cancer Center definitions 33,34). Multiple concurrent isocenters are allowed if at least one tumor meets the above criteria, and if all dose constraints for the plan summation can be met. These concurrent tumors other than study target lesion can be treated as per SOC and does not necessarily have to meet the above size limit. The PI will review and prospectively approve any lesions abutting these organs.
- •ECOG Performance Status of 0-2
- •Patients must sign a study-specific consent form.
排除标准
- •Prior history of radiotherapy near target lesion resulting in overlapping treatment fields. Previously irradiated will be defined as OAR structures receiving the following doses (in <3Gy per fraction):
- •Spinal cord previously irradiated to > 40 Gy
- •Brachial plexus previously irradiated to > 50 Gy
- •Small intestine, large intestine, or stomach previously irradiated to > 45Gy
- •Brainstem previously irradiated to > 50 Gy
- •Lung previously irradiated with prior V20Gy > 35%
- •Active systemic, pulmonary, or pericardial infection
- •Interstitial pneumonia or extensive and symptomatic interstitial fibrosis of the lung
- •Pregnant or lactating
- •Any other medical condition or reason that, in the opinion of the investigator, would preclude study participation
研究组 & 干预措施
45 Gy
Deescalated 3-fraction stereotactic body radiotherapy regimen to 45 Gy in 3 fractions.
干预措施: 45 Gray (Gy) regimen (Radiation)
结局指标
主要结局
Safety of the stereotactic body radiotherapy regimen (SBRT)
时间窗: From administration of SBRT up to 2 years post-SBRT
Safety will be assessed by acute (defined as within 90 days of stereotactic body radiotherapy (SBRT)) and late (from 91 days through 2 years post-SBRT) toxicities. Toxicities are based on (Common Terminology Criteria for adverse events) CTCAE v. 5 criteria
local control (LC) of 3-fraction stereotactic body radiotherapy
时间窗: Up to 10 years post-enrollment.
The absence of primary tumor failure. Primary tumor failure is defined as Increase in tumor dimension of 20%.
次要结局
- lobar control(Up to 10 years post-enrollment.)
- overall survival(Up to 10 years post-enrollment.)
- progression-free survival(Up to 10 years post-enrollment.)
- regional control(Up to 10 years post-enrollment.)
- distant control(Up to 10 years post-enrollment.)