Stereotactic Body Radiation for Consolidation After Standard Chemoradiation for Stage 3 Lung Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Early and Intermediate Toxicity for Dose Limiting Toxicity
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and toxicity stereotactic body radiation (SBRT) as consolidation following standard chemoradiation for patients with stage III non-small cell lung cancer.
详细描述
This protocol will investigate the potential role of SBRT for patients with stage 3 NSCLC. Eligible patients will first have received standard 50.4 Gy chemoradiation. Patients entering the study will have the opportunity to receive SBRT as a noninvasive option as compared to surgical resection. For patients who are not surgical candidates, SBRT after 50.4 Gy chemoradiation represents a technique of radiation consolidation that may be more effective and less toxic than standard conventional fractionated radiation
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •PATIENT ELIGIBILITY Conditions for Patient Eligibility (Inclusion)
- •Pathologically or cytologically confirmed NSCLC
- •Stage III NSCLC according to the AJCC 7th edition staging criteria. Stage II (T1-3N1) patient that are deemed medically inoperable are also eligible.
- •Concurrent chemoradiation to a radiation dose of 50.4 Gy.
- •residual tumor volume after concurrent chemoradiation that is appropriate for SBRT:
- •Primary tumor <120cc (approximately 6cm diameter).
- •Mediastinal/Hilar disease: 1-2 involved regions <60cc (approximately 5cmx3cmx3cm)
- •Absolute neutrophil count ≥ 1,000/uL, platelet ≥ 60,000/uL.
- •Total bilirubin ≤ 2x upper institutional limit of normal (ULN), and AST or ALT ≤5x ULN.
- •ECOG performance status 0 to 2
- •Minimum life expectancy of 12 weeks.
- •Age older than 18 years.
- •Voluntary, signed written informed consent.
- •Women of childbearing potential must have a negative pregnancy test
- •Men and women of childbearing potential must be willing to consent to using effective contraception while on treatment and for at least 1 months thereafter.
- •Conditions for Patient Ineligibility (Exclusion)
- •Disease progression during or after standard chemoradiation to 50.4 Gy
- •Prior thoracic radiation other than the pre-operative radiation not greater than 50.4
- •Metastatic disease
- •Uncontrolled severe, intercurrent illness.
- •Women who are breast-feeding.
- •No chemotherapy within 2 weeks from the first SBRT treatment.
- •Concurrent anticancer therapy.
- •Prior complete resection of all NSCLC.
排除标准
- 未提供
研究组 & 干预措施
Stereotactic radiation Arm 3
3 24 Gy
干预措施: Stereotactic radiation Arm 3 (Radiation)
Stereotactic radiation Arm 4
4 28 Gy
干预措施: Stereotactic radiation Arm 4 (Radiation)
Stereotactic radiation Arm 1
Dose Levels/total Dose
1 16 Gy
干预措施: Stereotactic radiation Arm 1 (Radiation)
Stereotactic radiation Arm 2
2 20 Gy
干预措施: Stereotactic radiation Arm 2 (Radiation)
结局指标
主要结局
Early and Intermediate Toxicity for Dose Limiting Toxicity
时间窗: 3 months
Any toxicity related to the radiation treatment will be scored and graded using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Serious adverse events will be captured from the time the patient signs consent until 12 weeks after the last SBRT. DLTS: defined in protocol as: Dose limiting toxicities will be defined as grade 3 or greater treatment related pneumonitis, cardiac toxicity, bronchial injury or chest wall pain during or within 4 weeks of completion of SBRT.
次要结局
未报告次要终点
研究者
Dr Thomas DiPetrillo
Prinicipal Investigator
Brown University