Stereotactic Body Radiation for Consolidation After Standard Chemoradiation for Stage 3 Lung Cancer
研究概览
地位
条件
详细说明
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
-
-
Rhode Island
-
Pawtucket、Rhode Island、美国、02860
- Memorial Hospital of Rhode Island
-
Providence、Rhode Island、美国、02903
- Rhode Island Hospital
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
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.
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:非随机化
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
实验性的:Stereotactic radiation Arm 1
Dose Levels/total Dose 1 16 Gy |
Dose Levels Dose per Fraction Total Dose 1 8 Gy 16 Gy |
实验性的:Stereotactic radiation Arm 2
2 20 Gy
|
Dose Levels Dose per Fraction Total Dose 2 10 Gy 20 Gy
|
实验性的:Stereotactic radiation Arm 3
3 24 Gy
|
Dose Levels Dose per Fraction Total Dose 3 12 Gy 24 Gy
|
实验性的:Stereotactic radiation Arm 4
4 28 Gy
|
Dose Levels Dose per Fraction Total Dose 4 14 Gy 28 Gy
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Early and Intermediate Toxicity for Dose Limiting Toxicity
大体时间: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. |
3 months
|
合作者和调查者
调查人员
- 学习椅:Howard Safran, MD、BrUOG Study Chair
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
Stereotactic radiation Arm 1的临床试验
-
GE HealthcareQuintiles, Inc.; Covance; ABX CRO; Examination Management Services Inc.; Averion International Corporation终止
-
Children's Hospital of PhiladelphiaNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); Boston Children's... 和其他合作者完全的
-
Duke UniversityNational Institute of Allergy and Infectious Diseases (NIAID); Moi University; Clinton Health...完全的
-
University of Massachusetts, WorcesterPfizer; Reliant Medical Group完全的
-
University of Colorado, DenverNational Institute on Drug Abuse (NIDA)完全的