Feasibility and Outcome of Cyberknife® Precision Hypofractionated Radiosurgery for the Curative Management of Non-Small Cell Lung Cancer
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- Participants Who Did Not Experience a Dose Limiting Toxicity in the Less Than 3 Centimeter Cohort
研究概览
简要总结
RATIONALE: Stereotactic radiosurgery can send x-rays directly to the tumor and cause less damage to normal tissue.
PURPOSE: This phase I trial is studying the side effects and best dose of stereotactic radiosurgery in treating patients with stage I or stage II non-small cell lung cancer.
详细描述
OBJECTIVES:
- To establish the maximum tolerated dose of CyberKnife® hypofractionated stereotactic radiosurgery in patients with medically inoperable, stage I or II non-small cell lung cancer.
- To establish the relationship between positron emission tomography (PET) response and local control and survival using fludeoxyglucose F 18 PET/CT imaging before treatment and at 1, 3, 6, and 12 months after treatment.
OUTLINE: Patients undergo placement of 3 gold fiducial markers by CT-guidance or bronchoscopy. Patients then undergo CyberKnife® hypofractionated stereotactic radiosurgery over 45-120 minutes twice weekly for 2 weeks.
Patients undergo fludeoxyglucose F 18 PET/CT scan at baseline and at 1, 3, 6, and 12 months after completion of treatment.
After completion of study treatment, patients are followed periodically for up to 4 years.
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
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed non-small cell lung cancer
- •Stage I or II disease (T1-3, N0, M0)
- •T2 or T3 tumor ≤ 5 cm
- •No T3 tumors involving the central chest or mediastinum (only chest wall involvement allowed)
- •Tumor deemed technically resectable, in the opinion of an experienced thoracic surgeon, AND patient deemed "medically inoperable"
- •Patients with fluorodeoxyglucose (FDG)-avidity in mediastinal lymph nodes are eligible provided they are able to undergo mediastinoscopy to confirm N0 status
- •PATIENT CHARACTERISTICS:
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- •Not pregnant or nursing
- •Fertile patients must use effective contraception during and for ≥ 6 months after completion of study treatment
排除标准
- •No history of contrast allergy
- •No psychological issues that would preclude the completion of study treatment
- •PRIOR CONCURRENT THERAPY:
- •No prior radiotherapy or chemotherapy
- •No suspected nodal metastasis that cannot be falsified by mediastinoscopy (i.e., hilar or mediastinal nodes that are either fludeoxyglucose F 18 [FDG]-avid or measure > 1 cm in short axis diameter on CT scan)
- •No tumor within or touching the proximal bronchial tree, defined as a volume of 2 cm in all directions around the proximal bronchial tree (carina, right and left main stem bronchi, right and left upper lobe bronchi, bronchus intermedius, right middle lobe bronchus, lingular bronchus, right and left lower lobe bronchi)
研究组 & 干预措施
56 Gray (LESS than 3 centimeter cohort)
Intervention:
Procedure/Surgery: computed tomography Standard CT scans
Intervention:
Radiation: fludeoxyglucose F 18 standard doses with CT scans
Radiation: hypofractionated radiation therapy 4 doses over 2 weeks - 56 Gray
Radiation: stereotactic radiosurgery CyberKnife radiosurgery
干预措施: stereotactic radiosurgery (Radiation)
56 Gray (LESS than 3 centimeter cohort)
Intervention:
Procedure/Surgery: computed tomography Standard CT scans
Intervention:
Radiation: fludeoxyglucose F 18 standard doses with CT scans
Radiation: hypofractionated radiation therapy 4 doses over 2 weeks - 56 Gray
Radiation: stereotactic radiosurgery CyberKnife radiosurgery
干预措施: computed tomography (Procedure)
56 Gray (LESS than 3 centimeter cohort)
Intervention:
Procedure/Surgery: computed tomography Standard CT scans
Intervention:
Radiation: fludeoxyglucose F 18 standard doses with CT scans
Radiation: hypofractionated radiation therapy 4 doses over 2 weeks - 56 Gray
Radiation: stereotactic radiosurgery CyberKnife radiosurgery
干预措施: fludeoxyglucose F 18 (Radiation)
56 Gray (LESS than 3 centimeter cohort)
Intervention:
Procedure/Surgery: computed tomography Standard CT scans
Intervention:
Radiation: fludeoxyglucose F 18 standard doses with CT scans
Radiation: hypofractionated radiation therapy 4 doses over 2 weeks - 56 Gray
Radiation: stereotactic radiosurgery CyberKnife radiosurgery
干预措施: hypofractionated radiation therapy (Radiation)
62 Gray (LESS than 3 centimeter cohort)
Intervention:
Procedure/Surgery: computed tomography Standard CT scans
Intervention:
Radiation: fludeoxyglucose F 18 standard doses with CT scans
Radiation: hypofractionated radiation therapy 4 doses over 2 weeks - 62 Gray
Radiation: stereotactic radiosurgery CyberKnife radiosurgery
干预措施: computed tomography (Procedure)
62 Gray (LESS than 3 centimeter cohort)
Intervention:
Procedure/Surgery: computed tomography Standard CT scans
Intervention:
Radiation: fludeoxyglucose F 18 standard doses with CT scans
Radiation: hypofractionated radiation therapy 4 doses over 2 weeks - 62 Gray
Radiation: stereotactic radiosurgery CyberKnife radiosurgery
干预措施: fludeoxyglucose F 18 (Radiation)
62 Gray (LESS than 3 centimeter cohort)
Intervention:
Procedure/Surgery: computed tomography Standard CT scans
Intervention:
Radiation: fludeoxyglucose F 18 standard doses with CT scans
Radiation: hypofractionated radiation therapy 4 doses over 2 weeks - 62 Gray
Radiation: stereotactic radiosurgery CyberKnife radiosurgery
干预措施: hypofractionated radiation therapy (Radiation)
62 Gray (LESS than 3 centimeter cohort)
Intervention:
Procedure/Surgery: computed tomography Standard CT scans
Intervention:
Radiation: fludeoxyglucose F 18 standard doses with CT scans
Radiation: hypofractionated radiation therapy 4 doses over 2 weeks - 62 Gray
Radiation: stereotactic radiosurgery CyberKnife radiosurgery
干预措施: stereotactic radiosurgery (Radiation)
68 Gray (LESS than 3 centimeter cohort)
Intervention:
Procedure/Surgery: computed tomography Standard CT scans
Intervention:
Radiation: fludeoxyglucose F 18 standard doses with CT scans
Radiation: hypofractionated radiation therapy 4 doses over 2 weeks - 68 Gray
Radiation: stereotactic radiosurgery CyberKnife radiosurgery
干预措施: computed tomography (Procedure)
68 Gray (LESS than 3 centimeter cohort)
Intervention:
Procedure/Surgery: computed tomography Standard CT scans
Intervention:
Radiation: fludeoxyglucose F 18 standard doses with CT scans
Radiation: hypofractionated radiation therapy 4 doses over 2 weeks - 68 Gray
Radiation: stereotactic radiosurgery CyberKnife radiosurgery
干预措施: fludeoxyglucose F 18 (Radiation)
68 Gray (LESS than 3 centimeter cohort)
Intervention:
Procedure/Surgery: computed tomography Standard CT scans
Intervention:
Radiation: fludeoxyglucose F 18 standard doses with CT scans
Radiation: hypofractionated radiation therapy 4 doses over 2 weeks - 68 Gray
Radiation: stereotactic radiosurgery CyberKnife radiosurgery
干预措施: hypofractionated radiation therapy (Radiation)
68 Gray (LESS than 3 centimeter cohort)
Intervention:
Procedure/Surgery: computed tomography Standard CT scans
Intervention:
Radiation: fludeoxyglucose F 18 standard doses with CT scans
Radiation: hypofractionated radiation therapy 4 doses over 2 weeks - 68 Gray
Radiation: stereotactic radiosurgery CyberKnife radiosurgery
干预措施: stereotactic radiosurgery (Radiation)
56 Gray (MORE than 3 centimeter cohort)
Intervention:
Procedure/Surgery: computed tomography Standard CT scans
Intervention:
Radiation: fludeoxyglucose F 18 standard doses with CT scans
Radiation: hypofractionated radiation therapy 4 doses over 2 weeks - 56 Gray
Radiation: stereotactic radiosurgery CyberKnife radiosurgery
干预措施: computed tomography (Procedure)
56 Gray (MORE than 3 centimeter cohort)
Intervention:
Procedure/Surgery: computed tomography Standard CT scans
Intervention:
Radiation: fludeoxyglucose F 18 standard doses with CT scans
Radiation: hypofractionated radiation therapy 4 doses over 2 weeks - 56 Gray
Radiation: stereotactic radiosurgery CyberKnife radiosurgery
干预措施: fludeoxyglucose F 18 (Radiation)
56 Gray (MORE than 3 centimeter cohort)
Intervention:
Procedure/Surgery: computed tomography Standard CT scans
Intervention:
Radiation: fludeoxyglucose F 18 standard doses with CT scans
Radiation: hypofractionated radiation therapy 4 doses over 2 weeks - 56 Gray
Radiation: stereotactic radiosurgery CyberKnife radiosurgery
干预措施: hypofractionated radiation therapy (Radiation)
56 Gray (MORE than 3 centimeter cohort)
Intervention:
Procedure/Surgery: computed tomography Standard CT scans
Intervention:
Radiation: fludeoxyglucose F 18 standard doses with CT scans
Radiation: hypofractionated radiation therapy 4 doses over 2 weeks - 56 Gray
Radiation: stereotactic radiosurgery CyberKnife radiosurgery
干预措施: stereotactic radiosurgery (Radiation)
62 Gray (MORE than 3 centimeter cohort)
Intervention:
Procedure/Surgery: computed tomography Standard CT scans
Intervention:
Radiation: fludeoxyglucose F 18 standard doses with CT scans
Radiation: hypofractionated radiation therapy 4 doses over 2 weeks - 62 Gray
Radiation: stereotactic radiosurgery CyberKnife radiosurgery
干预措施: computed tomography (Procedure)
62 Gray (MORE than 3 centimeter cohort)
Intervention:
Procedure/Surgery: computed tomography Standard CT scans
Intervention:
Radiation: fludeoxyglucose F 18 standard doses with CT scans
Radiation: hypofractionated radiation therapy 4 doses over 2 weeks - 62 Gray
Radiation: stereotactic radiosurgery CyberKnife radiosurgery
干预措施: fludeoxyglucose F 18 (Radiation)
62 Gray (MORE than 3 centimeter cohort)
Intervention:
Procedure/Surgery: computed tomography Standard CT scans
Intervention:
Radiation: fludeoxyglucose F 18 standard doses with CT scans
Radiation: hypofractionated radiation therapy 4 doses over 2 weeks - 62 Gray
Radiation: stereotactic radiosurgery CyberKnife radiosurgery
干预措施: hypofractionated radiation therapy (Radiation)
62 Gray (MORE than 3 centimeter cohort)
Intervention:
Procedure/Surgery: computed tomography Standard CT scans
Intervention:
Radiation: fludeoxyglucose F 18 standard doses with CT scans
Radiation: hypofractionated radiation therapy 4 doses over 2 weeks - 62 Gray
Radiation: stereotactic radiosurgery CyberKnife radiosurgery
干预措施: stereotactic radiosurgery (Radiation)
68 Gray (MORE than 3 centimeter cohort)
Intervention:
Procedure/Surgery: computed tomography Standard CT scans
Intervention:
Radiation: fludeoxyglucose F 18 standard doses with CT scans
Radiation: hypofractionated radiation therapy 4 doses over 2 weeks - 68 Gray
Radiation: stereotactic radiosurgery CyberKnife radiosurgery
干预措施: computed tomography (Procedure)
68 Gray (MORE than 3 centimeter cohort)
Intervention:
Procedure/Surgery: computed tomography Standard CT scans
Intervention:
Radiation: fludeoxyglucose F 18 standard doses with CT scans
Radiation: hypofractionated radiation therapy 4 doses over 2 weeks - 68 Gray
Radiation: stereotactic radiosurgery CyberKnife radiosurgery
干预措施: fludeoxyglucose F 18 (Radiation)
68 Gray (MORE than 3 centimeter cohort)
Intervention:
Procedure/Surgery: computed tomography Standard CT scans
Intervention:
Radiation: fludeoxyglucose F 18 standard doses with CT scans
Radiation: hypofractionated radiation therapy 4 doses over 2 weeks - 68 Gray
Radiation: stereotactic radiosurgery CyberKnife radiosurgery
干预措施: hypofractionated radiation therapy (Radiation)
68 Gray (MORE than 3 centimeter cohort)
Intervention:
Procedure/Surgery: computed tomography Standard CT scans
Intervention:
Radiation: fludeoxyglucose F 18 standard doses with CT scans
Radiation: hypofractionated radiation therapy 4 doses over 2 weeks - 68 Gray
Radiation: stereotactic radiosurgery CyberKnife radiosurgery
干预措施: stereotactic radiosurgery (Radiation)
结局指标
主要结局
Participants Who Did Not Experience a Dose Limiting Toxicity in the Less Than 3 Centimeter Cohort
时间窗: 6 weeks
Number of Participants Who Did Not Experience a Dose Limiting Toxicity in the less than 3 centimeter cohort
Participants Who Did Not Experience a Dose Limiting Toxicity in the More Than 3 Centimeter Cohort
时间窗: 6 weeks
The number of participants that did not experience a dose-limiting toxicity in the greater than 3 centimeter cohort
Maximum Tolerated Dose in the Less Than 3 Centimeter Cohort
时间窗: 6 weeks
The highest tolerable dose between 56 gray, 62 gray and 68 gray has not been established as the protocol was terminated early.
Maximum Tolerated Dose - More Than 3 Centimeter Cohort.
时间窗: 6 weeks
The highest tolerable dose between 56 gray, 62 gray and 68 gray has not been established as the protocol was terminated early.
次要结局
- Relationship Between Positron Emission Tomography (PET) Response and Local Control and Survival(before treatment and at 1, 3, 6, and 12 months after treatment)
研究者
Minh Tam Truong
Chair and Associate Professor, Radiation Oncology
Boston Medical Center