Three Pilot Studies of Stereotactic Body Radiation Therapy (SBRT) and Surgery in Non-small Cell Lung Cancer
试验速览
- 阶段
- 早期 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Incidence of treatment-related grade 3-5 adverse events assessed using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v)4.0
研究概览
简要总结
This pilot clinical trial studies the effects of stereotactic body radiation therapy followed by surgery in treating patients with stage I-IIIA non-small cell lung cancer. Stereotactic body radiation therapy is a method of radiation that uses imaging to precisely locate a tumor and then deliver very high radiation doses to the tumor site in order to limit normal tissue toxicity or damage.
详细描述
PRIMARY OBJECTIVES:
I. To assess the safety and feasibility of combining single fraction stereotactic body radiation therapy (SBRT) followed by surgery, in thoracic malignancies.
SECONDARY OBJECTIVES:
I. To estimate overall survival (OS) and progression-free survival (PFS) after single fraction SBRT followed by surgery, in thoracic malignancies.
II. To define any differences in quality of life/toxicity following SBRT based on tumor location/stage/tumor type.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Have an Eastern Cooperative Oncology Group (ECOG) performance status of =< 2
- •Have histologically proven diagnosis of: non-small cell lung cancer (NSCLC) (stage I, II, or IIIa)
- •Neoadjuvant or induction chemotherapy or biological (immune, vaccine, etc.)therapy for stage IIIa is allowed
- •Chemotherapy for another invasive malignancy is permitted if it has been treated definitively and the patient has remained disease free for >3 years
- •Participant is able to undergo surgery (planned lobectomy or wedge resection)
- •Specifically, the participant has been or will have been cleared for surgery at the time of enrollment; the surgeon can accept the baseline tests done within 45 days prior to SBRT to clear the patient for surgery
- •Participants of child-bearing potential must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) during treatment
- •Participant or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure
排除标准
- •Contraindication to SBRT (this includes the inability to cooperate with any aspect of SBRT: such as the inability to lie still and breathe reproducibly)
- •Previous radiotherapy to the volume of lung or mediastinum currently involved by tumor
- •Previous surgery for this lung or mediastinum tumor
- •Plans for the patient to receive other concomitant antineoplastic therapy (including standard fractionated radiotherapy, chemotherapy, biological therapy, vaccine therapy, and surgery) while on this protocol(does not apply to neoadjuvant therapy as in inclusion criteria) except at disease progression
- •Patients with active systemic, pulmonary, or pericardial infection
- •Pregnant or nursing female participants
- •Unwilling or unable to follow protocol requirements
- •Any condition which in the investigator?s opinion deems the participant ineligible
- •Received an investigational agent within 30 days prior to enrollment
- •Stage IIIb
研究组 & 干预措施
Study 1 (highest-dose of SBRT, surgery)
Patients with stage I or II NSCLC in the peripheral lung undergo highest-dose of Stereotactic Body Radiation Therapy over a single treatment fraction on day 1. Patients then undergo thoracic surgery on day 28.
干预措施: Laboratory Biomarker Analysis (Other)
Study 1 (highest-dose of SBRT, surgery)
Patients with stage I or II NSCLC in the peripheral lung undergo highest-dose of Stereotactic Body Radiation Therapy over a single treatment fraction on day 1. Patients then undergo thoracic surgery on day 28.
干预措施: Quality-of-Life Assessment (Other)
Study 1 (highest-dose of SBRT, surgery)
Patients with stage I or II NSCLC in the peripheral lung undergo highest-dose of Stereotactic Body Radiation Therapy over a single treatment fraction on day 1. Patients then undergo thoracic surgery on day 28.
干预措施: Stereotactic Body Radiation Therapy (Drug)
Study 1 (highest-dose of SBRT, surgery)
Patients with stage I or II NSCLC in the peripheral lung undergo highest-dose of Stereotactic Body Radiation Therapy over a single treatment fraction on day 1. Patients then undergo thoracic surgery on day 28.
干预措施: Thoracic Surgical Procedure (Procedure)
Study 2 (lowest-dose of SBRT, surgery)
Patients with stage I or II NSCLC in the central lung undergo lowest-dose of Stereotactic Body Radiation Therapy over a single treatment fraction on day 1. Patients then undergo thoracic surgery on day 28.
干预措施: Laboratory Biomarker Analysis (Other)
Study 2 (lowest-dose of SBRT, surgery)
Patients with stage I or II NSCLC in the central lung undergo lowest-dose of Stereotactic Body Radiation Therapy over a single treatment fraction on day 1. Patients then undergo thoracic surgery on day 28.
干预措施: Quality-of-Life Assessment (Other)
Study 2 (lowest-dose of SBRT, surgery)
Patients with stage I or II NSCLC in the central lung undergo lowest-dose of Stereotactic Body Radiation Therapy over a single treatment fraction on day 1. Patients then undergo thoracic surgery on day 28.
干预措施: Stereotactic Body Radiation Therapy (Drug)
Study 2 (lowest-dose of SBRT, surgery)
Patients with stage I or II NSCLC in the central lung undergo lowest-dose of Stereotactic Body Radiation Therapy over a single treatment fraction on day 1. Patients then undergo thoracic surgery on day 28.
干预措施: Thoracic Surgical Procedure (Procedure)
Study 3 (lowest- or higher-dose of SBRT, surgery)
Patients with stage IIIA NSCLC in the any lung location undergo lowest- or higher-dose of Stereotactic Body Radiation Therapy over a single treatment fraction on day 1. Patients then undergo thoracic surgery on day 28.
干预措施: Laboratory Biomarker Analysis (Other)
Study 3 (lowest- or higher-dose of SBRT, surgery)
Patients with stage IIIA NSCLC in the any lung location undergo lowest- or higher-dose of Stereotactic Body Radiation Therapy over a single treatment fraction on day 1. Patients then undergo thoracic surgery on day 28.
干预措施: Quality-of-Life Assessment (Other)
Study 3 (lowest- or higher-dose of SBRT, surgery)
Patients with stage IIIA NSCLC in the any lung location undergo lowest- or higher-dose of Stereotactic Body Radiation Therapy over a single treatment fraction on day 1. Patients then undergo thoracic surgery on day 28.
干预措施: Stereotactic Body Radiation Therapy (Drug)
Study 3 (lowest- or higher-dose of SBRT, surgery)
Patients with stage IIIA NSCLC in the any lung location undergo lowest- or higher-dose of Stereotactic Body Radiation Therapy over a single treatment fraction on day 1. Patients then undergo thoracic surgery on day 28.
干预措施: Thoracic Surgical Procedure (Procedure)
结局指标
主要结局
Incidence of treatment-related grade 3-5 adverse events assessed using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v)4.0
时间窗: Up to 10 weeks post-surgery
Comparison will be made with published historical and contemporaneous rates of toxicity with standard of care therapy for each of the study groups.
次要结局
- Overall survival(Up to 5 years)
- Progression free survival(Up to 5 years)