Feasibility Study of Stereotactic Body Radiation Therapy Followed by Wedge Resection for Peripherally Located Early Stage Non-small Cell Lung Cancer
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Rate of grade 3-5 adverse events, graded according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03
研究概览
简要总结
This pilot clinical trial studies the side effects and how well stereotactic radiosurgery followed by wedge resection works in treating patients with early stage non-small cell lung cancer that is located in the outer, or peripheral, areas of the lung. Stereotactic radiosurgery, also known as stereotactic body radiation therapy, is a specialized radiation therapy that delivers a single, high dose of radiation directly to the tumor and may kill more tumor cells and cause less damage to normal tissue. Wedge resection is a less invasive type of surgery for removal of the tumor and a small amount of normal tissue around it. Giving stereotactic radiosurgery followed by wedge resection may be a safe treatment option for patients who cannot receive standard treatment with lobectomy.
详细描述
PRIMARY OBJECTIVES:
I. To assess the safety and feasibility of a wedge resection following stereotactic body radiation therapy (SBRT) for early stage peripheral non-small cell lung cancer (NSCLC).
SECONDARY OBJECTIVES:
I. To assess pathologic response rates to SBRT as determined by pathologic examination of resected tumors.
II. To prospectively assess patient quality of life when treated with SBRT and wedge resection.
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
- •Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2
- •Biopsy proven non-small cell lung cancer
- •Maximum tumor dimension =< 5 cm
- •No clinical evidence of N1, N2 or N3 lymph nodes as assessed by CT and/or PET-CT
- •No evidence of distant metastatic disease
- •Tumor verified by a thoracic surgeon to be in a location that will permit a sublobar resection
- •Tumor located peripherally within the lung (peripheral defined as not touching any surface within 2 cm of the proximal bronchial tree in all directions) and not touching the mediastinal pleura
- •Pulmonary function tests (PFTs) with diffusing capacity of the lung for carbon monoxide (DLCO) within 90 days prior to registration
- •Patient at high-risk of complications from lobectomy meeting a minimum of one major criteria or two minor criteria as described below:
- •Major criteria
- •Predicted postoperative forced expiratory volume in one second (FEV1) =< 40%
- •Predicted postoperative DLCO =< 40%
- •Age >= 72
- •Minor criteria
- •Predicted postoperative FEV1 41-60%
- •Predicted postoperative DLCO 41-60%
- •Pulmonary hypertension (defined by a pulmonary artery systolic pressure greater than 40 mm Hg) as estimated by echocardiography or right heart catheterization
- •Poor left ventricular function (defined as an ejection fraction 40% or less)
- •Resting or exercising arterial partial pressure of oxygen (pO2) =< 55 mmHg or oxygen saturation (SpO2) =< 88%
- •Partial pressure of carbon monoxide (pCO2) > 45 mm Hg
- •Modified Medical Research Council Dyspnea Scale >= 3
- •Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
- •A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
- •Has not undergone a hysterectomy or bilateral oophorectomy; or
- •Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months)
- •Ability to understand and the willingness to sign a written informed consent
排除标准
- •Pregnant women
- •Patients with central tumors within the proximal tree or touching the mediastinal pleura
- •Patients with evidence of distant metastatic disease
结局指标
主要结局
Rate of grade 3-5 adverse events, graded according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03
时间窗: Up to 12 months after surgery
Treatment related toxicities will be assessed and recorded for each patient receiving treatment.
Rates of perioperative complications including blood loss, days in the intensive care unit, and operative time
时间窗: Up to 12 months after surgery
Feasibility, determined by the number of patients who are able to complete wedge resection as well as receive the full dose of stereotactic radiosurgery
时间窗: Up to 12 months after surgery
次要结局
- Pathologic response rates(Up to 12 months after surgery)
- Quality of life assessment(Up to 12 months after surgery)