A Phase II Randomized Study of 2 Stereotactic Body Radiation Therapy (SBRT) Regimens for Medically Inoperable Patients With Node Negative, Peripheral Non-Small Cell Lung Cancer
概览
- 阶段
- 2 期
- 干预措施
- 未指定
- 疾病 / 适应症
- Lung Cancer
- 发起方
- Roswell Park Cancer Institute
- 入组人数
- 98
- 试验地点
- 3
- 主要终点
- Incidence of AE Grade 3 or Higher Toxicity
- 状态
- 已完成
- 最后更新
- 4年前
概览
简要总结
RATIONALE: Stereotactic body radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue. It is not yet known which regimen of radiation therapy is more effective in treating patients with non-small cell lung cancer.
PURPOSE: This randomized phase II trial is studying the side effects of two radiation therapy regimens and to see how well they work in treating patients with stage I or stage II non-small cell lung cancer.
详细描述
OBJECTIVES: Primary * To compare the incidence of toxicity with two established stereotactic body radiotherapy (SBRT) regimens in patients with node-negative, peripheral stage I or II non-small cell lung cancer. Secondary * To compare quality of life, patterns of failure, disease-free survival, and overall survival of these patients after treatment with one of two established SBRT regimens. * To correlate outcomes and toxicities with imaging and patient and tumor biomarkers. OUTLINE: Patients are stratified according to Karnofsky performance status and treatment center. Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients undergo 1 high-dose fraction of stereotactic body radiotherapy (SBRT). * Arm II: Patients undergo 3 high-dose fractions (approximately 1 week apart) of SBRT. Quality of life is assessed periodically by the EORTC QLQ-C30 and -LC13 questionnaires Blood and tissue samples may be collected periodically and examined for biomarkers via ELISA and immunoblotting. After completion of study treatment, patients are followed for 5 years.
研究者
入排标准
入选标准
- •Histologically confirmed non-small cell lung cancer
- •T1-T2, N0 disease measuring ≤ 5 cm( T3 tumor based on chest wall involvement is Excluded)
- •Surgically resectable primary disease, however patient evaluated by thoracic oncologist and deemed medically inoperable OR patient refuses surgical resection
- •Age \>= 18
排除标准
- •Prior thoracic radiation therapy
- •T2 or T3 tumor greater than 5 cm or T3 tumor based on chest wall involvement
- •Node positive or metastatic disease
- •Tumor location within the zone of the proximal bronchial tree. The proximal bronchial tree is defined as the carina, right and left main bronchi, right and left upper lobe bronchi, bronchus intermedius, right middle lobe bronchus, lingular bronchus, and right and left lower lobe bronchi. The zone of the proximal bronchial tree is defined as a volume 2cm in all directions around the proximal bronchial tree.
- •No other conditions deemed by the PI or associates to make the patient ineligible for protocol investigations, procedures, and high-dose external beam radiotherapy (e.g., unable to lie still and breathe reproducibly)
- •Pregnant or unwilling to use adequate contraception
结局指标
主要结局
Incidence of AE Grade 3 or Higher Toxicity
时间窗: 1year
Count of patients experiencing at least one grade 3 or higher adverse event. The Common Terminology Criteria for Adverse Events (CTCAE) v3.0 is used for assessing the adverse events. High grades AEs are considered worse.
Correlation Between Blood and Serum Markers and Survival and Toxicity
时间窗: 4 years
Overall Survival
时间窗: 5 years
Median overall survival