A Randomized Phase III Study of Sublobar Resection (+/- Brachytherapy) Versus Stereotactic Body Radiation Therapy in High Risk Patients With Stage I Non-Small Cell Lung Cancer (NSCLC)
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 13
- 试验地点
- 53
- 主要终点
- 3-year Overall Survival (OS) Rate
研究概览
简要总结
RATIONALE: Surgery with or without internal radiation therapy may be an effective treatment for non-small cell lung cancer. Internal radiation uses radioactive material placed directly into or near a tumor to kill tumor cells. 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 whether stereotactic body radiation therapy is more effective than surgery with or without internal radiation therapy in treating non-small cell lung cancer.
PURPOSE: This randomized phase III trial is studying how well surgery with or without internal radiation therapy works compared with stereotactic body radiation therapy in treating patients with high-risk stage IA or stage IB non-small cell lung cancer.
详细描述
OBJECTIVES:
Primary
- To ascertain whether patients treated by stereotactic body radiation therapy (SBRT) have a 3-year overall survival (OS) rate that is no more than 10% less than patients treated with sublobar resection (SR).
Secondary
- To compare loco-regional recurrence-free survival between study arms.
- To compare disease-free survival between study arms.
- To compare grade 3 or higher specific adverse event profiles between study arms at 1, 3, 6, and 12 months post-therapy.
- To compare pulmonary function between patients treated with SBRT and patients treated with SR.
- To compare the adverse events and pulmonary function tests (PFTs) in each arm for patients with low or high Charlson comorbidity index scores, including a test interaction between Charlson comorbidity index scores (low vs high) and treatment arm.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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
- •DISEASE CHARACTERISTICS:
- •Lung nodule suspicious for non-small cell lung cancer (NSCLC)
- •Biopsy confirmation is strongly recommended but not required; if biopsy is attempted and non-diagnostic, if the patient refuses biopsy, or if the risk of biopsy is considered too high, patients may be enrolled if the mass is suspicious for NSCLC based on two or more of the following criteria:
- •Positive smoking history
- •Absence of benign calcifications within suspicious nodule
- •Activity on PET greater than normal tissue
- •Evidence of growth compared to previous imaging
- •Presence of spiculation
- •Tumor ≤ 4 cm maximum diameter, clinical stage IA or selected IB (i.e., with visceral pleural involvement) by PET/CT scan of the chest and upper abdomen performed within 60 days prior to registration
- •All clinically suspicious mediastinal N1, N2, or N3 lymph nodes (> 1 cm short-axis dimension on CT scan and/or positive on PET scan) confirmed negative for involvement with NSCLC by one of the following methods: mediastinoscopy, anterior mediastinotomy, endoscopic and/or endobronchial ultrasonography (EUS/EBUS)-guided needle aspiration, CT-guided, or video-assisted thoracoscopic or open lymph node biopsy
- •Tumor verified by a thoracic surgeon to be in a location that will permit sublobar resection
- •Tumor located peripherally within the lung, defined as not touching any surface within 2 cm of the proximal bronchial tree in all directions
- •Patients with non-peripheral (central) tumors are NOT eligible
- •No evidence of distant metastases
- •PATIENT CHARACTERISTICS:
- •ECOG performance status (PS) 0, 1, or 2
- •Patient at high-risk for surgery by meeting a minimum of one major criteria or two minor criteria as described below:
- •Major criteria
- •FEV1 ≤ 50% predicted
- •DLCO ≤ 50% predicted
- •Minor criteria
- •Age ≥ 75 years
- •FEV1 51-60% predicted
- •DLCO 51-60% predicted
- •Pulmonary hypertension (defined as 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 of 40% or less)
- •Resting or exercise arterial pO2 ≤ 55 mm Hg or SpO2 ≤ 88%
- •pCO2 > 45 mm Hg
- •Modified Medical Research Council (MMRC) Dyspnea Scale ≥ 3
- •Not pregnant or nursing
- •Negative urine or serum pregnancy test
- •Fertile patients must use effective contraception
- •No prior invasive malignancy, unless disease-free for ≥ 3 years prior to registration (except non-melanoma skin cancer, in-situ cancers).
- •PRIOR CONCURRENT THERAPY:
- •No prior intra-thoracic radiotherapy
- •Prior radiotherapy as part of treatment for head and neck, breast, or other non-thoracic cancer is permitted
- •Prior chemotherapy or surgical resection for the lung cancer being treated on this protocol is NOT permitted
排除标准
- 未提供
研究组 & 干预措施
Arm I (SR+Brachytherapy)
Patients undergo sublobar resection comprising either a wedge resection or anatomical segmentectomy with or without intraoperative brachytherapy comprising an iodine I 125 implant at the resection margin.
干预措施: iodine I 125 (Radiation)
Arm I (SR+Brachytherapy)
Patients undergo sublobar resection comprising either a wedge resection or anatomical segmentectomy with or without intraoperative brachytherapy comprising an iodine I 125 implant at the resection margin.
干预措施: therapeutic conventional surgery (Procedure)
Arm II (SBRT)
Patients undergo 3 fractions of stereotactic body radiation therapy at 2-8 days apart.
干预措施: stereotactic body radiation therapy (Radiation)
结局指标
主要结局
3-year Overall Survival (OS) Rate
时间窗: Up to 3 years post-randomization
Overall survival is defined as the time from randomization until death from any cause.
次要结局
- Loco-regional Recurrence-free Survival(Up to 5 years post-randomization)
- Adverse Event Profiles at 12 Months Post-therapy(12 months post-therapy)
- Disease-free Survival(Up to 5 years post-randomization)
- Adverse Event Profiles at 1 Month Post-therapy(1 month post-therapy)
- Adverse Event Profiles at 3 Months Post-therapy(3 months post-therapy)
- Pulmonary Function Test Values(Up to 12 months post-therapy)