NCT00551369已完成2 期
A Phase II Trial of Stereotactic Body Radiation Therapy (SBRT) in the Treatment of Patients With Operable Stage I/II Non-Small Cell Lung Cancer
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 19
- 主要终点
- Primary Tumor Control at 2 Years
研究概览
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 near the tumor.
PURPOSE: This phase II trial is studying how well stereotactic body radiation therapy works in treating patients with stage I or stage II non-small cell lung cancer that can be removed by surgery.
详细描述
OBJECTIVES:
Primary
- Determine whether treatment with radiotherapy involving a high biological dose with limited treatment volume (using stereotactic body radiotherapy [SBRT] techniques) achieves acceptable primary tumor control (i.e., ≥ 90% at 2 years) in patients with resectable early-stage non-small cell lung cancer.
Secondary
- Determine whether treatment with radiotherapy involving a high biological dose with limited treatment volume (using SBRT techniques) achieves acceptable treatment-related toxicity.
- Estimate the disease-free survival and the overall survival rate at 2 years.
- Observe patterns of failure in the first 2 years.
- Assess the level of comorbidity burden on morbidity and efficacy.
- Determine if blood markers prior to, during the course of treatment (between the second and the last dose of SBRT), and at the first follow-up after SBRT predict 2-year primary tumor control and predict for grade ≥ 2 treatment-related toxicities
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
- •DISEASE CHARACTERISTICS:
- •Histologically or cytologically confirmed non-small cell lung cancer, including any of the following primary tumor types:
- •Squamous cell carcinoma
- •Adenocarcinoma
- •Large cell carcinoma
- •Large cell neuroendocrine tumor
- •Non-small cell carcinoma not otherwise specified
- •No pure type bronchoalveolar cell carcinoma
- •Stage I or II disease based on 1 of the following combinations of primary tumor, regional nodes, metastasis (TNM) staging:
- •T1, N0, M0
- •T2 (≤ 5 cm), N0, M0
- •T3 (≤ 5 cm), N0, M0 (chest wall primary tumors only)
- •No T2 or T3 primary tumors > 5 cm or T3 primary tumors involving the central chest and structures of the mediastinum
- •No primary tumor of any T-stage within or touching the zone of the proximal bronchial tree, defined as a volume of 2 cm in all directions around the proximal bronchial tree (carina, right and left main bronchi, right and left upper lobe bronchi, intermedius bronchus, right middle lobe bronchus, lingular bronchus, or right and left lower lobe bronchi)
- •Patients with hilar or mediastinal lymph nodes ≤ 1 cm AND no abnormal hilar or mediastinal uptake on positron emission tomography (PET) scan will be considered N0
- •Patients with > 1 cm hilar or mediastinal lymph nodes on CT scan OR abnormal PET scan (including suspicious but nondiagnostic uptake) will still be eligible if directed tissue biopsies of all abnormally identified areas are negative for cancer
- •No direct evidence of regional or distant metastases after appropriate staging studies
- •Considered a reasonable candidate for surgical resection of the primary tumor, according to the following criteria:
- •Primary tumor predicted to be technically resectable with a high likelihood of negative surgical margins (as determined by a qualified thoracic surgeon)
- •Baseline forced expiratory volume (FEV)_1 > 35% predicted
- •Postoperative predicted FEV_1 > 30% predicted
- •Diffusion capacity > 35% predicted
- •No hypoxemia (e.g., partial pressure of arterial oxygen (PaO2) of ≤ 60 mm Hg) and/or hypercapnia (e.g., partial pressure of arterial carbon dioxide (PaCO2) > 50 mm Hg) at baseline
- •No severe pulmonary hypertension
- •No severe cerebral, cardiac, or peripheral vascular disease
- •No severe chronic heart disease
- •Pleural effusion, if present, must be deemed too small to tap under CT scan guidance and must not be evident on chest x-ray
- •Pleural effusion that appears on chest x-ray will be allowed only after thoracotomy or other invasive procedure
- •PATIENT CHARACTERISTICS:
- •Zubrod performance status 0-1
- •Absolute neutrophil count ≥ 1,800/mm³
- •Platelet count ≥ 100,000/mm^3
- •Hemoglobin ≥ 8.0 g/dL (transfusion allowed)
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No synchronous primary or other invasive malignancy within the past 3 years other than nonmelanoma skin cancer or in situ cancer
- •No active systemic, pulmonary, or pericardial infection
- •No weight loss > 5% for any reason within the past 3 months
- •PRIOR CONCURRENT THERAPY:
- •No prior radiotherapy for lung cancer
- •Prior radiotherapy as part of treatment for head and neck cancer, breast cancer, or other non-lung cancer is allowed provided there will not be significant overlap with the stereotactic body radiotherapy fields
- •No prior chemotherapy or surgical resection for this lung cancer
- •No other concurrent local or regional antineoplastic therapy (including standard fractionated radiotherapy, non-approved systemic therapy, and surgery), except at disease progression
排除标准
- 未提供
研究组 & 干预措施
SBRT
Experimental
Stereotactic body radiation therapy (SBRT)
干预措施: SBRT (Radiation)
结局指标
主要结局
Primary Tumor Control at 2 Years
时间窗: From start of treatment to 2 years.
Primary tumor control is defined as the absence of primary tumor failure by 2 years after the start of SBRT. Primary tumor failure was considered as the development of either failure within the SBRT treatment fields (in-field failure) or failure within 1.0 cm of the treatment field (marginal failure). An acceptable tumor control rate at 2 years was considered to be 90% (monthly hazard of 0.00439), and an unacceptable rate was 70% (monthly hazard of 0.01486). A one-sided type 1 error of 0.05 and statistical power of 90% was used. A one-sided Z-test was used to determine if the difference between the logarithm of the observed hazard rate and the logarithm of the hypothesized hazard rate of 0.01486 was statistically significant.
次要结局
- Rate of Treatment-related Grade 3 or 4 Toxicity(From start of treatment to end of follow-up. Analysis can occur at or after time of primary outcome measure analysis.)
- Other Grade 3-5 Adverse Events(From start of treatment to end of follow-up. Analysis can occur at or after time of primary outcome measure analysis.)
- Level of Comorbidity Burden on Morbidity and Efficacy(From start of treatment to end of follow-up.)
- Assessment of Predictive Value of Blood Markers for Primary Tumor Control at 2 Years and Treatment-related Adverse Events ≥ Grade 2(From start of treatment to 2 years.)
- Primary Tumor Failure (PTF), Marginal Failure (MF), Regional Failure (RF), Metastatic Dissemination (MD), Disease-free Survival (DFS), and Overall Survival (OS) at 2 Years(From start of treatment to 2 years.)
研究者
研究点 (19)
Loading locations...
相似试验
已完成
2 期
Stereotactic Body Radiation Therapy and Vertebroplasty in Treating Patients With Localized Spinal MetastasisUnspecified Adult Solid Tumor, Protocol SpecificMetastatic CancerPainNCT00855803University of Texas Southwestern Medical Center35
已完成
1 期
Stereotactic Body Radiation Therapy in Treating Patients With Prostate CancerProstate CancerNCT00547339University of Texas Southwestern Medical Center94
已完成
2 期
Radiation Therapy in Treating Patients With Stage I or Stage II Non-Small Cell Lung CancerLung CancerNCT00843726Roswell Park Cancer Institute98
已完成
2 期
Stereotactic Body Radiation Therapy in Treating Patients With Inoperable Stage I or Stage II Non-Small Cell Lung CancerLung CancerNCT00087438Radiation Therapy Oncology Group59
撤回
1 期
Stereotactic Body Radiation Therapy in Treating Patients With Stage I or Stage II Non-Small Cell Lung CancerLung CancerNCT00471835Wake Forest University Health Sciences