NCT00346320已完成不适用
A Phase II Study of Accelerated Hypofractionated 3-Dimensional Conformal Radiotherapy (3DCRT) For Inoperable Stage I/II Non-Small Cell Lung Cancer (NSCLC)
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 19
- 主要终点
- Local tumor control rate at 2 years
研究概览
简要总结
RATIONALE: Radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue.
PURPOSE: This phase II trial is studying how well radiation therapy works in treating patients with stage I or stage II non-small cell lung cancer that cannot be removed by surgery.
详细描述
OBJECTIVES:
Primary
- Determine the local tumor control rate at 2 years after accelerated hypofractionated 3-dimensional, conformal radiotherapy in patients with inoperable T1-3 N0 M0 non-small cell lung cancer.
Secondary
- Determine the toxicities of this regimen in these patients.
- Determine the rates of regional and distant disease recurrence in these patients.
- Determine the progression-free and overall survival of patients treated with this regimen.
- Determine the changes in pulmonary function after treatment in these patients.
- Assess the quality of life of patients after treatment.
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 (NSCLC)
- •Stage I or II peripheral disease
- •T1, N0, M0
- •T2 (≤ 5 cm), N0, M0
- •T3 (≤ 5 cm, chest wall primary tumor only), N0, M0
- •No T2-T3 primary tumors > 5 cm or any T1-T3 tumor of the mainstem bronchus involvement
- •No T1-T3 tumor in the lung apex (i.e., tumor in a position that will result in irradiation of the brachial plexus to the prescribed dose)
- •Hilar or mediastinal lymph nodes ≤ 1 cm considered N0
- •Any of the following primary cancer types:
- •Squamous cell carcinoma
- •Adenocarcinoma
- •Large cell carcinoma
- •Bronchioloalveolar cell carcinoma
- •Non-small cell carcinoma not otherwise specified
- •Underlying physiological medical condition that prohibits surgery due to a low probability of tolerating general anesthesia, the operation, the postoperative recovery period, or the removal of adjacent functional lung (i.e., medically inoperable)
- •Cytologic specimens obtained by brushing, washing, or needle aspiration of defined lesion allowed
- •If sputum cytology alone is used for diagnosis, it must be confirmed on a second specimen
- •Must develop a radiotherapy plan that meets the dose-volume constraints for critical organs
- •No ataxia telangiectasia
- •PATIENT CHARACTERISTICS:
- •ECOG performance status 0-2
- •Not pregnant or nursing
- •Able and willing to complete a quality of life questionnaire unless not literate in either English or French (i.e., a translator is required to comprehend the questions and reply)
- •No active systemic, pulmonary, or pericardial infection
- •No previous malignancy except adequately treated nonmelanomatous skin cancer or carcinoma in situ of the cervix.
- •Previous diagnosis of cancer that is free of recurrence and metastases for ≥ 2 years and, in the opinion of the treating physician, does not have a substantial risk of recurrence allowed (including prior lung cancer)
- •PRIOR CONCURRENT THERAPY:
- •No prior radiotherapy to the area of the primary tumor
- •No prior or concurrent chemotherapy or immunotherapy for this tumor
排除标准
- 未提供
研究组 & 干预措施
Radiotherapy
Experimental
3-dimensional conformal radiotherapy, 60 Gy in once daily 4 Gy fractions (Monday to Friday) over 3 weeks
干预措施: 3-dimensional conformal radiation therapy (Radiation)
结局指标
主要结局
Local tumor control rate at 2 years
时间窗: 2 years
Overall tumor control rate will be assessed at 6 years
次要结局
- Toxicity(6 years)
- Disease recurrence rates(6 years)
- Progression-free survival(6 years)
- Overall survival(6 years)
- Quality of life(6 years)
- Changes in pulmonary function(6 years)
研究者
研究点 (19)
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