Radiation Dose Escalation For Non-Small Cell Lung Cancer Using Hypofractionated 3-Dimensional Conformal Radiation Therapy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Acute radio-induced toxicity as assessed by the RTOG/EORTC acute toxicity grading system weekly during radiotherapy
研究概览
简要总结
RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to the tumor over a shorter period of time may kill more tumor cells and cause less damage to normal tissue.
PURPOSE: This phase II trial is studying the side effects of hypofractionated 3-dimensional radiation therapy and to see how well it works in treating patients with newly diagnosed stage I, stage II, or stage III non-small cell lung cancer.
详细描述
OBJECTIVES:
Primary
- To evaluate the acute and long-term radio-induced toxicity (any organ) of hypofractionated 3-dimensional conformal radiotherapy in patients with newly diagnosed stage I-III non-small cell lung cancer.
Secondary
- To assess the radiological tumor response rate at 3 months after completion of radiotherapy.
- To assess the actuarial freedom from thoracic progression rate.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 120 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically or cytologically confirmed newly diagnosed non-small cell lung cancer meeting 1 of the following stage criteria:
- •Stage I or II disease
- •Medically inoperable or patient refused surgery
- •Stage IIIA or IIIB disease (no pleural effusions)
- •Radiation dose parameters must satisfy the required study dose-volume constraints
- •PATIENT CHARACTERISTICS:
- •Karnofsky performance status 70-100%
- •Weight loss ≤ 10% within 3 months before diagnosis
- •No other malignancy within the past 5 years, except nonmelanoma skin cancer
- •No clinically significant cardiovascular disease (e.g., hypertension [blood pressure > 150/100 mm Hg], myocardial infarction or stroke within the past 6 months, or unstable angina)
- •PRIOR CONCURRENT THERAPY:
- •No concurrent chemotherapy
排除标准
- 未提供
研究组 & 干预措施
Group 1
Patients undergo hypofractionated 3-dimensional conformal radiotherapy 5 days a week for 24 fractions (total of 72 Gy).
干预措施: hypofractionated radiation therapy (Radiation)
Group 2
Patients undergo hypofractionated 3-dimensional conformal radiotherapy 5 days a week for 22 fractions (total of 66 Gy).
干预措施: hypofractionated radiation therapy (Radiation)
Group 3
Patients undergo hypofractionated 3-dimensional conformal radiotherapy 5 days a week for 20 fractions (total of 60 Gy).
干预措施: hypofractionated radiation therapy (Radiation)
结局指标
主要结局
Acute radio-induced toxicity as assessed by the RTOG/EORTC acute toxicity grading system weekly during radiotherapy
时间窗: weekly during radiotherapy
Long-term radio-induced toxicity as assessed by the long-term RTOG/EORTC and SWOG (lung) grading system every 3 months for 2 years and then every 6 months thereafter
时间窗: every 3 months for 2 years and then every 6 months thereafter
次要结局
- Tumor response rate (according to WHO response criteria) as assessed by CT scan at 3 months after completion of radiotherapy(at 3 months after completion of radiotherapy)
- Actuarial freedom from thoracic progression rate(ongoing)