A Phase I/II Dose Escalation Study Using Induction Chemotherapy and Intensity-Modulated Radiation Therapy Guided by Combined CT and PET Imaging for Patients With Non-Small Cell Lung Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- safety and adverse effects
研究概览
简要总结
Lung cancer is the leading cause of cancer-related mortality in the United States (US) and Canada. Because of the high incidence and mortality of this disease, small improvements in the management of this disease translates into large numbers of patients having improved outcomes after treatment. Radiation therapy is widely used to treat patients with lung cancer. However, the radiation dose to the tumor has been limited by the proximity of normal structures to the tumor, such as the lung, the spinal cord and the esophagus. The normal structures must not be exposed to excessive radiation doses. A new technique, called intensity-modulated radiotherapy delivers radiation to tumors such that the normal structures around the tumor are exposed to less radiation than previously achievable. This technique is already used to treat head and neck cancers. This study will use this technique to deliver more intensified radiation to the lung tumor after the patient receives two cycles of chemotherapy. A new imaging technique, called positron emission tomography (PET), has been found to be more sensitive and specific at detecting the extent of the tumor in the lung than the older imaging technique of computed tomography (CT). This study will use both the PET and CT to target the radiation beams. Following treatment, the patients will be followed up to assess the side effects of normal tissues and response of the tumor to the treatment.
详细描述
Hypothesis and Objectives: The hypothesis that respiratory gated IMRT can escalate safely radiation doses for NSCLC with induction chemotherapy will be tested. The intent of the study is to determine the maximum tolerable dose of radiotherapy for NSCLC, using a novel treatment planning technique with accelerated fractionation, given with state-of-the-art imaging guidance.
Primary Objective:
- To establish the maximum tolerated dose of radiotherapy by assessing treatment toxicity according to the acute RTOG grading scale.
Secondary Objectives:
- To evaluate the treatment toxicity of the combination regimen according to the chronic RTOG grading scale;
- Quality of Life: to be assessed using the EORTC QLQ-C30 and LC13;
- To determine progression-free survival with this regimen;
- To identify partial organ tolerance doses for lung, esophagus and heart.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Stage I-III
- •Unresectable non-small cell lung cancer (NSCLC)
- •EEV1 equal to or greater than 1.0L
排除标准
- •Positive supraclavicular noce (N2) or malignant pleural effusion
结局指标
主要结局
safety and adverse effects
次要结局
- efficacy and survival
