Phase II Trial of Consolidative Thoracic Radiotherapy for Extensive Stage Small Cell Lung Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- local control
研究概览
简要总结
The majority of patients with small cell lung cancer have incurable extensive stage disease. The usual initial treatment for this condition is chemotherapy which produces responses in about 50-80% of patients. Despite this, the cancer usually returns. Once common body region where it re-grows is in the chest, which can cause symptoms such as shortness of breath, cough, difficulty swallowing, pain and bleeding. These symptoms can worsen a patient's quality of life and in some situation be life-threatening. In this study , we propose to give patients who have extensive stage small cell lung cancer which responds to chemotherapy radiotherapy treatments to the chest. By giving this type of radiation before the cancer has a chance to re-grow, we hope to control the disease within the chest and prevent future symptoms that it may cause if the cancer were to re-grow in the chest. Patients treated on the protocol will be checked regularly for disease control, quality of life and radiation side effects, if any.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
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
- •Histologic or cytologic confirmation of small cell lung cancer
- •extensive stage disease
- •adequate pulmonary function tests (FEV-1>1.0, DLCO>50%)
- •patients of childbearing potential must practice adequate contraception
- •age ≧ 18 years
- •Karnofsky performance status ≧ 70
- •documented objective response to initial chemotherapy
- •signed study-specific informed consent form
排除标准
- •complete or subtotal tumor resection
- •non-small cell histology
- •prior or concurrent malignancy except non-melanoma skin cancer unless disease-free for at least 5 years
- •prior chest or neck RT
- •inadequate pulmonary function tests (FEV-1<1.0 OR DLCO<50%)
结局指标
主要结局
local control
时间窗: we anticipate completing accrual to the study in 12 months with most local failure events occuring within 2 years of treatment
次要结局
- patient quality of life(1-2 years after study treatment)
- radiotherapy toxicities(1-2 years after study treatment)
- overall survival(1-2 years after study treatment)