Intensity-modulated Hyperfractionated Radiotherapy Boost to Residual Metabolic Disease Following Standard Chemoradiotherapy for Locally Advanced Non-small Cell Lung Cancer
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- overall survival rate
研究概览
简要总结
To assess the efficacy and feasibility of high-dose intensity-modulated radiotherapy with concurrent weekly paclitaxel and cisplatin for patients with locoregionally advanced non-small lung cancer.
详细描述
Local failure remains high in patients with locoregionally advanced non-small lung cancer. Given that a biological equivalent dose (BED)more than 100 Gy yields approximately a local control rate of 90% in early-stage non-small lung cancer, this BED or ever higher is logically required to control local disease for locally advanced non-small lung cancer. However, dose escalation is limited by radiation-related toxicity. Use of hyperfractionated radiation Therapy boost to residual metabolic disease as defined by positron emission tomography and computed tomography (PET/CT) immediately after standard chemoradiotherapy (SCRT) using image-guided (IG) IMRT could potentially improve local control and perhaps survival
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must have FDG-avid and histologically or cytologically proven non-small cell lung cancer.
- •Eastern Cooperative Oncology Group （ECOG） performance status 0 to
- •Stage III ( American Joint Committee on Cancer AJCC, 7th ed.).
- •No prior radiation to the thorax that would overlap with the current treatment field.
- •Adequate bone marrow, renal and hepatic functions as assessed by the following: Hemoglobin >/= 10.0 g/dl, Platelet count >/= 1 00,000/ mm^3,absolute granulocyte count (AGC) ≥2 × 10^9 cells/L,bilirubin and Aspartate transaminase ≤1.5 ×upper limit of normal (ULN), Creatinine </ =1 .5 times ULN.
- •A signed informed consent must be obtained prior to therapy.
- •Induction chemotherapy is allowed.
- •Life expectancy more than 3 months
排除标准
- •Patients with any component of small cell lung carcinoma are excluded from this study.
- •Patients with evidence of a malignant pleural or pericardial effusion are excluded.
- •Prior radiotherapy that would overlap the radiation fields.
- •Uncontrolled concurrent illness including, but not limited to: Chronic Obstructive Pulmonary Disease(COPD) exacerbation or other respiratory illness, serious uncontrolled infection, symptomatic congestive heart failure (CHF),unstable angina pectoris, uncontrolled hypertension,or psychiatric illness/social situations that would limit compliance with the study requirements.
- •Known hypersensitivity to paclitaxel.
- •Any other condition or circumstance that would, in the opinion of the Investigator, make the patient unsuitable for participation in the study.
- •Conditions precluding medical follow-up and protocol compliance
结局指标
主要结局
overall survival rate
时间窗: 2 year
survival time was measured from the date of study enrollment to the date of death or last follow-up
次要结局
- toxicities(2 year)
研究者
Chen tingfeng
director, department of radiation
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine