Prospect Study to Evaluate Clinical, Dosimetrical, Functional, Biological and Genetic Factors in Predicting Chemo-Radiotherapy Induced Lung and Esophagus Injury
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Chemo-Radiotherapy induced pneumonitis,fibrosis and esophagus injury assessed with common toxicity criteria adverse effect version3.0 [CTCAE-3.0]
研究概览
简要总结
The purpose of this study is to evaluate clinical, dosimetrical, functional, biological and genetic factors in predicting chemo-radiotherapy induced lung and esophagus injury.
详细描述
We propose a prospective study to investigate the combinational effect of radiotherapeutic dosimetric parameters [mean lung dose and percentage of lung volume receiving at least XGy (Vx)] and biological parameters [interleukin-1α(IL1α),interleukin-1β(IL1β),interleukin-6(IL6),interleukin-7(IL7),transforming growth factor beta (TGFB)] and manganese superoxide dismutase(MnSOD) in predicting radiation pneumonitis, fibrosis, and radiation esophageal injury. Eligibility included pathological or cytological proven thoracic cancer,ECOG performance status [PS] 0-2, no prior thoracic RT or chemotherapy,no distant metastasis and signed informed consent prior to study entry.
Basic pre-treatment information will be collected, which included ECOG PS, UICC/AJCC stage,primary lesion site, history of smoking/coexisting lung disease/surgical resection, and pulmonary function test of FEV1/VC/DLCO. Computed tomography [CT] of the whole lung in treatment position. Blood test of IL1α,IL1β,IL6,IL7,TGFB and MnSOD by ELISA will be done before and weekly during RT. RT must be given by photon energies >=6MV. Radiation lung and esophageal injury will be assessed according to common toxicity criteria adverse effect version3.0 [CTCAE-3.0] during RT and in every follow up visits. Genomic DNA is obtained from the blood drawn during RT. Chi-square test, T test, analysis of variance, logistic regression, and proportional hazard ratio method will be used to investigate whether the parameter(s) can be effective in predicting radiation related sequelae.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Non-pregnant adults (18<= age <= 75 y/o)
- •Chinese ethnicity
- •Pathological or cytological proven thoracic neoplasms (of note,sputum cytology alone is not acceptable.Cytological specimens obtained by brushing,washing and needle aspiration of a defined lesion are acceptable)
- •Initially treated
- •No distant metastasis
- •ECOG PS 0-2 (Karnofsky>60%)
- •Understand and willing to sign the consent
- •Normal organ and marrow function as defined below:
- •Leukocytes >=3,000/µL
- •Haemoglobin >=9 g/dL (prior to transfusions)
- •Absolute neutrophil count >=1,500/µL
- •Platelets >=100,000/µL
- •Total bilirubin < 1.5 x upper limit of normal
- •AST (SGOT)/ALT (SGPT) ≤2.5 X institutional upper limit of normal
- •Creatinine <=2.5 mg/dl.
排除标准
- •Prior thoracic radiotherapy
- •Distant metastasis
- •Allergic reactions attributed to compounds of similar chemical or biologic composition to platinum-based drugs.
- •Pre-existed non-oncological pulmonary or esophageal disease that may put the patient at high risk of severe toxicities.
- •Other uncontrolled intercurrent illness including, but not limited to, ongoing or active infection and psychiatric illness/social situations that would limit compliance with study requirement
- •pregnancy or lactating
- •Receiving other investigational agents or devices
结局指标
主要结局
Chemo-Radiotherapy induced pneumonitis,fibrosis and esophagus injury assessed with common toxicity criteria adverse effect version3.0 [CTCAE-3.0]
时间窗: from the begining of treatment to the end of follow-up
次要结局
未报告次要终点