prospective study on factors predicting chemo-radiotherapy induced pulmonary and esophageal injury

Conditions: Thoracic Neoplasms

Summary: the purpose of this study is to evaluate clinical, dosimetrical, functional, biological and genetic factors in predicting chemo-radiotherapy induced lung and esophagus injury.

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.

Eligibility criteria:
inclusion criteria: * 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. exclusion criteria: * 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

Keywords: thoracic neoplasms platinum-based chemotherapy 3-d conformal radiotherapy chemo-radiotherapy induced lung injury chemo-radiotherapy induced esophagus injury