Spots Global Cancer Trial Database for Prospective Study on Factors Predicting Chemo-Radiotherapy Induced Pulmonary and Esophageal Injury

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Trial Identification

Brief Title: Prospective Study on Factors Predicting Chemo-Radiotherapy Induced Pulmonary and Esophageal Injury

Official Title: Prospect Study to Evaluate Clinical, Dosimetrical, Functional, Biological and Genetic Factors in Predicting Chemo-Radiotherapy Induced Lung and Esophagus Injury

Study ID: NCT00631839

Conditions

Thoracic Neoplasms

Interventions

Thoracic 3-D Conformal Radiotherapy

Study Description

Brief 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.

Detailed Description: 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.