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

Thoracic Neoplasms Clinical Trial

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

Status Active, not recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Thoracic Neoplasms

• NCT number: NCT00631839
• Study type: Observational
• Source: Shanghai Cancer Hospital, China
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 2002
• Completion date: October 2008