Prospect Study 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.
Observational
Observational Model: Cohort, Time Perspective: Prospective
Chemo-Radiotherapy induced pneumonitis,fibrosis and esophagus injury assessed with common toxicity criteria adverse effect version3.0 [CTCAE-3.0]
from the begining of treatment to the end of follow-up
Yes
Min Fan, MD
Principal Investigator
Fudan University Cancer Hospital, Department of Radiation Oncology
China: Ethics Committee
FDCA002
NCT00631839
January 2002
October 2008
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