NCT00631839

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

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 140 (actual)
• Sponsor: Shanghai Cancer Hospital, China · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Thoracic Neoplasms

Interventions

Type	Name	Description
RADIATION	Thoracic 3-D Conformal Radiotherapy	Thoracic RT tailored for each patient, about 60Gy (NSCLC) or 55Gy (SCLC) with photon energies \>=6MV.

Timeline

• Start date: 2002-01-01
• Primary completion: 2006-01-01
• Completion: 2008-10-01
• First posted: 2008-03-10
• Last updated: 2008-10-07

Locations

1 site across 1 country: China