Prospective Study on Factors Predicting Chemo-Radiotherapy Induced Pulmonary and Esophageal Injury
Recruitment status was Active, not recruiting
The purpose of this study is to evaluate clinical, dosimetrical, functional, biological and genetic factors in predicting chemo-radiotherapy induced lung and esophagus injury.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Prospect Study to Evaluate Clinical, Dosimetrical, Functional, Biological and Genetic Factors in Predicting Chemo-Radiotherapy Induced Lung and Esophagus Injury|
- Chemo-Radiotherapy induced pneumonitis,fibrosis and esophagus injury assessed with common toxicity criteria adverse effect version3.0 [CTCAE-3.0] [ Time Frame: from the begining of treatment to the end of follow-up ] [ Designated as safety issue: Yes ]
Biospecimen Retention: Samples With DNA
Patients' blood samples will be retained for the purpose of cytokine and MnSOD assay and DNA detection. The samples will be left till the study ends. Paitents will have their vein blood drawn from left arm 6am every Monday during RT. All above is stated in informed consent form.
|Study Start Date:||January 2002|
|Estimated Study Completion Date:||October 2008|
|Primary Completion Date:||January 2006 (Final data collection date for primary outcome measure)|
There is only one group in this study. The patients of this group will go through procedures as follow: basic pre-treatment information collected,treatment include platinum-based chemotherapy and 3-D conformal radiotherapy, blood test during RT 6am every Monday and follow-up visits with treatment-induced injury assessed.
Radiation: Thoracic 3-D Conformal Radiotherapy
Thoracic RT tailored for each patient, about 60Gy (NSCLC) or 55Gy (SCLC) with photon energies >=6MV.
Other Name: Thoracic Radiotherapy(TRT)
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00631839
|Fudan University, Cancer Hospital, Department of Radiation Oncology|
|Shanghai, China, 200032|
|Principal Investigator:||Min Fan, MD||Fudan University Cancer Hospital, Department of Radiation Oncology|