Prospective Study on Factors Predicting Chemo-Radiotherapy Induced Pulmonary and Esophageal Injury
|ClinicalTrials.gov Identifier: NCT00631839|
Recruitment Status : Unknown
Verified October 2008 by Shanghai Cancer Hospital, China.
Recruitment status was: Active, not recruiting
First Posted : March 10, 2008
Last Update Posted : October 7, 2008
|Condition or disease||Intervention/treatment|
|Thoracic Neoplasms||Radiation: Thoracic 3-D Conformal Radiotherapy|
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 Type :||Observational|
|Actual Enrollment :||140 participants|
|Official Title:||Prospect Study to Evaluate Clinical, Dosimetrical, Functional, Biological and Genetic Factors in Predicting Chemo-Radiotherapy Induced Lung and Esophagus Injury|
|Study Start Date :||January 2002|
|Actual Primary Completion Date :||January 2006|
|Estimated Study Completion Date :||October 2008|
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)
- 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 ]
Biospecimen Retention: Samples With DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|