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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | March 2, 2008 | ||||
| Last Updated Date | October 6, 2008 | ||||
| Start Date ICMJE | January 2002 | ||||
| Primary Completion Date | January 2006 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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 ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00631839 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Prospective Study on Factors Predicting Chemo-Radiotherapy Induced Pulmonary and Esophageal Injury | ||||
| Official Title ICMJE | Prospect Study to Evaluate Clinical, Dosimetrical, Functional, Biological and Genetic Factors in Predicting Chemo-Radiotherapy Induced Lung and Esophagus Injury | ||||
| Brief 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. |
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| 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. |
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| Study Phase | |||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Cohort, Prospective | ||||
| Condition ICMJE | Thoracic Neoplasms | ||||
| Intervention ICMJE | Radiation: Thoracic 3-D Conformal Radiotherapy | ||||
| Study Arms / Comparison Groups | 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. | ||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Enrollment ICMJE | 140 | ||||
| Estimated Completion Date | October 2008 | ||||
| Primary Completion Date | January 2006 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 75 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | China | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00631839 | ||||
| Responsible Party | Fan Min, Associate Professor, Vice Chief of Lung Cancer Center, Fudan University, Shanghai Cancer Hospital, China | ||||
| Study ID Numbers ICMJE | FDCA002 | ||||
| Study Sponsor ICMJE | Shanghai Cancer Hospital,China | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Shanghai Cancer Hospital,China | ||||
| Verification Date | October 2008 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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