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Prospective Study on Factors Predicting Chemo-Radiotherapy Induced Pulmonary and Esophageal Injury
This study is ongoing, but not recruiting participants.
Study NCT00631839   Information provided by Shanghai Cancer Hospital,China
First Received: March 2, 2008   Last Updated: October 6, 2008   History of Changes

March 2, 2008
October 6, 2008
January 2002
January 2006   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00631839 on ClinicalTrials.gov Archive Site
 
 
 
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

The purpose of this study is 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
Cohort, Prospective
Thoracic Neoplasms
Radiation: Thoracic 3-D Conformal Radiotherapy
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.
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
140
October 2008
January 2006   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Non-pregnant adults (18<= age <= 75 y/o)
  • Chinese ethnicity
  • Pathological or cytological proven thoracic neoplasms (of note,sputum cytology alone is not acceptable.Cytological specimens obtained by brushing,washing and needle aspiration of a defined lesion are acceptable)
  • Initially treated
  • No distant metastasis
  • ECOG PS 0-2 (Karnofsky>60%)
  • Understand and willing to sign the consent
  • Normal organ and marrow function as defined below:

    • Leukocytes >=3,000/µL
    • Haemoglobin >=9 g/dL (prior to transfusions)
    • Absolute neutrophil count >=1,500/µL
    • Platelets >=100,000/µL
    • Total bilirubin < 1.5 x upper limit of normal
    • AST (SGOT)/ALT (SGPT) ≤2.5 X institutional upper limit of normal
    • Creatinine <=2.5 mg/dl.

Exclusion Criteria:

  • Prior thoracic radiotherapy
  • Distant metastasis
  • Allergic reactions attributed to compounds of similar chemical or biologic composition to platinum-based drugs.
  • Pre-existed non-oncological pulmonary or esophageal disease that may put the patient at high risk of severe toxicities.
  • Other uncontrolled intercurrent illness including, but not limited to, ongoing or active infection and psychiatric illness/social situations that would limit compliance with study requirement
  • pregnancy or lactating
  • Receiving other investigational agents or devices
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT00631839
Fan Min, Associate Professor, Vice Chief of Lung Cancer Center, Fudan University, Shanghai Cancer Hospital, China
FDCA002
Shanghai Cancer Hospital,China
 
Principal Investigator: Min Fan, MD Fudan University Cancer Hospital, Department of Radiation Oncology
Shanghai Cancer Hospital,China
October 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP