Risk Factors of Radiation Pneumonitis
Summary
A prospective observational study to evaluate clinical, dosimetrical, functional, and biological factors in predicting radiation pneumonitis.
Description
We propose a prospective observational study to investigate the combinational effect of radiotherapeutic dosimetric parameters [mean lung dose & percentage of lung volume receiving at least 20Gy (V20)] and biological parameters [interleukin-6(IL6) & transforming growth factor beta (TGFB)] in predicting radiation pneumonitis, fibrosis, and change of QoL among at least fifty-three lung cancer patients. Eligibility included pathological or cytological proven small cell or non small cell lung cancer, thoracic RT planned for more than 30Gy [if fraction size >= 3Gy/fx] or 40Gy [if fraction size < 3 Gy/Fx], ECOG performance status [PS] 0-2, body weight loss [BWL] <=10% in previous 6 months, no prior thoracic RT and signed informed consent prior to study entry. Basic pre-radiotherapy information will be collected, which included BWL, ECOG PS, AJCC stage [I-IV], primary lesion site, history of smoking/coexisting lung disease/dosage of chemotherapy/surgical resection, albumin level, and pulmonary function test of FEV1/VC/DLCO(optional). Computed tomography [CT] of the whole lung in treatment position with reference mark will be done for calculation of V20 and mean lung dose. Blood test of IL6, TGFB by ELISA will be done before and after RT after storage at -80℃. Bronchial-alveolar lavage test of IL6, TGFB by ELISA will be done before and after RT if clinical available. Self-reported questionnaire [EORTC C30 & L13] will be collected before and after RT and in every follow up visits after double-checked by trained assistants. RT must be given by photon energies >=6MV. Radiation pneumonitis and fibrosis will be assessed according to common toxicity criteria 3 [CTC-3] weekly during RT and in every follow up visits. Chi-square test, 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 Design
Observational Model: Defined Population, Observational Model: Natural History, Time Perspective: Longitudinal, Time Perspective: Prospective
Conditions
Radiation Pneumonitis
Location
National Taiwan University Hospital
Taipei
Taiwan
100
Status
Recruiting
Source
National Taiwan University Hospital
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00155909
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Radiation Pneumonitis
Inflammation of the lung due to harmful effects of ionizing or non-ionizing radiation.
Radiation Tolerance
The ability of some cells or tissues to withstand ionizing radiation without serious injury. Tolerance depends on the species, cell type, and physical and chemical variables, including RADIATION-PROTECTIVE AGENTS and RADIATION-SENSITIZING AGENTS.
Radiation-protective Agents
Drugs used to protect against ionizing radiation. They are usually of interest for use in radiation therapy but have been considered for other, e.g. military, purposes.
Health Physics
The science concerned with problems of radiation protection relevant to reducing or preventing radiation exposure, and the effects of ionizing radiation on humans and their environment.
Radiation, Nonionizing
Electromagnetic radiation which does not produce ions in matter through which it passes. Its wavelengths are generally greater than those of far ultraviolet radiation and range through the longest radio waves.
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