To Investigate Risk Factors of Radiation Pneumonitis, Fibrosis, and Impairment of Quality of Life by Radiotherapeutic Dosimetric and Biological Parameters for Lung Cancer Patients Receiving Thoracic Radiotherapy
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.
Observational
Observational Model: Defined Population, Observational Model: Natural History, Time Perspective: Longitudinal, Time Perspective: Prospective
Chun-Ru Chien, M.D.
Principal Investigator
National Taiwan University Hospital
Taiwan: Department of Health
9261700803
NCT00155909
July 2003
June 2006
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