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| Sponsored by: |
National Taiwan University Hospital |
|---|---|
| Information provided by: | National Taiwan University Hospital |
| ClinicalTrials.gov Identifier: | NCT00155909 |
Purpose
A prospective observational study to evaluate clinical, dosimetrical, functional, and biological factors in predicting radiation pneumonitis.
| Condition |
|---|
|
Radiation Pneumonitis |
| Study Type: | Observational |
| Study Design: | Natural History, Longitudinal, Defined Population, Prospective Study |
| Official Title: | 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 |
| Estimated Enrollment: | 53 |
| Study Start Date: | July 2003 |
| Estimated Study Completion Date: | June 2006 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Chun-Ru Chien, M.D. | 886-2-23123456 ext 2643 | stwo@ha.mc.ntu.edu.tw |
| Contact: Wei-Chu Chie, M.D.and PhD | 886-2-23516478 ext 26 | weichu@episerv.cph.ntu.edu.tw |
| Taiwan | |
| National Taiwan University Hospital | Recruiting |
| Taipei, Taiwan, 100 | |
| Contact: Chun-Ru Chien, MD 886-23123456 ext 2643 stwo@ha.mc.ntu.edu.tw | |
| Contact: Wei Chu Chie, M.D., Ph.D. 886-2-23516478 ext 26 weichu@episerv.cph.ntu.edu.tw | |
| Principal Investigator: Chun-Ru Chien, M.D. | |
| Principal Investigator: | Chun-Ru Chien, M.D. | National Taiwan University Hospital |
More Information
| Study ID Numbers: | 9261700803, NTUH-92N013 |
| Study First Received: | September 9, 2005 |
| Last Updated: | November 22, 2005 |
| ClinicalTrials.gov Identifier: | NCT00155909 History of Changes |
| Health Authority: | Taiwan: Department of Health |
|
Radiation Pneumonitis Radiotherapy Planning, Computer-Assisted |
|
Lung Diseases, Interstitial Respiratory Tract Infections Respiratory Tract Diseases Fibrosis Lung Neoplasms Lung Diseases |
Wounds and Injuries Quality of Life Disorders of Environmental Origin Radiation Pneumonitis Radiation Injuries Pneumonia |
|
Lung Diseases, Interstitial Respiratory Tract Infections Respiratory Tract Diseases Lung Diseases Wounds and Injuries |
Disorders of Environmental Origin Radiation Pneumonitis Radiation Injuries Pneumonia |