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Risk Factors of Radiation Pneumonitis

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ClinicalTrials.gov Identifier: NCT00155909
Recruitment Status : Unknown
Verified June 2005 by National Taiwan University Hospital.
Recruitment status was:  Recruiting
First Posted : September 12, 2005
Last Update Posted : November 23, 2005
Information provided by:

Study Description
Brief Summary:
A prospective observational study to evaluate clinical, dosimetrical, functional, and biological factors in predicting radiation pneumonitis.

Condition or disease
Radiation Pneumonitis

Detailed 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

Study Type : Observational
Estimated Enrollment : 53 participants
Observational Model: Defined Population
Observational Model: Natural History
Time Perspective: Longitudinal
Time Perspective: Prospective
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
Study Start Date : July 2003
Estimated Study Completion Date : June 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia
U.S. FDA Resources

Groups and Cohorts

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Non-pregnant adults (age >=20 y/o)
  • 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 PS 0-2
  • Body weight loss <=10% in previous 6 months

Exclusion Criteria:

  • prior thoracic RT
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00155909

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

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.         
Sponsors and Collaborators
National Taiwan University Hospital
Principal Investigator: Chun-Ru Chien, M.D. National Taiwan University Hospital
More Information

ClinicalTrials.gov Identifier: NCT00155909     History of Changes
Other Study ID Numbers: 9261700803
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: November 23, 2005
Last Verified: June 2005

Keywords provided by National Taiwan University Hospital:
Radiation Pneumonitis
Radiotherapy Planning, Computer-Assisted

Additional relevant MeSH terms:
Radiation Pneumonitis
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Lung Diseases, Interstitial
Lung Injury
Radiation Injuries
Wounds and Injuries