- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00155909
Risk Factors of Radiation Pneumonitis
November 22, 2005 updated by: National Taiwan University Hospital
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
A prospective observational study to evaluate clinical, dosimetrical, functional, and biological factors in predicting radiation pneumonitis.
Study Overview
Status
Unknown
Conditions
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 Type
Observational
Enrollment
53
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Chun-Ru Chien, M.D.
- Phone Number: 2643 886-2-23123456
- Email: stwo@ha.mc.ntu.edu.tw
Study Contact Backup
- Name: Wei-Chu Chie, M.D.and PhD
- Phone Number: 26 886-2-23516478
- Email: weichu@episerv.cph.ntu.edu.tw
Study Locations
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Taipei, Taiwan, 100
- Recruiting
- National Taiwan University Hospital
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Contact:
- Chun-Ru Chien, MD
- Phone Number: 2643 886-23123456
- Email: stwo@ha.mc.ntu.edu.tw
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Contact:
- Wei Chu Chie, M.D., Ph.D.
- Phone Number: 26 886-2-23516478
- Email: weichu@episerv.cph.ntu.edu.tw
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Principal Investigator:
- Chun-Ru Chien, M.D.
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Defined Population
- Time Perspectives: Prospective
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Chun-Ru Chien, M.D., National Taiwan University Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2003
Study Completion
June 1, 2006
Study Registration Dates
First Submitted
September 9, 2005
First Submitted That Met QC Criteria
September 9, 2005
First Posted (Estimate)
September 12, 2005
Study Record Updates
Last Update Posted (Estimate)
November 23, 2005
Last Update Submitted That Met QC Criteria
November 22, 2005
Last Verified
June 1, 2005
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 9261700803
- NTUH-92N013
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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