Risk Factors of Radiation Pneumonitis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2005 by National Taiwan University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT00155909
First received: September 9, 2005
Last updated: November 22, 2005
Last verified: June 2005
  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: Observational Model: Defined Population
Time Perspective: Longitudinal
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

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Estimated Enrollment: 53
Study Start Date: July 2003
Estimated Study Completion Date: June 2006
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00155909

Contacts
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

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

No publications provided

ClinicalTrials.gov Identifier: NCT00155909     History of Changes
Other Study ID Numbers: 9261700803, NTUH-92N013
Study First Received: September 9, 2005
Last Updated: November 22, 2005
Health Authority: Taiwan: Department of Health

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

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

ClinicalTrials.gov processed this record on October 19, 2014