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Risk Factors of Radiation Pneumonitis

NCT ID: NCT00155909

Last Updated: 2005-11-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

53 participants

Study Classification

OBSERVATIONAL

Study Start Date

2003-07-31

Study Completion Date

2006-06-30

Brief Summary

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A prospective observational study to evaluate clinical, dosimetrical, functional, and biological factors in predicting radiation pneumonitis.

Detailed Description

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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.

Conditions

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Radiation Pneumonitis

Keywords

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Radiation Pneumonitis Radiotherapy Planning, Computer-Assisted

Study Design

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Observational Model Type

DEFINED_POPULATION

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Taiwan University Hospital

OTHER

Sponsor Role lead

Principal Investigators

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Chun-Ru Chien, M.D.

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University Hospital

Locations

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National Taiwan University Hospital

Taipei, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Chun-Ru Chien, M.D.

Role: CONTACT

Phone: 886-2-23123456

Email: [email protected]

Wei-Chu Chie, M.D.and PhD

Role: CONTACT

Phone: 886-2-23516478

Email: [email protected]

Facility Contacts

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Chun-Ru Chien, MD

Role: primary

Wei Chu Chie, M.D., Ph.D.

Role: backup

Other Identifiers

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NTUH-92N013

Identifier Type: -

Identifier Source: secondary_id

9261700803

Identifier Type: -

Identifier Source: org_study_id