Ignite Creation Date:
2024-05-05 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00155909
Status:
UNKNOWN
Last Update Posted:
2005-11-23
First Post:
2005-09-09
Brief Title:
Risk Factors of Radiation Pneumonitis
Sponsor:
National Taiwan University Hospital
Organization:
National Taiwan University Hospital
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2005-06
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A prospective observational study to evaluate clinical dosimetrical functional and biological factors in predicting 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-6IL6 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 3Gyfx or 40Gy if fraction size 3 GyFx 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 smokingcoexisting lung diseasedosage of chemotherapysurgical resection albumin level and pulmonary function test of FEV1VCDLCOoptional 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 parameters can be effective in predicting radiation related sequelae
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NTUH-92N013 | None | None | None |