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| ID | Type | Description | Link |
|---|---|---|---|
| HM-10395 | Other Identifier | VCU IRB | |
| CDR0000657239 | Registry Identifier | PDQ (Physician Data Query) | |
| NCI-2011-01700 | Registry Identifier | CTRP (Clinical Trials Reporting System) |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This clinical trial studies 4-dimensional (4-D) image-guided radiation therapy treatment planning in patients with stage I-IV non-small cell lung cancer. Computed tomography (CT) scans and treatment-planning systems may help in planning radiation therapy for patients with non-small cell lung cancer. This is not a therapy study. Therefore no direct benefit from participating is expected. However, at the discretion of the treating physician, the information gained from the additional imaging will be used to improve treatment accuracy. No patient outcome data are gathered or analyzed by this study. This study is not a:Phase I, II, or III trial, trial with "blinded" treatment arm, gene or a vaccine trial, or a multi-institutional trial.
OBJECTIVES:
OUTLINE: Patients undergo insertion of ≥ 1 small radio-opaque marker into (or in the vicinity of) the primary lesion or suspect lymph nodes via bronchoscopy. X-rays are performed to document the position of the markers.
Patients undergo 4D CT scan before each radiotherapy session and once a week after a radiotherapy session. Patients also undergo x-ray imaging before and during radiotherapy, optical and internal marker motion recording before and after radiotherapy, and audiovisual feedback during radiotherapy.
Patients undergo image-guided adapted radiotherapy based on these data.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CT Imaging | Experimental | Patients undergo 4-D, 4-dimensional computed tomography, CT imaging prior to radiotherapy sessions and once a week at the end of treatment. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 4-dimensional computed tomography | Procedure | Undergo 4-D CT imaging |
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| Measure | Description | Time Frame |
|---|---|---|
| At least 1 mm reduction in overall systematic error corresponding with ≥ 2 mm CTV-PTV margin reduction | Up to 7 years | |
| At least 5 Gy reduction in mean lung dose | up to 7 years | |
| At least 5% reduction in absolute pneumonitis risk (≥ grade 2) | up to 7 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeffrey F. Williamson, PhD | Massey Cancer Center | Principal Investigator |
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| Label | URL |
|---|---|
| published article | View source |
| published article | View source |
| published article |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| View source |
| This article has been featured in: http://biomedfrontiers.org/cancer-2014-2-4/ | View source |
| published article | View source |
| published article | View source |
| published article | View source |
| published article | View source |
| published article | View source |
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |