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| ID | Type | Description | Link |
|---|---|---|---|
| 00036616 | Other Identifier | Advarra IRB | |
| LCI-LUN-SBRT-002 | Other Identifier | Atrium |
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| Name | Class |
|---|---|
| Atrium Health Levine Cancer Institute | OTHER |
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This is a pilot study designed to to provide data and experience comparing two different techniques of breath hold SBRT treatments. The first technique will include SGRT, but with the assistance of implanted fiducials. Subjects will be treated with a breath hold technique utilizing SGRT, but will also be imaged during treatment with fiducial match. The second technique will utilize SGRT for breath hold treatments without the assistance of implanted fiducials/continuous imaging.
The study's primary objective is estimate the incidence of SBRT and fiducial-related pulmonary toxicities for subjects treated with SBRT who have tumors that move ≥ 1 cm in 3 different cohorts: 1) free breathing with SGRT 2) breath hold utilizing SGRT only; 3) breath hold utilizing SGRT in combination with implanted fiducials. Secondary objectives also include Estimate reliability of gated SBRT treatments utilizing SGRT vs. SGRT with fiducials estimating local control for SBRT in subjects treated in the three different cohorts, estimating overall survival, and evaluating quality of life. A safety objective of estimating acute and long-term grade 2 or higher non-hematologic toxicities attributed to SBRT/fiducial implantation in subjects treated in the three different cohorts will also be explored.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | Freebreathing SBRT with SGRT |
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| Group 2 | Experimental | Breath hold SBRT with SGRT |
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| Group 3 | Experimental | Breath hold SBRT with SGRT in combination with implanted fiducials |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SGRT | Device | Surface Guided Radiation Therapy |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence of SBRT and fiducial-related pulmonary toxicities as assessed by NCI CTCAE v.5.0 | The outcome will be recorded as a binary variable determined for each subject indicating whether or not the subject had at least one grade 2 or higher pulmonary toxicity related to SBRT or implantation of fiducials. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Reliability of gated SBRT treatments utilizing SGRT vs. SGRT with fiducials | This will be recorded as numerical values for each of the shift/rotational directions and the vector composites of the directional shifts at the time of verification imaging. | approx. 2 weeks |
| Local control of treated tumor(s) |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Grade 2 or higher non-hematologic toxicities attributed to SBRT and fiducial implantation | Incidence rates for acute and long-term adverse events of special interest, SAEs, and deaths from the time of initiation of SBRT until 12 months after the last treatment of SBRT will be summarized as counts and proportions. | up to 12 months after the last treatment of SBRT |
Inclusion Criteria
Subject must meet all of the following applicable inclusion criteria to participate in this study:
Exclusion Criteria
Subjects meeting any of the criteria below may not participate in the study:
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| Name | Affiliation | Role |
|---|---|---|
| John Heinzerling, MD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Levine Cancer Institute | Charlotte | North Carolina | 28204 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jul 26, 2022 | Oct 17, 2024 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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The outcome will be measured as the duration of time from enrollment to progression of the subject's treated tumor(s) |
| up to 24 months |
| Overall Survival | This outcome will be measured as the duration of time from the date of enrollment to the study to the date of death from any cause. | approx. 5 years |
| Change from Baseline in MD Anderson Symptom Inventory - Lung Cancer (MDASI-LC) Score | The MDASI-LC Module includes 22 questions to assess the severity of multiple lung cancer-related symptoms and the impact of these symptoms on daily functioning. Scores for each item range from 0 to 10, where 0 indicates no symptoms and 10 indicates worst possible symptoms. | pre-SBRT and 1, 3, 6, and 12 months after the last treatment of SBRT |
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |