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| ID | Type | Description | Link |
|---|---|---|---|
| WFBCCC 01221 | Other Identifier | Wake Forest Baptist Comprehensive Cancer Center |
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The purpose of this research study is to see if adding an "extra" check by formal radiology review is possible without disrupting the normal processes that take place to develop and prepare a safe radiation treatment plan for patients.
Primary Objectives: The primary objective will be to demonstrate the feasibility of radiology completing real time review of radiation oncology treatment plans within 4 business days of the date of CT simulation (defined as day = 0). If 50% of plans can be reviewed by any member of the thoracic radiology team (Includes radiology PI and co-investigators) and feedback is submitted to radiation oncology with Appendix D within 4 business days of the date of simulation, then we will consider this workflow feasible.
Secondary Objectives:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Radiology Treatment Planning/Review | Other | After patient consultation and enrollment, the patient will undergo routine CT simulation to initiate the radiation treatment planning process. The treating physician will contour the gross tumor volume (GTV) including the involved primary lung tumor and/or the involved lymph nodes. If the initial radiology review reflects concern for inadequate target volume delineation, the case will be flagged for multidisciplinary discussion between the radiation oncologist and radiologist. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CT Simulation | Procedure | Patient will undergo routine CT simulation to initiate radiation treatment planning process. For the purposes of this study, the day of CT simulation "mapping scan" will be counted as day 0. After the patient completes the CT simulation scan, the CT images and plan/structure files will be sent to the treatment planning system. The treating physician will contour the gross tumor volume (GTV) including the involved primary lung tumor and/or the involved lymph nodes. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Completed Radiation Treatment Plans Reviewed | Completed initial radiology review within 4 business days after the date of CT simulation will be calculated using summary statistics including count (frequency) using a 95% confidence interval. | Within four days after CT simulation |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients Whose Radiation Treatment Plans Changed | Will be calculated using summary statistics including count (frequency) and corresponding 95% confidence intervals. | 4 days |
| Changes in Volumes After Radiation Treatment Changes - Gross Tumor Volume |
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Inclusion Criteria:
Exclusion Criteria: Not being treated with radiation, or being treated with non-curative intent per the treating radiation oncologist.
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| Name | Affiliation | Role |
|---|---|---|
| Michael Farris, MD | Wake Forest Baptist Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| High Point Medical Center | High Point | North Carolina | 27262 | United States | ||
| Wake Forest Baptist Health - Lexington |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36759296 | Derived | Farris MK, Razavian NB, Hughes RT, Ververs JD, Snavely AC, Leyrer CM, Tye KE, Allen LF, Pacholke HD, Weaver KE, Bunch PM, Chan MD, Clark H, Puthoff G, Farris JC, Steber CR, Wentworth S, Levine BJ, Nightingale CL, Ponnatapura J. Bridging the Communication Gaps: A Prospective Single-Arm Pilot Study Testing the Feasibility of Interdisciplinary Radiotherapy Planning in Locally Advanced Lung Cancer. Acad Radiol. 2023 Nov;30(11):2566-2573. doi: 10.1016/j.acra.2023.01.019. Epub 2023 Feb 8. |
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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 | Sep 21, 2021 | Jun 30, 2022 | 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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|
For patients whose radiation therapy plans are changed, the change in volume (in centimeters cubed) of gross tumor volume (GVT) before and after the recommended change is made will be summarized using mean and standard deviation and median range. |
| 4 days |
| Changes in Volumes After Radiation Treatment Changes - Clinical Tumor Volume | For patients whose radiation therapy plans are changed, the change in volume (in centimeters cubed) of clinical target volume (CTV) before and after the recommended change is made will be summarized using mean and standard deviation and median range. | 4 days |
| Changes in Volumes After Radiation Treatment Changes - Planning Tumor Volume | For patients whose radiation therapy plans are changed, the change in volume (in centimeters cubed) of planning target volume (PTV) before and after the recommended change is made will be summarized using mean and standard deviation and median range. | 4 days |
| Changes in Dose Delivered After Radiation Treatment Changes to the Lungs | For patients whose RT plans are changed, the change in the dose delivered to the lungs (V5, V10, V20) will be summarized using mean (standard deviation) and median (range). | 4 days |
| Changes in Dose Delivered After Radiation Treatment Changes to the Esophagus | For patients whose RT plans are changed, the change in the dose delivered to the and esophagus (mean, V60) will be summarized using mean (standard deviation) and median (range). | 4 days |
| Number of Patients Who's Treatment Starts are Delayed | For patients whose radiation therapy plans are changed: the proportion of treatment starts that are delayed from the initial planned start day due to the application of recommended changes will be calculated using summary statistics including count (frequency) | 4 days |
| Number of Changes Recommended by the Radiation Therapy Quality Assurance Conference (RT QAC) | Will be calculated using summary statistics including count (frequency) and will also be captured in full qualitative form. | 4 days |
| Number of Patients with Acute Esophagitis | Will be reported using descriptive statistics (mean, median, standard deviations, proportions, and 95% confidence intervals) and will also be compared to the historical institutional control incidence and severity of esophagitis using 1-sample z-tests and 1-sample tests of proportions (considering historical control as "population parameter.") | 4 weeks after completion of therapy |
| Cancer Response | Will be assessed by radiology on imaging and will be summarized using frequencies and proportions. Proportion of those with positive response will be compared to historical institution control using a 1-sample test of proportions (considering historical control as "population parameter."). | 1 month after completion of therapy |
| Lexington |
| North Carolina |
| 27292 |
| United States |
| Iredell Memorial Hospital | Statesville | North Carolina | 28677 | United States |
| Wake Forest Baptist Health Sciences | Winston-Salem | North Carolina | 27157 | United States |
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |