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| ID | Type | Description | Link |
|---|---|---|---|
| R01CA258681 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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The development of stereotactic body radiation therapy (SBRT) for the treatment of stage I non-small cell lung cancer (NSCLC) has inspired a close partnership between thoracic surgery and radiation oncology. In this study, patients with stage I NSCLC will be screened prior to treatment and will be consented after their treatment plan has been determined. Prospectively collected patient-reported outcomes (PROs) will be collected for 3 years or for the duration of the study (whichever is shorter), as will outcomes data.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Surgery |
| ||
| Stereotactic body radiotherapy (SBRT) |
|
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| Measure | Description | Time Frame |
|---|---|---|
| Disease-free survival (DFS) | DFS is defined as time from the date of treatment to date of disease recurrence or death, whichever occurs earlier. | Through 36 months post-treatment (estimated to be 36 months and 1 week) |
| Change in patient-reported outcomes as measured by the PROMIS Bank survey |
| From baseline through 36 months post-treatment (estimated to be 36 months and 1 week) |
| Measure | Description | Time Frame |
|---|---|---|
| Cancer-specific survival (CSS) | Cancer-specific survival (CSS) is defined as time from the date of treatment to date of cancer-related death. The alive patients without any signs or symptoms of that cancer are censored at the last follow-up. | Through 36 months post-treatment (estimated to be 36 months and 1 week) |
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Inclusion Criteria:
Clinical stage I NSCLC (T1 or T2a, N0, M0) by CT performed within 90 days of screening.
First primary NSCLC on the ipsilateral side.
At least 18 years of age.
Clinically eligible for either treatment (surgical resection or SBRT). Because this is a pragmatic study and treatment decisions are at the discretion of the treating physicians and their patients, patients must be eligible for either treatment. To be considered eligible for either treatment, patients must have:
Ability to understand and willingness to sign an IRB-approved written informed consent document.
Agrees to receive treatment for clinical stage I NSCLC (either surgical resection or SBRT).
Exclusion Criteria:
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Participants who meet the eligibility criteria from any of the participating sites listed.
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| Name | Affiliation | Role |
|---|---|---|
| Benjamin D Kozower, M.D., MPH | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory University | Atlanta | Georgia | 30322 | United States | ||
| Carle Cancer Institute |
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| Label | URL |
|---|---|
| Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine | View source |
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| Overall survival (OS) |
Overall survival (OS) is defined as time from the date of treatment to date of death. The alive patients are censored at the last follow-up. |
| Through 36 months post-treatment (estimated to be 36 months and 1 week) |
| Treated-related mortality | At 30 days (estimated to be 1 month and 1 week) |
| Number of post-treatment events (grade 3 and above) | Post-treatment grade 3-5 events measured via CTCAE version 5.0 | Through 36 months post-treatment (estimated to be 36 months and 1 week) |
| Urbana |
| Illinois |
| 61801 |
| United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| Memorial Sloan Kettering | New York | New York | 10065 | United States |
| Duke University | Durham | North Carolina | 27710 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| University of Toronto | Toronto | Ontario | Canada |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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