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CTC levels collected pre-surgery will be correlated with pathological samples.
Patients with NSCLC who undergo radiation as part of a definitive course of treatment will be enrolled. Blood collections will be obtained before, during, and after radiotherapy. We will collect demographic and treatment data and explore & describe the pattern of CTC detection in all patients
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Patients with early stage NSCLC undergoing stereotactic radiotherapy |
| |
| Cohort 2 | Patients with locally advanced NSCLC undergoing standard chemoradiotherapy |
| |
| Cohort 3 | Patients with stage I-III NSCLC undergoing standard, fractionated radiotherapy alone |
| |
| Cohort 4 | Patients with locally advanced NSCLC undergoing standard chemoradiotherapy with the novel signal transduction inhibitor, nelfianvir. |
| |
| Cohort 5 | Patients with resectable stage IIIa NSCLC undergoing pre-operative chemoradiotherapy |
| |
| Cohort 6 | Patients with suspected (no tissue diagnosis) early stage NSCLC undergoing stereotactic radiotherapy |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiotherapy | Radiation |
|
| Measure | Description | Time Frame |
|---|---|---|
| To Describe the Pattern of CTCs Before and After Definitive Radiotherapy for Each Treatment Stratum | The pattern of CTCs before and after definitive radiotherapy for each treatment stratum. CTC counts per mL before and after definitive radiotherapy. | 24 months |
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Inclusion Criteria:
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NSCLC patients
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| Name | Affiliation | Role |
|---|---|---|
| Steven Feigenberg, MD | Abramson Cancer Center at Penn Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Abramson Cancer Center of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38095673 | Derived | Evanson D, Griffin M, O'Reilly SE, Johnson T, Werner T, Kothekar E, Jahangiri P, Simone CB 2nd, Swisher-McClure S, Feigenberg SJ, Revheim ME, Zou J, Alavi A. Comparative assessment of radiation therapy-induced vasculitis using [18F]FDG-PET/CT in patients with non-small cell lung cancer treated with proton versus photon radiotherapy. Eur J Nucl Med Mol Imaging. 2024 Apr;51(5):1444-1450. doi: 10.1007/s00259-023-06535-3. Epub 2023 Dec 14. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1 | Patients with early stage NSCLC undergoing stereotactic radiotherapy Radiotherapy |
| FG001 | Cohort 2 | Patients with locally advanced NSCLC undergoing standard chemoradiotherapy Radiotherapy |
| FG002 | Cohort 3 | Patients with stage I-III NSCLC undergoing fractionated radiotherapy alone Radiotherapy |
| FG003 | Cohort 4 | Patients with locally advanced NSCLC undergoing standard chemoradiotherapy with the signal transduction inhibitor, nelfianvir. Radiotherapy |
| FG004 | Cohort 5 | Patients with resectable stage IIIa NSCLC undergoing pre-operative chemoradiotherapy Radiotherapy |
| FG005 | Cohort 6 | Patients with suspected (no tissue diagnosis) early stage NSCLC undergoing stereotactic radiotherapy Radiotherapy |
| FG006 | Cohort 7 | Patients with locally advanced NSCLC undergoing stereotactic radiotherapy followed by concurrent mediastinal chemoradiotherapy |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
There was no eligible participant for cohort 4 and cohort 7
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1 | Patients with early stage NSCLC undergoing stereotactic radiotherapy Radiotherapy |
| BG001 | Cohort 2 | Patients with locally advanced NSCLC undergoing standard chemoradiotherapy Radiotherapy |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | To Describe the Pattern of CTCs Before and After Definitive Radiotherapy for Each Treatment Stratum | The pattern of CTCs before and after definitive radiotherapy for each treatment stratum. CTC counts per mL before and after definitive radiotherapy. | There were no enrolled patients in Cohorts 4 and 7. The Overall Number of Participants Analyzed in the Arms/Groups is not consistent with numbers provided in the Participant Flow module because not all patients underwent sequential (multiple) assays necessary for analysis. Only 114 out of 204 patients fulfilled the analysis criteria such as sequential PET/CT scans performed in the home institution. | Posted | Median | Full Range | CTCs/mL | 24 months |
|
Adverse events were not followed or reported for this protocol.
Adverse events were not followed or reported for this protocol.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cohort 1 | Patients with early stage NSCLC undergoing stereotactic radiotherapy Radiotherapy |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ching Lai | University of Pennsylvania | 267-250-9244 | ching.lai@pennmedicine.upenn.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 2, 2021 | May 3, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| Cohort 7 | Patients with locally advanced NSCLC undergoing stereotactic radiotherapy followed by concurrent mediastinal chemoradiotherapy |
|
| BG002 | Cohort 3 | Patients with stage I-III NSCLC undergoing fractionated radiotherapy alone Radiotherapy |
| BG003 | Cohort 4 | Patients with locally advanced NSCLC undergoing standard chemoradiotherapy with the signal transduction inhibitor, nelfianvir Radiotherapy |
| BG004 | Cohort 5 | Patients with resectable stage IIIa NSCLC undergoing pre-operative chemoradiotherapy Radiotherapy |
| BG005 | Cohort 6 | Patients with suspected (no tissue diagnosis) early stage NSCLC undergoing stereotactic radiotherapy Radiotherapy |
| BG006 | Cohort 7 | Patients with locally advanced NSCLC undergoing stereotactic radiotherapy followed by concurrent mediastinal chemoradiotherapy |
| BG007 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Median | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Biopsy-Proven Non-Small Cell Lung Cancer | Count of Participants | Participants |
|
| OG001 |
| Cohort 2 |
Patients with locally advanced NSCLC undergoing standard chemoradiotherapy Radiotherapy |
| OG002 | Cohort 3 | Patients with stage I-III NSCLC undergoing fractionated radiotherapy alone Radiotherapy |
| OG003 | Cohort 4 | Patients with locally advanced NSCLC undergoing standard chemoradiotherapy with the signal transduction inhibitor, nelfianvir Radiotherapy |
| OG004 | Cohort 5 | Patients with resectable stage IIIa NSCLC undergoing pre-operative chemoradiotherapy Radiotherapy |
| OG005 | Cohort 6 | Patients with suspected (no tissue diagnosis) early stage NSCLC undergoing stereotactic radiotherapy Radiotherapy |
| OG006 | Cohort 7 | Patients with locally advanced NSCLC undergoing stereotactic radiotherapy followed by concurrent mediastinal chemoradiotherapy |
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Cohort 2 | Patients with locally advanced NSCLC undergoing standard chemoradiotherapy Radiotherapy | 0 | 0 | 0 | 0 | 0 | 0 |
| EG002 | Cohort 3 | Patients with stage I-III NSCLC undergoing fractionated radiotherapy alone Radiotherapy | 0 | 0 | 0 | 0 | 0 | 0 |
| EG003 | Cohort 4 | Patients with locally advanced NSCLC undergoing standard chemoradiotherapy with the signal transduction inhibitor, nelfianvir Radiotherapy | 0 | 0 | 0 | 0 | 0 | 0 |
| EG004 | Cohort 5 | Patients with resectable stage IIIa NSCLC undergoing pre-operative chemoradiotherapy Radiotherapy | 0 | 0 | 0 | 0 | 0 | 0 |
| EG005 | Cohort 6 | Patients with suspected (no tissue diagnosis) early stage NSCLC undergoing stereotactic radiotherapy Radiotherapy | 0 | 0 | 0 | 0 | 0 | 0 |
| EG006 | Cohort 7 | Patients with locally advanced NSCLC undergoing stereotactic radiotherapy followed by concurrent mediastinal chemoradiotherapy | 0 | 0 | 0 | 0 | 0 | 0 |
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| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |