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To assess the safety and efficacy of intensity-modulated proton therapy (IMPT) for small cell lung cancer (SCLC)
To determine the optimal schedule for three-dimensional verification imaging and necessary re-planning of patients undergoing IMPT for a rapidly changing tumor (small cell lung cancer).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prospective Study of Intensity-Modulated Proton Therapy (IMPT) | Experimental | This is the first prospective study to investigate the safety and efficacy of IMPT for the treatment of SCLC. We will utilize adaptive planning throughout the radiation course. In addition, we will study the dosimetric parameters of IMPT and their correlation with treatment-related toxicities, particularly cardiac events. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Proton-beam Therapy for Small Cell Lung Cancer | Radiation | The goal of intensity-modulated proton therapy (IMPT) is to deliver radiation to the tumor while minimizing exposure to surrounding normal tissues. |
| Measure | Description | Time Frame |
|---|---|---|
| Patients with small cell lung cancer (SCLC) will be assessed with the intensity-modulated proton therapy (IMPT). | Patients enrolled will experience <35% incidence of cardiac events at 1-year. Cardiac events included are acute heart disease, acute myocardial infarction, cardiomyopathy, dysrhythmia, heart failure, pericarditis, and pericardial effusion. | Up to 1 year from study start |
| Determination of the optimal frequency of conebeam CT during treatment and subsequent need for adaptive re-planning | The optimal frequency of conebeam CT during treatment will be determined by a mixed model:
| Up to 1,2, and 5 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kristin Higgins, MD | Contact | 404-778-0603 | kristin.higgins@emory.edu | |
| Allyson Anderson | Contact | 404-251-2854 | allyson.anderson@emory.edu |
| Name | Affiliation | Role |
|---|---|---|
| Kristin Higgins, MD | Emory University-Winship Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Winship Cancer Institute | Recruiting | Atlanta | Georgia | 30322 | United States |
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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 | Jan 1, 2019 | Mar 31, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D055752 | Small Cell Lung Carcinoma |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| ID | Term |
|---|---|
| D011522 | Protons |
| ID | Term |
|---|---|
| D002414 | Cations, Monovalent |
| D002412 | Cations |
| D007477 | Ions |
| D004573 | Electrolytes |
| D007287 |
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| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| Inorganic Chemicals |
| D006859 | Hydrogen |
| D004602 | Elements |
| D005740 | Gases |
| D000071940 | Nucleons |
| D004601 | Elementary Particles |
| D055585 | Physical Phenomena |