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| ID | Type | Description | Link |
|---|---|---|---|
| 10-000656 | Other Identifier | UCLA/Jonsson Comprehensive Cancer Center |
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The purpose of this study is to demonstrate that combined stereotactic body radiotherapy and radiofrequency ablation is safe for patients with lung tumors near central airways.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental | Subjects will undergo PET/CT simulation, 3 Fraction SBRT, RFA, and then undergo follow up. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stereotactic Body Radiation | Radiation | 3 fraction of stereotactic body radiation therapy within 10 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Achieve at most of 20% subacute or chronic grade 3 or higher lng, cardiac, or upper GI toxicity rate in patients treated with SBRT/RFA. | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Achieve no more than 15% decline from the pre-treatment pulmonary function parameter (FEV1, DLCO) post-SBRT/RFA. | 3 years | |
| Achieve at least a 80% one-year local control (LC) rate by RECIST criterion or PET response (if applicable). | 3 years |
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Inclusion Criteria:
Histologically confirmed primary lung cancer, lung metastasis from another primary, or recurrent tumors in the setting of prior RFA or cryotherapy
Tumors < 2 cm from trachea or zone of proximal bronchial tree (central tumors)
Each tumor < 5 cm in size prior to treatment
Medically inoperable patients as determined at the multidisciplinary thoracic tumor board, or medically operable patients who refuse surgery
Criterion for medical inoperability include:
Modified ACOSOG Criteria for medical inoperability:
Age > 18 years old
KPS > 70
If a woman is of childbearing potential, a negative urine or serum pregnancy test must be documented.
Ability to understand and the willingness to sign a written informed consent
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Percy Lee, MD | University of California, Los Angeles | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCLA Jonsson Comprehensive Cancer Center | Los Angeles | California | 90095 | United States |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Sep 1, 2020 | |
| Reset | Sep 25, 2020 | |
| Release | May 12, 2021 | |
| Reset | Jun 7, 2021 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Sep 1, 2020 | Sep 25, 2020 | |||
| May 12, 2021 |
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D016634 | Radiosurgery |
| D000078703 | Radiofrequency Ablation |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D013238 | Stereotaxic Techniques |
| D019635 | Neurosurgical Procedures |
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| Radiofrequency Ablation | Radiation | Subject will undergo radiofrequency ablation within 10 days of the last fraction of SBRT. |
|
|
| Progression-free survival | 3 years |
| Overall survival | 3 years |
| Concentration of serum TGF-B as early biomarker for treatment-inducted normal tissue injury | 3 years |
| Concentration of serum VEGF as an early biomarker for response | 3 years |
| Jun 7, 2021 |
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D013514 |
| Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
| D000078702 | Radiofrequency Therapy |
| D055011 | Ablation Techniques |