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| ID | Type | Description | Link |
|---|---|---|---|
| 1073869 | Other Identifier | Western IRB |
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Patients with metastatic cancer are usually treated with systemic therapy (treating the entire body) with the assumption that any localized treatment of clinically apparent metastases would not impact survival. In the setting of increasingly effective systemic therapy and limited metastatic disease, aggressive treatment to clinically active sites of disease (alone or in addition to systemic therapy) may improve survival.
Up to recently it has been assumed that in the setting of metastatic solid tumors, locoregional control of clinically apparent metastases does not substantially impact survival due to undetectable micrometastic (clinically not visualized) disease that ultimately lead to treatment failure/progression. However, as more advanced systemic therapy continue to improve control of micrometastatic disease, failures at the original sites of disease remain common. Furthermore, some studies have shown locoregional treatment of limited clinical metastases to actually improve survival. Therefore, the investigators hypothesize that aggressive treatment to clinically active sites of disease (alone or in addition to systemic therapy) may improve survival or alter the course of the disease in some patients with limited metastatic disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Definitive locoregional treatment | Experimental | All sites of active disease should be treated definitively (with one of the interventions listed below). Definitive treatment does not have to be the same for all sites of disease. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Complete Surgical Removal | Procedure |
| ||
| Stereotactic Radiosurgery |
| Measure | Description | Time Frame |
|---|---|---|
| Survival | Overall and disease-specific survival, to be assessed at 1, 3, and 5 years. | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Progression free survival (PFS) | Time to first progression of disease (regardless of location) | 5 years |
| Locoregional disease control | Time to first progression within definitively treated areas |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rachel Lei, BS | Contact | 303-418-7607 | rachel.lei@usoncology.com |
| Name | Affiliation | Role |
|---|---|---|
| Dennise Carter, MD | Rocky Mountain Cancer Centers | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rocky Mountain Cancer Centers - Aurora | Recruiting | Aurora | Colorado | 80012 | United States |
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| Radiation |
|
|
| Ablative external beam radiation dose | Radiation |
|
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| Subtotal surgical removal plus ablative radiation dose | Procedure | Residual tumor or close/positive margins should be followed by ablative radiation doses (by either stereotactic radiosurgery or convential EBRT) to constitute definitive locoregional treatment |
|
|
| Radioembolization | Radiation | radioembolization of the liver with Y-90 microspheres or other site-appropriate techniques |
|
|
| 5 years |
| Toxicity | Including grade 2+ toxicity attributable to localized study treatment as well as to systemic therapy | 5 years |
| Rocky Mountain Cancer Centers - Boulder | Recruiting | Boulder | Colorado | 80303 | United States |
|
| Rocky Mountain Cancer Centers - Littleton | Recruiting | Littleton | Colorado | 80120 | United States |
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| Rocky Mountain Cancer Centers - Thornton | Recruiting | Thornton | Colorado | 80260 | United States |
|
| ID | Term |
|---|---|
| D012008 | Recurrence |
| D012509 | Sarcoma |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009385 | Neoplastic Processes |
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| ID | Term |
|---|---|
| D016634 | Radiosurgery |
| D013097 | Spermine Synthase |
| C000615496 | Yttrium-90 |
| D008863 | Microspheres |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D013238 | Stereotaxic Techniques |
| D019635 | Neurosurgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
| D019883 | Alkyl and Aryl Transferases |
| D014166 | Transferases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D004864 | Equipment and Supplies |
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