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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2013-01201 | Registry Identifier | CTRP (Clinical Trial Reporting Program) |
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This pilot clinical trial studies stereotactic body radiation therapy in treating patients with metastatic kidney cancer undergoing surgery. Stereotactic radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue.
PRIMARY OBJECTIVES:
I. Assess the impact of stereotactic body radiation therapy (SBRT) on the immune system in patients with metastatic renal cell carcinoma (RCC).
SECONDARY OBJECTIVES:
I. Assess changes in immune parameters prior to radiation, post radiation and post nephrectomy.
TERTIARY OBJECTIVES:
I. Assess surgical parameters for partial or radical nephrectomy post SBRT.
OUTLINE:
Patients undergo SBRT on day 1 and undergo partial or radical nephrectomy on day 29.
After completion of study treatment, patients are followed up at 30 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (SBRT, nephrectomy) | Experimental | Patients undergo SBRT on day 1 and undergo partial or radical nephrectomy on day 29. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| stereotactic body radiation therapy | Radiation | Undergo SBRT |
|
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of conducting a partial nephrectomy in patients with no prior stereotactic radiation for kidney cancer | Up to 30 days post-treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Toxicity analysis assessed by the CTEP Version 4 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) | Up to 30 days post-treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Schwaab | Roswell Park Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Roswell Park Cancer Institute | Buffalo | New York | 14263 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28630212 | Derived | Singh AK, Winslow TB, Kermany MH, Goritz V, Heit L, Miller A, Hoffend NC, Stein LC, Kumaraswamy LK, Warren GW, Bshara W, Odunsi K, Matsuzaki J, Abrams SI, Schwaab T, Muhitch JB. A Pilot Study of Stereotactic Body Radiation Therapy Combined with Cytoreductive Nephrectomy for Metastatic Renal Cell Carcinoma. Clin Cancer Res. 2017 Sep 1;23(17):5055-5065. doi: 10.1158/1078-0432.CCR-16-2946. Epub 2017 Jun 19. |
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| therapeutic conventional surgery | Procedure | Undergo partial or radical nephrectomy |
|
| laboratory biomarker analysis | Other | Correlative studies |
|
| ID | Term |
|---|---|
| D002292 | Carcinoma, Renal Cell |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D007680 | Kidney Neoplasms |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D016634 | Radiosurgery |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D013238 | Stereotaxic Techniques |
| D019635 | Neurosurgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
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