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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-0286 | Other Identifier | Institutional Review Board | |
| NCI-2016-00775 | Registry Identifier | NCI Trial ID | |
| A533300 | Other Identifier | UW Madison | |
| SMPH\HUMAN ONCOLOGY\HUMAN ONCO | Other Identifier | UW Madison | |
| Protocol Version 4/16/2019 | Other Identifier | UW Madison |
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slow accrual
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The specific aims of this study are:
Renal cell carcinoma is traditionally managed via a surgical approach. Increasingly, local therapy with radiofrequency and microwave ablation is being utilized as an alternative for patients who may not tolerate a nephrectomy or who refuse one. Although local control rates for small lesions are excellent, they drop off precipitously for lesions over 4 cm. Furthermore, lesions in critical areas such as the renal hilum may be difficult to treat with this method. Stereotactic body radiation therapy (SBRT) has had a long record of treating patients with inoperable tumors in locations such as the lung and central nervous system, and there is increasing evidence that it may be useful for patients with renal cell carcinoma. The recent emergence of MRI-guided radiation therapy allows for direct visualization of tumors during treatment, and may potentially allow clinicians to treat tumors more precisely. This phase I study will treat renal cell carcinoma patients using a combination of MRI-guided stereotactic body radiation therapy and microwave ablation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Radiotherapy & Microwave Ablation | Experimental | 3+3 dose-escalation wherein three dose levels of stereotactic body radiation therapy (SBRT) would be evaluated:
Radiation treatments will be delivered two to three times a week, with five fractions completed over two weeks. Four to six weeks after radiation treatment, patients will undergo repeat CT or MRI imaging to assess tumor response and suitability for microwave ablations. Eight weeks after the conclusion of SBRT, patients will undergo microwave ablation (approximately 12 weeks after registration). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stereotactic Body Radiation Therapy (SBRT) | Radiation | Patients will be treated on study with a course of SBRT treatment by a radiation oncologist. Three SBRT dose levels targeting the primary tumor will be evaluated; level I: 6 Gy x 5 fractions (a common palliative dose), level II: 8 Gy x 5 fractions, and level III: 10 Gy x 5 fractions (a common definitive dose). |
| Measure | Description | Time Frame |
|---|---|---|
| Dose-limiting Toxicity With SBRT Combined With Microwave Ablation for Renal Cell Carcinoma | Dose-limiting toxicity (DLT) will be defined as grade 4 or higher non-hematologic toxicity attributable to treatment. This will exclude toxicities not caused by treatment, such as pain due to tumor progression. Toxicities will be defined per NCI CTCAE v5.0. | Until 30 days after ablation (up to 12 weeks on study) |
| Measure | Description | Time Frame |
|---|---|---|
| Local Control Rate Per RECIST Criteria as Reported by Count of Participants | Radiologic response per RECIST criteria and volumetric measurements. | 8 weeks |
| Progression Free Survival | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Tumor Pathology of Post-SBRT Specimen (Pathologic Evaluation) | Pathologic evaluation for percentage of viable tumor remaining as measured by the presence of necrosis, fibrosis, hyalinization, and/or calcification, compared to pre-SBRT pathology | 8 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Bassetti | University of Wisconsin, Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Wisconsin Carbone Cancer Center | Madison | Wisconsin | 53705 | United States |
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| Label | URL |
|---|---|
| UW Carbone Cancer Center Home Page | View source |
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Participants were enrolled from June 2018 to September 2022.
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| ID | Title | Description |
|---|---|---|
| FG000 | Radiotherapy & Microwave Ablation | 3+3 dose-escalation wherein three dose levels of stereotactic body radiation therapy (SBRT) would be evaluated:
Radiation treatments will be delivered two to three times a week, with five fractions completed over two weeks. Four to six weeks after radiation treatment, patients will undergo repeat CT or MRI imaging to assess tumor response and suitability for microwave ablations. Eight weeks after the conclusion of SBRT, patients will undergo microwave ablation (approximately 12 weeks after registration). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Radiotherapy & Microwave Ablation | 3+3 dose-escalation wherein three dose levels of stereotactic body radiation therapy (SBRT) would be evaluated:
Radiation treatments will be delivered two to three times a week, with five fractions completed over two weeks. Four to six weeks after radiation treatment, patients will undergo repeat CT or MRI imaging to assess tumor response and suitability for microwave ablations. Eight weeks after the conclusion of SBRT, patients will undergo microwave ablation (approximately 12 weeks after registration). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | 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 | Dose-limiting Toxicity With SBRT Combined With Microwave Ablation for Renal Cell Carcinoma | Dose-limiting toxicity (DLT) will be defined as grade 4 or higher non-hematologic toxicity attributable to treatment. This will exclude toxicities not caused by treatment, such as pain due to tumor progression. Toxicities will be defined per NCI CTCAE v5.0. | 1 participant did not undergo ablation | Posted | Number | dose limiting toxicities | Until 30 days after ablation (up to 12 weeks on study) |
|
up to 12 weeks
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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 | Radiotherapy & Microwave Ablation | 3+3 dose-escalation wherein three dose levels of stereotactic body radiation therapy (SBRT) would be evaluated:
Radiation treatments will be delivered two to three times a week, with five fractions completed over two weeks. Four to six weeks after radiation treatment, patients will undergo repeat CT or MRI imaging to assess tumor response and suitability for microwave ablations. Eight weeks after the conclusion of SBRT, patients will undergo microwave ablation (approximately 12 weeks after registration). |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| anemia | Blood and lymphatic system disorders | CTCAE v4.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael Bassetti, MD, PhD | University of Wisconsin School of Medicine and Public Health | 608-263-8500 | bassetti@humonc.wisc.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 16, 2019 | Jan 30, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D002292 | Carcinoma, Renal Cell |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D016634 | Radiosurgery |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D013238 | Stereotaxic Techniques |
| D019635 | Neurosurgical Procedures |
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| Microwave Ablation (MWA) | Procedure | Performed under sedation using ultrasound and computed tomography (CT) guidance for percutaneous antenna placement and confirmation. Depending on size and location of tumor, one to three antennas (Certus 140; NeuWave Medical) will be used. The system is an FDA-approved, high-powered third-generation MW device that uses CO2 gas cooling to prevent shaft heating. The gas cooling allows the probes to be stuck into tissue by creating a small ice ball at the tip using the Joule-Thomson method, similar to the tissue cooling mechanism of cryoablation systems. Probes are 17-gauge, and various ablation zone configurations are available depending on the probe selected. An ablation protocol using the 65W power setting for 5 minutes will be used for most patients. Ultrasound will be used for real-time monitoring of the extent of ablation to achieve a 5mm margin beyond tumor, and immediate post-procedure imaging performed using contrast-enhanced CT (CECT) for patients with adequate renal functions. |
|
| Overall Survival | 8 weeks |
| Tumor Pathology of Post-SBRT Specimen (H&E Staining) | H&E staining for percentage of viable tumor remaining as measured by the presence of necrosis, fibrosis, hyalinization, and/or calcification, compared to pre-SBRT pathology | 8 weeks |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Secondary | Local Control Rate Per RECIST Criteria as Reported by Count of Participants | Radiologic response per RECIST criteria and volumetric measurements. | Posted | Count of Participants | Participants | 8 weeks |
|
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| Secondary | Progression Free Survival | Posted | Count of Participants | Participants | 8 weeks |
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| Secondary | Overall Survival | Posted | Count of Participants | Participants | 8 weeks |
|
|
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| Secondary | Tumor Pathology of Post-SBRT Specimen (H&E Staining) | H&E staining for percentage of viable tumor remaining as measured by the presence of necrosis, fibrosis, hyalinization, and/or calcification, compared to pre-SBRT pathology | tumor pathology was not analyzed as study was terminated early, no data collected | Posted | 8 weeks |
|
|
| Other Pre-specified | Tumor Pathology of Post-SBRT Specimen (Pathologic Evaluation) | Pathologic evaluation for percentage of viable tumor remaining as measured by the presence of necrosis, fibrosis, hyalinization, and/or calcification, compared to pre-SBRT pathology | Not Posted | 8 weeks | Participants |
| 0 |
| 3 |
| 0 |
| 3 |
| 2 |
| 3 |
| lymphopenia | Immune system disorders | CTCAE v4.0 | Systematic Assessment |
|
| headache | General disorders | CTCAE v4.0 | Systematic Assessment |
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| Fatigue | General disorders | CTCAE v4.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | CTCAE v4.0 | Systematic Assessment |
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| back pain | Musculoskeletal and connective tissue disorders | CTCAE v4.0 | Systematic Assessment |
|
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| 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 |
| D013514 |
| Surgical Procedures, Operative |
| D008919 | Investigative Techniques |