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| ID | Type | Description | Link |
|---|---|---|---|
| HUM00076618 | Other Identifier | University of Michigan |
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Due to changes in scanning procedure, and infeasible biopsy and baseline imaging, the trial closed for poor accrual and inability to follow patients.
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This study will assess whether Stereotactic Body Radiation Therapy (SBRT) can provide comparable local control, with similar or improved toxicity rates compared to Radio Frequency Ablation (RFA) when treating small renal cell carcinomas.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Randomized SBRT | Experimental | Patients who meet eligibility criteria (unilateral primary renal cell carcinoma less than 4 cm in greatest diameter) and are randomized to Stereotactic Body Radiation Therapy (SBRT) will receive SBRT delivered in fractions of 20 Gy, approximately every other day, for a total of three treatments. If the target is deemed too close to organs at risk, 5 fractions of up to 10 Gy per fraction will be prescribed. |
|
| Randomized RFA | Active Comparator | Patients who meet eligibility criteria (unilateral primary renal cell carcinoma less than 4 cm in greatest diameter) and are randomized to Radiofrequency Ablation (RFA) will receive RFA. |
|
| Non-Randomized SBRT | Active Comparator | Patients with renal cell carcinoma's greater than or equal to 4 cm in diameter, and up to 8 cm in diameter, may be placed in the non-randomized stereotactic body radiation therapy arm. Patients with tumors not amenable to RFA, those with metastatic disease, and those who elect a noninvasive means of treatment will also be eligible to receive treatment in the non-randomized SBRT cohort. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SBRT | Radiation |
|
| |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Patients With Local Control of Disease | On imaging, local control will be defined as when the treated lesion shows no enhancement. | 12 months |
| Cumulative Incidence of Grade 2 and Greater Toxicities | The number of patients reporting grade 2 and greater toxicities (for this trial the Common Terminology Criteria for Adverse Events or CTCAE was used). | up to 30 days after the last study treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in Quality of Life (QOL) Scores Between SBRT and RFA Treatment Arms | QOL scores will be summarized descriptively by treatment at each time point using the Convalescence and Recovery Evaluation (CARE) and SF-12 quality of life assessments . Any differences between treatment groups will be tested in the context of a general linear model with terms for treatment, time, treatment time and possibly other patient level covariates that might explain QOL. |
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Inclusion Criteria for SBRT vs. RFA Randomization:
Inclusion Criteria for non-randomized SBRT arm:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel Spratt, M.D. | University of Michigan Rogel Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan Hospital | Ann Arbor | Michigan | 48109 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Randomized SBRT | Patients who meet eligibility criteria (unilateral primary renal cell carcinoma less than 4 cm in greatest diameter) and are randomized to Stereotactic Body Radiation Therapy (SBRT) will receive SBRT delivered in fractions of 20 Gy, approximately every other day, for a total of three treatments. If the target is deemed too close to organs at risk, 5 fractions of up to 10 Gy per fraction will be prescribed. SBRT |
| FG001 | Randomized RFA | Patients who meet eligibility criteria (unilateral primary renal cell carcinoma less than 4 cm in greatest diameter) and are randomized to Radiofrequency Ablation (RFA) will receive RFA. RFA |
| FG002 | Non-Randomized SBRT | Patients with renal cell carcinoma's greater than or equal to 4 cm in diameter, and up to 8 cm in diameter, may be placed in the non-randomized stereotactic body radiation therapy arm. Patients with tumors not amenable to RFA, those with metastatic disease, and those who elect a noninvasive means of treatment will also be eligible to receive treatment in the non-randomized SBRT cohort. SBRT |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Randomized SBRT | Patients who meet eligibility criteria (unilateral primary renal cell carcinoma less than 4 cm in greatest diameter) and are randomized to Stereotactic Body Radiation Therapy (SBRT) will receive SBRT delivered in fractions of 20 Gy, approximately every other day, for a total of three treatments. If the target is deemed too close to organs at risk, 5 fractions of up to 10 Gy per fraction will be prescribed. SBRT |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Proportion of Patients With Local Control of Disease | On imaging, local control will be defined as when the treated lesion shows no enhancement. | Due to changes in the planned scanning procedure during the trial, and feasibility for patients to undergo a diagnostic biopsy and baseline imaging and following imaging requiring contrast was deemed not possible, the trial close secondary to poor accrual and patients were unable to be followed per protocol (data points not captured). | Posted | 12 months |
|
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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 | Randomized SBRT | Patients who meet eligibility criteria (unilateral primary renal cell carcinoma less than 4 cm in greatest diameter) and are randomized to Stereotactic Body Radiation Therapy (SBRT) will receive SBRT delivered in fractions of 20 Gy, approximately every other day, for a total of three treatments. If the target is deemed too close to organs at risk, 5 fractions of up to 10 Gy per fraction will be prescribed. SBRT |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Daniel Spratt, M.D. | University of Michigan Comprehensive Cancer Center | 734-936-4300 | sprattda@med.umich.edu |
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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 |
| D000078703 | Radiofrequency Ablation |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D013238 | Stereotaxic Techniques |
| D019635 | Neurosurgical Procedures |
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| RFA |
| Radiation |
|
|
| Pre-study, last day of treatment; 1, 3, 6, 12, 18, 24 and 36 months post treatment |
| Difference in Patient Time Away (Measured in Days) Between SBRT and RFA Treatment Arms | Patient time away from work/home secondary to treatment will be captured via patient questionnaire as a number of days and will be summarized descriptively by treatment group. Any differences between treatment groups will be tested by a two-sample t-test or nonparametric Mann-Whitney test. | Pre-study, last day of treatment; 1, 3, 6, 12, 18, 24 and 36 months post treatment |
| Metastasis Free Survival Time | 36 months post treatment |
| Overall Survival Time | 36 months post treatment |
| Difference in Incidence of Treatment Related Pain Between SBRT and RFA Treatment Arms | All patients will be followed to assess the development of treatment related pain, and resultant usage of analgesics (drug classification and dosage) for treatment related pain. Incidence and severity of pain will be recorded for all patients, using the Common Terminology Criteria for Adverse Events (CTCAE), as will any resultant use of analgesics, and these will be compared between the two arms and analyzed in the non-randomized SBRT cohort. | Pre-study, last day of treatment; 1, 3, 6, 12, 18, 24 and 36 months post treatment |
| BG001 | Randomized RFA | Patients who meet eligibility criteria (unilateral primary renal cell carcinoma less than 4 cm in greatest diameter) and are randomized to Radiofrequency Ablation (RFA) will receive RFA. RFA |
| BG002 | Non-Randomized SBRT | Patients with renal cell carcinoma's greater than or equal to 4 cm in diameter, and up to 8 cm in diameter, may be placed in the non-randomized stereotactic body radiation therapy arm. Patients with tumors not amenable to RFA, those with metastatic disease, and those who elect a noninvasive means of treatment will also be eligible to receive treatment in the non-randomized SBRT cohort. SBRT |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | Randomized RFA | Patients who meet eligibility criteria (unilateral primary renal cell carcinoma less than 4 cm in greatest diameter) and are randomized to Radiofrequency Ablation (RFA) will receive RFA. RFA |
| OG002 | Non-Randomized SBRT | Patients with renal cell carcinoma's greater than or equal to 4 cm in diameter, and up to 8 cm in diameter, may be placed in the non-randomized stereotactic body radiation therapy arm. Patients with tumors not amenable to RFA, those with metastatic disease, and those who elect a noninvasive means of treatment will also be eligible to receive treatment in the non-randomized SBRT cohort. SBRT |
|
| Primary | Cumulative Incidence of Grade 2 and Greater Toxicities | The number of patients reporting grade 2 and greater toxicities (for this trial the Common Terminology Criteria for Adverse Events or CTCAE was used). | Although no patients reported toxicity, the trial had poor accrual and patients were unable to be followed per protocol. | Posted | Count of Participants | Participants | up to 30 days after the last study treatment |
|
|
|
| Secondary | Difference in Quality of Life (QOL) Scores Between SBRT and RFA Treatment Arms | QOL scores will be summarized descriptively by treatment at each time point using the Convalescence and Recovery Evaluation (CARE) and SF-12 quality of life assessments . Any differences between treatment groups will be tested in the context of a general linear model with terms for treatment, time, treatment time and possibly other patient level covariates that might explain QOL. | Due to changes in the planned scanning procedure during the trial, and feasibility for patients to undergo a diagnostic biopsy and baseline imaging and following imaging requiring contrast was deemed not possible, the trial close secondary to poor accrual and patients were unable to be followed per protocol (data points not captured). | Posted | Pre-study, last day of treatment; 1, 3, 6, 12, 18, 24 and 36 months post treatment |
|
|
| Secondary | Difference in Patient Time Away (Measured in Days) Between SBRT and RFA Treatment Arms | Patient time away from work/home secondary to treatment will be captured via patient questionnaire as a number of days and will be summarized descriptively by treatment group. Any differences between treatment groups will be tested by a two-sample t-test or nonparametric Mann-Whitney test. | Due to changes in the planned scanning procedure during the trial, and feasibility for patients to undergo a diagnostic biopsy and baseline imaging and following imaging requiring contrast was deemed not possible, the trial close secondary to poor accrual and patients were unable to be followed per protocol (data points not captured). | Posted | Pre-study, last day of treatment; 1, 3, 6, 12, 18, 24 and 36 months post treatment |
|
|
| Secondary | Metastasis Free Survival Time | Due to changes in the planned scanning procedure during the trial, and feasibility for patients to undergo a diagnostic biopsy and baseline imaging and following imaging requiring contrast was deemed not possible, the trial close secondary to poor accrual and patients were unable to be followed per protocol (data points not captured). | Posted | 36 months post treatment |
|
|
| Secondary | Overall Survival Time | Due to changes in the planned scanning procedure during the trial, and feasibility for patients to undergo a diagnostic biopsy and baseline imaging and following imaging requiring contrast was deemed not possible, the trial close secondary to poor accrual and patients were unable to be followed per protocol (data points not captured). | Posted | 36 months post treatment |
|
|
| Secondary | Difference in Incidence of Treatment Related Pain Between SBRT and RFA Treatment Arms | All patients will be followed to assess the development of treatment related pain, and resultant usage of analgesics (drug classification and dosage) for treatment related pain. Incidence and severity of pain will be recorded for all patients, using the Common Terminology Criteria for Adverse Events (CTCAE), as will any resultant use of analgesics, and these will be compared between the two arms and analyzed in the non-randomized SBRT cohort. | Due to changes in the planned scanning procedure during the trial, and feasibility for patients to undergo a diagnostic biopsy and baseline imaging and following imaging requiring contrast was deemed not possible, the trial close secondary to poor accrual and patients were unable to be followed per protocol (data points not captured). | Posted | Pre-study, last day of treatment; 1, 3, 6, 12, 18, 24 and 36 months post treatment |
|
|
| 0 |
| 1 |
| 0 |
| 1 |
| 0 |
| 1 |
| EG001 | Randomized RFA | Patients who meet eligibility criteria (unilateral primary renal cell carcinoma less than 4 cm in greatest diameter) and are randomized to Radiofrequency Ablation (RFA) will receive RFA. RFA | 0 | 0 | 0 | 0 | 0 | 0 |
| EG002 | Non-Randomized SBRT | Patients with renal cell carcinoma's greater than or equal to 4 cm in diameter, and up to 8 cm in diameter, may be placed in the non-randomized stereotactic body radiation therapy arm. Patients with tumors not amenable to RFA, those with metastatic disease, and those who elect a noninvasive means of treatment will also be eligible to receive treatment in the non-randomized SBRT cohort. SBRT | 0 | 3 | 0 | 3 | 0 | 3 |
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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 |
| D000078702 | Radiofrequency Therapy |
| D055011 | Ablation Techniques |