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The goal of this phase II clinical trial is to evaluate the efficacy of the completely non-invasive treatment option of stereotactic radiation therapy for the treatment of biopsy proven and growing small renal tumors.
Current treatment options for primary renal cancer include surgery or ablative techniques-all are invasive or minimally invasive options. The completely noninvasive treatment option of stereotactic radiation therapy (SABR), which has become standard of care in many cancer sites, has not been explored for primary renal cancer. With multiple technological advances, it is now feasible to safely treat a moving intra-abdominal tumor such as that in a kidney. This proposed clinical trial evaluates the efficacy of SABR in treating patients with early renal cancers. Growing renal masses will first be biopsied to confirm the diagnosis of renal cancer. Patients will then undergo treatment with SABR of 3-5 fractions completing within three weeks. Treatment response will be evaluated using sequential MRI scans and a second tumor biopsy one year after treatment. Monitoring of treatment toxicity and kidney function will also be performed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stereotactic Ablative Radiation Therapy | Experimental | Stereotactic Ablative Radiation Therapy (SABR) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stereotactic Ablative Radiation Therapy | Radiation | Stereotactic Ablative Body Radiation Therapy (SABR): 3 fractions of 12Gy, or 4 fractions of 10Gy or 5 fractions of 8 Gy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Eliminate its growth and tumor viability. | To evaluate if SABR to small renal tumors is able to eliminate its growth and viable tumor. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | To describe the adverse events associated with the administration of SABR to renal tumors. | 2 years |
| growth rate of renal tumors | To measure the growth rate of renal tumors after SABR treatment. |
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Inclusion Criteria
Age ≥ 18 years.
Renal mass ≤ 5cm
Biopsy proven Renal neoplasm
Growth of renal mass >2mm in radiographic scans must be demonstrated within a one year period.
Ability to understand and the willingness to sign a written informed consent.
Subject is able to undergo either an MRI or administration of contrast agent for CT
Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) for the duration of the study. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
Exclusion Criteria:
Subject has received any treatment for the treating renal mass; such as RFA or cyroablation.
Subjects received previous abdominal radiation
Evidence of Metastatic Disease, unless disease-free for ≥ 3 years prior to registration, (non-melanomatous skin cancer and in-situ cancers are okay).
Female subjects who are pregnant or planning to become pregnant during the course of SABR.
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| Name | Affiliation | Role |
|---|---|---|
| Raquibul Hannan, MD, PhD | UTSW | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas Southwestern | Dallas | Texas | 75239 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 19, 2020 | Aug 31, 2020 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D007680 | Kidney Neoplasms |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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|
| 2 years |
| Renal function | To measure the changes in kidney function, creatinine levels, renal perfusion and GFR after SABR treatment | 2 years |
| Tumor Viability | To measure tumor viability pathologically one year after SABR treatment with biopsy. | one year |
| progression of disease | To assess radiographic changes to the renal tumor after SABR treatment including tumor viability, enhancement necrosis,T2 tumor cellularity with diffusion-weighted imaging. To assess local, regional and systemic progression of disease after SABR to SRM .To assess time to progression (TTP) of disease from the first SABR treatment. To assess progression free survival (PFS). PFS is defined as the length of time from start of treatment to the time of loco-regional disease progression or death from any cause. To assess overall survival (OS). OS is defined as the duration of time from start of treatment to the time of death from any cause. To assess tumor growth, local failure and indeterminate disease response (IDR). | 2 years |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |