Stereotactic Ablative Body Radiation Therapy for Patients With Primary Renal Cancer
| Status: | Recruiting |
|---|---|
| Conditions: | Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - 99 |
| Updated: | 7/20/2018 |
| Start Date: | June 2014 |
| End Date: | December 2021 |
| Contact: | Raquibul Hannan, MD, PhD |
| Phone: | 214-645-8525 |
A Phase II Trial of Stereotactic Ablative Body Radiation Therapy (SABR) for Patients With Primary Renal Cancer (RCC)
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.
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.
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.
Inclusion Criteria
- Age ≥ 18 years.
- Renal mass ≤ 3cm
- Biopsy proven Renal neoplasm
- All histology of renal cancers are included including oncocytoma
- Growth of renal mass >4mm in radiographic scans or >2mm in two different scans must be
demonstrated within a one year period.
- Ability to understand and the willingness to sign a written informed consent.
- No clinical evidence of metastatic disease
Exclusion Criteria:
- Subjects may not have received any treatment for the renal mass before such as RFA or
cryoablation.
- Subjects must not have received previous abdominal radiation
- Subjects must be able to undergo either an MRI or administration of contrast agent for
CT.
- Subjects unable to undergo either of the imaging study will be excluded.
- Subjects enrolled on the study and then became unable to undergo either of the
imaging study will be either replaced or decided on an individual basis by the
investigator (please see section 5.5)
- Subjects must not be pregnant during the course of SABR.
We found this trial at
1
site
Dallas, Texas 75390
Principal Investigator: Raquibul Hannan, MD, PhD
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