Stereotactic Ablative Body Radiation Therapy for Patients With Primary Renal Cancer

Study ID
STU 122013-030

Study Sites

  • Clements University Hospital

Contact
Sarah Neufeld
214/648-1836
Sarah.Hardee@UTSouthwestern.edu

Principal Investigator
Raquibul Hannan, M.D., Ph.D.

Official Title

A Phase II Trial of Stereotactic Ablative Body Radiation Therapy (SABR) for Patients With Primary Renal Cancer (RCC)

Brief Overview

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.

Description

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.

Eligibility

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.