Stereotactic Ablative Body Radiation Therapy for Patients With Primary Renal Cancer
Conditions
Renal Cancers
Conditions: official terms
Carcinoma, Renal Cell - Kidney Neoplasms
Conditions: Keywords
renal cancer
Study Type
Interventional
Study Phase
Phase 2
Study Design
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Stereotactic Ablative Radiation Therapy
Type: Radiation
Overall Status
Recruiting
Summary
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.
Detailed 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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: 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.
Location
University of Texas Southwestern
Dallas, Texas, United States
Status: Recruiting
Start Date
June 2014
Completion Date
December 2018
Sponsors
University of Texas Southwestern Medical Center
Source
University of Texas Southwestern Medical Center
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page