A Phase II Study of Cyberknife Radiosurgery for Renal Cell Carcinoma
Brief description of study
CyberKnife Based Radiosurgery is a way to deliver large doses of radiation very accurately
to a tumor. The ability of this technology to minimize radiation dose to organs adjacent to
the target tumor allows a high dose to be delivered to the tumor, thus potentially
increasing the efficacy of radiation treatment. Currently, radiosurgery is commonly used for
brain metastases, Stage I lung cancer, spine tumors, and localized prostate cancer. The
purpose of this protocol is to evaluate the role of Radiosurgery for the treatment of
clinically localized primary renal cell carcinoma.
Clinical Study Identifier: NCT01890590
Detailed Study Description
Before the research starts (screening) Many of these tests and procedures are likely to be
part of regular cancer care and may be done even if it turns out that you do not take part
in the research study. If you have had some of these tests or procedures recently, they may
or may not have to be repeated.
- A medical history, which includes questions about your health, current medications, and
- Performance status, which evaluates how you are able to carry on with your usual
- Quality of life survey.
- Gold seed (Fiducial) Placement: Placement of at least one (usually up to 3) gold
fiducial(s) must be placed in or around the tumor by a surgeon or interventional
radiologist a minimum of one week or more prior to pre-treatment planning simulation.
- An assessment of your tumor by X-ray, CT (Computerized Tomography) scan, MRI (Magnetic
Resonance Imaging) or PET (Positron Emission Tomography) scans.
- Blood tests.
- Urine test.
- You will undergo a simulation of the intervention procedure. It will involve the study
team helping you position yourself for the study procedure as you undergo a CT scan of
the abdomen while holding the correct position.
If these tests show that you are eligible to participate in the research study, you will
begin the study treatment. If you do not meet the eligibility criteria, you will not be
able to participate in this research study.
After the screening procedures confirm that you are eligible to participate in the research
You will receive a series of Cyberknife Radiosurgery treatments, with the amount of
radiation dosing adjusted for the size of your tumor. The treatment will ideally take place
over the course of 3-4 days, but not more than 14 days overall.
You will be positioned in a stable position laying on your back, capable for reproducibility
of positioning and not allowing you to move from simulation to treatment, allowing you to
feel as comfortable as possible. A variety of systems may be utilized to keep you still;
including vacuum bag, alpha cradle, or stereotactic frames that surround you on three sides
and large rigid pillows conforming to your body.
After the final dosing We would like to keep track of your medical condition for the rest of
your life. We would like to do this by calling you on the telephone once a year to see how
you are doing. Keeping in touch with you and checking your condition every year helps us
look at the long-term effects of the research study.