A Phase II Study of Cyberknife Radiosurgery for Renal Cell Carcinoma

Renal Cell Carcinoma Clinical Trial

Official title: A Phase II Study of Cyberknife Radiosurgery for Renal Cell Carcinoma

Status Recruiting

Clinical Trial Summary

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 Trial 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 any allergies.

• Performance status, which evaluates how you are able to carry on with your usual activities.

• 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 study:

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. ;

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Renal Cell
• Renal Cell Carcinoma

• NCT number: NCT01890590
• Study type: Interventional
• Source: Dana-Farber Cancer Institute
• Contact: Irving D Kaplan, MD
• Phone: 617-667-2345
• Email: ikaplan@caregroup.harvard.edu
• Status: Recruiting
• Phase: N/A
• Start date: July 2013
• Completion date: December 2023