A Phase II Study of Cyberknife Radiosurgery for Renal Cell Carcinoma
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of Cyberknife Radiosurgery for Renal Cell Carcinoma|
- To determine the freedom from local tumor progression in patients treated with CyberKnife radiosurgery for primary renal tumors at 6 months [ Time Frame: 2 Years ] [ Designated as safety issue: No ]
- To determine impact of therapy on quality of life. [ Time Frame: 2 Years ] [ Designated as safety issue: Yes ]
- To evaluate adverse events. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
|Study Start Date:||July 2013|
|Estimated Study Completion Date:||June 2019|
|Estimated Primary Completion Date:||June 2017 (Final data collection date for primary outcome measure)|
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. (3 or 4 fractions of radiation therapy delivered by cyberknife)
Stereotactic Body Radiation Therapy. 3 or 4 fractions of radiotherapy delivered by Cyberknife.
Other Name: SBRT
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01890590
|Contact: Irving D Kaplan, MDfirstname.lastname@example.org|
|Contact: Nordine Benhaga, MDemail@example.com|
|United States, Massachusetts|
|Beth Israel Deaconess Medical Center||Recruiting|
|Boston, Massachusetts, United States, 02215|
|Contact: Irving D Kaplan, MD 617-667-2345 firstname.lastname@example.org|
|Contact: Nordine Benhaga, MD 617-667-4679 email@example.com|
|Principal Investigator: Irving D Kaplan, MD|
|Principal Investigator:||Irving D Kaplan, MD||Beth Israel Deaconess Medical Center|