Actively Recruiting
A Phase II Study of CyberKnife Radiosurgery for Renal Cell Carcinoma
Led by Beth Israel Deaconess Medical Center · Updated on 2024-08-15
46
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
Sponsors
B
Beth Israel Deaconess Medical Center
Lead Sponsor
D
Dana-Farber Cancer Institute
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the use of CyberKnife Radiosurgery to treat clinically localized primary renal cell carcinoma, a type of kidney cancer. This technology delivers high doses of radiation very precisely to the tumor while minimizing exposure to nearby organs. The study aims to understand how well this treatment controls tumor growth and its effects on patients, focusing on those with early-stage kidney cancer (Stage I). Participants will receive CyberKnife Radiosurgery, with the radiation dose adjusted according to tumor size. Treatment typically occurs over 3 to 4 days, but can extend up to 14 days. Before treatment, gold fiducials (small markers) are placed near the tumor to guide the radiation. During treatment, participants will be positioned carefully using devices like vacuum bags or rigid pillows to keep still and comfortable. Before starting, participants undergo tests such as imaging scans (CT, MRI, PET), blood and urine tests, a medical history review, and quality of life surveys. After treatment, researchers will monitor participants long-term, including annual phone calls to check health status. The main outcome is to measure freedom from tumor growth at 6 months and up to 2 years, along with quality of life and any side effects over 2 years.
CONDITIONS
Brief Title
A Phase II Study of Cyberknife Radiosurgery for Renal Cell Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must have Stage I (T1N0M0) renal cell carcinoma with tumor size no larger than 8 cm based on MRI or CT
- Placement of at least one (up to 3) gold fiducials in or around the tumor
- No irreversible bleeding disorders that prevent fiducial placement
- Age 18 years or older
- ECOG Performance Status of 2 or less
- At least 12 months life expectancy
- Ability to have CT and/or MRI imaging within 120 days prior to registration
- No other cancer in the past 2 years except non-invasive skin cancers
- Use of adequate contraception by women of childbearing potential and men during the study
- Ability to understand and sign informed consent
- Labs within specified limits: Serum Creatinine <3 mg/dl, INR <2, PTT <70 sec, AST and ALT ≤2.5 times upper limit of normal
You will not qualify if you...
- Irreversible coagulopathies preventing fiducial placement
- Prior upper abdominal external beam radiation therapy
- History of invasive cancer within the last 2 years
- Inability to deliver target radiation dose due to imaging or normal tissue constraints
- Inability to undergo contrast CT or MRI needed for radiation planning
- Low platelet count or anticoagulation parameters that prevent transcutaneous fiducial placement
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for medical history, imaging, blood and urine tests, and gold fiducial placement
Duration - 3 to 14 days
Participants receive CyberKnife radiosurgery treatments, with radiation dosing adjusted for tumor size.
3 to 4 treatment visits over 3 to 14 days
Duration - Up to lifetime
Participants are followed up by yearly phone calls to track medical condition and long-term effects of the treatment.
Annual phone call follow-up
Trial Site Locations
Total: 1 location
1
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Actively Recruiting
Research Team
I
Irving D Kaplan, MD
K
Kaitlyn Scott-Haughey, M.Ed
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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