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
608 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
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.
CONDITIONS
Official Title
A Phase II Study of Cyberknife Radiosurgery for Renal Cell Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants 18 years or older
- Histological or radiological evidence of Stage I (T1N0M0) renal cell carcinoma with tumor size no larger than 8 cm measured by MRI or CT scan
- At least one gold fiducial marker placed in or around the tumor
- No irreversible coagulopathies
- ECOG Performance Status 0, 1, or 2
- Life expectancy of at least 12 months
- Ability to undergo CT and/or MRI imaging within 120 days prior to registration
- No other cancer diagnosis in the previous 2 years except non-invasive skin cancers
- Agreement to use effective contraception if of child-bearing potential during study participation
- Ability to understand and sign informed consent
- Laboratory values within specified limits (Serum Creatinine <3 mg/dl, INR <2, PTT <70 sec, AST and ALT ≤2.5 times upper limit normal)
You will not qualify if you...
- Irreversible coagulopathies preventing fiducial placement
- Prior upper abdominal external beam radiation therapy
- History of invasive malignancy within the last 2 years
- Inability to deliver target radiation dose due to imaging or tissue constraints
- Inability to undergo contrast CT or MRI for tumor volume definition
- Low platelet count or anticoagulation issues precluding fiducial placement
AI-Screening
AI-Powered Screening
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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
CONTACT
K
Kaitlyn Scott-Haughey, M.Ed
CONTACT
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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