Radiosurgery in Treating Patients with Stage I Kidney Cancer

Inclusion Criteria

• Participants must have histologically or radiological evidence of stage I (T1N0M0) renal cell carcinoma with a size no larger than 8 cm in greatest dimension measured by MRI or CT scan
• At least one (usually up to 3) gold fiducial placed in or around tumor, can be performed on the same day-after signing research informed consent
• No irreversible coagulopathies
• Age ≥ 18 years old because no dosing or adverse event data are currently available on the use of Cyberknife Radiosurgery radiation in participants < 18 years of age, children are excluded from this study but will be eligible for future pediatric phase II trials
• Eastern Cooperative Oncology Group (ECOG) performance status =< 2
• At least 12 month life expectancy
• Ability to have CT and/or MRI imaging with or without contrast and must be performed within 120 days prior to registration
• No other cancer in previous 2 years with the exception of non-invasive skin cancers
• All subjects meeting eligibility criteria irrespective of gender, minority or other underrepresented status will be eligible for enrollment into the study
• The effects of Cyberknife Radiosurgery on the developing human fetus are unknown. For this reason and because Radiation is known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
• Ability to understand and the willingness to sign a written informed consent document and study specific consent form prior to study entry
• Serum creatinine < 3 mg/dl
• Urinalysis; abnormalities on urinalysis (i.e. proteinuria) will not exclude patients from participation on study
• International normalized ratio (INR) < 2
• Aspartate aminotransferase (AST), alanine aminotransferase (ALT) =< 2.5 x upper limit of normal (ULN)
• Previously enrolled participants who re-meet eligibility criteria may be re-enrolled

Exclusion Criteria

• Irreversible coagulopathies that preclude fiducial placement
• Prior upper abdominal external beam irradiation
• Prior history of invasive malignancy within the last 2 years
• Inability to deliver target dose with CyberKnife due to inability to image fiducials
• Inability to deliver target dose with CyberKnife due to normal tissue dose constraints
• Inability to have contrast CT or MRI to help define tumor volume for radiation planning
• Decreased platelet count and/or anticoagulation parameters that would preclude transcutaneous placement of fiducials