Condition: Renal Cell Carcinoma

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT01890590

Sponsor: Beth Israel Deaconess Medical Center

Eligibility:

• Age: minimum 18 Years maximum N/A
• Gender: All

Inclusion Criteria:

• Participants must meet the following criteria on screening examination to be eligible to participate in the study:
• 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.
• ECOG Performance Status ≤2 (Appendix A).
• 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.
• Labs: Serum Creatinin <3 mg/dl, Urinalysis, INR <2, PTT <70 sec, AST, ALT ≤2.5x ULN, Abnormalities on urinalysis (i.e. proteinuria) will not exclude patients from participation on study.

Exclusion Criteria:

• Participants who exhibit any of the following conditions at screening will not be eligible for admission into the study.
• 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

View trial on ClinicalTrials.gov