A Phase II Study of Cyberknife Radiosurgery for Renal Cell Carcinoma (NCT01890590)

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

1. Participants must meet the following criteria on screening examination to be eligible to participate in the study:
2. 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
3. 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.
4. No irreversible coagulopathies
5. 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.
6. ECOG Performance Status ≤2 (Appendix A).
7. At least 12 month life expectancy
8. Ability to have CT and/or MRI imaging with or without contrast and must be performed within 120 days prior to registration.
9. No other cancer in previous 2 years with the exception of non-invasive skin cancers
10. All subjects meeting eligibility criteria irrespective of gender, minority or other underrepresented status will be eligible for enrollment into the study.
11. 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.
12. Ability to understand and the willingness to sign a written informed consent document and study specific consent form prior to study entry.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

• Beth Israel Deaconess Medical Center — Boston, Massachusetts

💰 Cost, Insurance & Patient Rights

• 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
• Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
• Voluntary Participation: You may withdraw at any time without affecting your standard medical care.