A Phase II Study of Cyberknife Radiosurgery for Renal Cell Carcinoma

Condition: Renal Cell Carcinoma

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT01890590

Sponsor: Beth Israel Deaconess Medical Center


  • 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