Clinical Trial Details
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NCT01890590 : A Phase II Study of Cyberknife Radiosurgery for Renal Cell Carcinoma
PhasePhase 2
AgesMin: 18 Years Max: N/A
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

- Inability to have contrast CT or MRI to help define tumor volume for radiation

- Decreased platelet count and / or anticoagulation parameters that would preclude
transcutaneous placement of fiducials
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