A Phase II Study of Cyberknife Radiosurgery for Renal Cell Carcinoma

Status: Recruiting
Phase: Phase 2
Diagnosis: Kidney Cancer
NCT ID: NCT01890590 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 12-235

 

CyberKnife Based Radiosurgery is a way to deliver large doses of radiation very accurately to a tumor. The ability of this technology to minimize radiation dose to organs adjacent to the target tumor allows a high dose to be delivered to the tumor, thus potentially increasing the efficacy of radiation treatment. Currently, radiosurgery is commonly used for brain metastases, Stage I lung cancer, spine tumors, and localized prostate cancer. The purpose of this protocol is to evaluate the role of Radiosurgery for the treatment of clinically localized primary renal cell carcinoma.

 

Conducting Institutions:
Beth-Israel Deaconess Medical Center, Dana-Farber Cancer Institute

Overall PI:
Irving Kaplan, MD, Beth Israel Deaconess Medical Center

Site-responsible Investigators:

Contacts:
Beth-Israel Deaconess Medical Center: Cancer Trials Call Center, 617-667-3060

Eligibility Criteria

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
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