NCT01890590 A Phase II Study of Cyberknife Radiosurgery for Renal Cell Carcinoma
| NCT ID | NCT01890590 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Beth Israel Deaconess Medical Center |
| Condition | Renal Cell Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 46 participants |
| Start Date | 2013-07 |
| Primary Completion | 2025-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 46 participants in total. It began in 2013-07 with a primary completion date of 2025-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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
Contact & Investigator
Irving D Kaplan, MD
PRINCIPAL INVESTIGATOR
Beth Israel Deaconess Medical Center
Frequently Asked Questions
Who can join the NCT01890590 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Renal Cell Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT01890590 currently recruiting?
Yes, NCT01890590 is actively recruiting participants. Contact the research team at ikaplan@caregroup.harvard.edu for enrollment information.
Where is the NCT01890590 trial being conducted?
This trial is being conducted at Boston, United States.
Who is sponsoring the NCT01890590 clinical trial?
NCT01890590 is sponsored by Beth Israel Deaconess Medical Center. The principal investigator is Irving D Kaplan, MD at Beth Israel Deaconess Medical Center. The trial plans to enroll 46 participants.