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Phase II CyberKnife Radiosurgery for Renal Cell Carcinoma

This study is looking at how well CyberKnife radiosurgery works for people with early-stage kidney cancer (renal cell carcinoma). CyberKnife is a way to deliver high doses of radiation very precisely to a tumor, aiming to increase treatment effectiveness while reducing radiation to healthy organs nearby. You might be able to join if you are 18 or older and have Stage I kidney cancer, no larger than 8 cm, confirmed by imaging or biopsy. The main goal is to see how many people are free from local tumor growth after 6 months, with results measured at 2 years. The study is currently unclear about its recruitment status and plans to enroll 46 participants.

Study design
This is an interventional study planning to enroll 46 participants. It is evaluating CyberKnife radiosurgery for renal cell carcinoma.
What's involved
Before treatment, you will have a medical history, performance status check, quality of life survey, gold seed placement near the tumor, imaging scans (X-ray, CT, MRI, or PET), blood tests, urine tests, and a simulation of the procedure.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome of freedom from local tumor progression is measured at 2 years, after being determined at 6 months.

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NCT01890590

A Phase II Study of Cyberknife Radiosurgery for Renal Cell Carcinoma

Recruiting
NAAges 18+InterventionalTreatment
Beth Israel Deaconess Medical Center
~46 participants
Updated 2024-08-15 on ClinicalTrials.gov
What's tested:CyberKnife

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
To determine the freedom from local tumor progression in patients treated with CyberKnife radiosurgery for primary renal tumors at 6 months
Measured over 2 Years

Conditions

Renal Cell Carcinoma

Explore related trials

Renal Cell Carcinoma

Where it's being run

1 sites across 1 states
Massachusetts1

Study leadership

  • Irving D Kaplan, MD · PRINCIPAL_INVESTIGATOR · Beth Israel Deaconess Medical Center

Who to contact

Irving D Kaplan, MD
[email protected]
617-667-2345
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • To determine the freedom from local tumor progression in patients treated with CyberKnife radiosurgery for primary renal tumors at 6 months2 Years

    To determine the freedom from local tumor progression in patients treated with CyberKnife radiosurgery for primary renal tumors at 6 months