Using CyberKnife to treat kidney cancer
A Phase II Study of Cyberknife Radiosurgery for Renal Cell Carcinoma
This study is testing whether a special type of radiation treatment called CyberKnife can help people with kidney cancer by targeting their tumors more accurately while protecting healthy tissue.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 46 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Beth Israel Deaconess Medical Center Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT01890590 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of CyberKnife radiosurgery in treating localized primary renal cell carcinoma. It involves a series of pre-treatment assessments, including medical history, imaging tests, and the placement of gold fiducials around the tumor to enhance targeting accuracy. Eligible participants will receive high doses of radiation specifically directed at their tumors while minimizing exposure to surrounding healthy tissues. The goal is to determine if this advanced radiation technique can improve treatment outcomes for patients with kidney cancer.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with Stage I renal cell carcinoma tumors no larger than 8 cm.
Not a fit: Patients with irreversible coagulopathies or other cancers may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a more effective treatment option for patients with localized renal cell carcinoma.
How similar studies have performed: Other studies have shown success with CyberKnife radiosurgery for various cancers, suggesting potential for effectiveness in renal cell carcinoma as well.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Boston, Massachusetts
- Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Irving D Kaplan, MD — Beth Israel Deaconess Medical Center
- Study coordinator: Irving D Kaplan, MD
- Email: ikaplan@caregroup.harvard.edu
- Phone: 617-667-2345
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.