Status:
RECRUITING
A Phase II Study of Cyberknife Radiosurgery for Renal Cell Carcinoma
Lead Sponsor:
Beth Israel Deaconess Medical Center
Collaborating Sponsors:
Dana-Farber Cancer Institute
Conditions:
Renal Cell Carcinoma
Eligibility:
All Genders
18+ years
Phase:
NA
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 ...
Detailed Description
Before the research starts (screening) Many of these tests and procedures are likely to be part of regular cancer care and may be done even if it turns out that you do not take part in the research st...
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
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2025
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT01890590
Start Date
July 1 2013
End Date
March 1 2025
Last Update
August 15 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215