Status:
COMPLETED
Stereotactic Body Radiation Therapy in Treating Patients With Metastatic Kidney Cancer Undergoing Surgery
Lead Sponsor:
Roswell Park Cancer Institute
Conditions:
Recurrent Renal Cell Cancer
Stage IV Renal Cell Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This pilot clinical trial studies stereotactic body radiation therapy in treating patients with metastatic kidney cancer undergoing surgery. Stereotactic radiation therapy may be able to send x-rays d...
Detailed Description
PRIMARY OBJECTIVES: I. Assess the impact of stereotactic body radiation therapy (SBRT) on the immune system in patients with metastatic renal cell carcinoma (RCC). SECONDARY OBJECTIVES: I. Assess c...
Eligibility Criteria
Inclusion
- Have metastatic RCC with primary tumor in place
- Must be surgical candidates as deemed fit by surgeon
- Have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria present
- Patients of child-bearing potential must agree to use adequate contraceptive methods (e.g., 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 she or her partner is participating in this study, she should inform her treating physician immediately
- Patient or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure
Exclusion
- Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Radiation to primary tumor prior to enrollment in this study
- Pregnant or nursing female patients
- Unwilling or unable to follow protocol requirements
- Any condition which in the Investigator's opinion deems the patient an unsuitable candidate to receive treatment
- Received an investigational agent within 30 days prior to enrollment
Key Trial Info
Start Date :
July 11 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2016
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT01892930
Start Date
July 11 2013
End Date
December 30 2016
Last Update
July 22 2022
Active Locations (1)
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1
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263