Stereotactic Body Radiation Therapy in Treating Patients With Metastatic Kidney Cancer Undergoing Surgery
July 20, 2022 updated by: Roswell Park Cancer Institute
Immunologic Impact of Stereotactic Body Radiation Therapy (SBRT) in Renal Cell Carcinoma
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 directly to the tumor and cause less damage to normal tissue.
Study Overview
Status
Completed
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 changes in immune parameters prior to radiation, post radiation and post nephrectomy.
TERTIARY OBJECTIVES:
I. Assess surgical parameters for partial or radical nephrectomy post SBRT.
OUTLINE:
Patients undergo SBRT on day 1 and undergo partial or radical nephrectomy on day 29.
After completion of study treatment, patients are followed up at 30 days.
Study Type
Interventional
Enrollment (Actual)
15
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
Buffalo, New York, United States, 14263
- Roswell Park Cancer Institute
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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 Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Treatment (SBRT, nephrectomy)
Patients undergo SBRT on day 1 and undergo partial or radical nephrectomy on day 29.
|
Correlative studies
Undergo SBRT
Other Names:
Undergo partial or radical nephrectomy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Feasibility of conducting a partial nephrectomy in patients with no prior stereotactic radiation for kidney cancer
Time Frame: Up to 30 days post-treatment
|
Up to 30 days post-treatment
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Toxicity analysis assessed by the CTEP Version 4 of the NCI Common Terminology Criteria for Adverse Events (CTCAE)
Time Frame: Up to 30 days post-treatment
|
Up to 30 days post-treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Thomas Schwaab, Roswell Park Cancer Institute
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 11, 2013
Primary Completion (Actual)
December 30, 2015
Study Completion (Actual)
December 30, 2016
Study Registration Dates
First Submitted
June 20, 2013
First Submitted That Met QC Criteria
July 1, 2013
First Posted (Estimate)
July 8, 2013
Study Record Updates
Last Update Posted (Actual)
July 22, 2022
Last Update Submitted That Met QC Criteria
July 20, 2022
Last Verified
July 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- I 212712
- NCI-2013-01201 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.