Stereotactic Body Radiation Therapy in Treating Patients With Metastatic Kidney Cancer Undergoing Surgery

Stage IV Renal Cell Cancer Clinical Trial

Official title:

Immunologic Impact of Stereotactic Body Radiation Therapy (SBRT) in Renal Cell Carcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01892930
• Other study ID #: I 212712
• Secondary ID: NCI-2013-01201
• Status: Completed
• Phase: N/A
• Start date: July 11, 2013
• Est. completion date: December 30, 2016

Study information

• Verified date: July 2022
• Source: Roswell Park Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 directly to the tumor and cause less damage to normal tissue.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: December 30, 2016
• Est. primary completion date: December 30, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Renal Cell
• Recurrent Renal Cell Cancer
• Stage IV Renal Cell Cancer

Intervention

Radiation:
• stereotactic body radiation therapy
Undergo SBRT

Procedure:
• therapeutic conventional surgery
Undergo partial or radical nephrectomy

Other:
• laboratory biomarker analysis
Correlative studies

Locations

Country	Name	City	State
United States	Roswell Park Cancer Institute	Buffalo	New York

Sponsors (1)

Lead Sponsor	Collaborator
Roswell Park Cancer Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of conducting a partial nephrectomy in patients with no prior stereotactic radiation for kidney cancer		Up to 30 days post-treatment
Secondary	Toxicity analysis assessed by the CTEP Version 4 of the NCI Common Terminology Criteria for Adverse Events (CTCAE)		Up to 30 days post-treatment