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

Sponsor
Roswell Park Cancer Institute (Other)
Overall Status
Completed
CT.gov ID
NCT01892930
Collaborator
(none)
15
Enrollment
1
Location
1
Arm
41.7
Actual Duration (Months)
0.4
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Radiation: stereotactic body radiation therapy
  • Procedure: therapeutic conventional surgery
  • Other: laboratory biomarker analysis
 N/A

Detailed Description

PRIMARY OBJECTIVES:
  1. Assess the impact of stereotactic body radiation therapy (SBRT) on the immune system in patients with metastatic renal cell carcinoma (RCC).
SECONDARY OBJECTIVES:
  1. Assess changes in immune parameters prior to radiation, post radiation and post nephrectomy.
TERTIARY OBJECTIVES:
  1. 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 Design

Study Type:
Interventional
Actual Enrollment :
15 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Immunologic Impact of Stereotactic Body Radiation Therapy (SBRT) in Renal Cell Carcinoma
Actual Study Start Date :
Jul 11, 2013
Actual Primary Completion Date :
Dec 30, 2015
Actual Study Completion Date :
Dec 30, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: Treatment (SBRT, nephrectomy)

Patients undergo SBRT on day 1 and undergo partial or radical nephrectomy on day 29.

Radiation: stereotactic body radiation therapy
Undergo SBRT
Other Names:
  • SBRT
  • stereotactic radiation therapy
  • stereotactic radiotherapy

    • Procedure: therapeutic conventional surgery
    Undergo partial or radical nephrectomy

    Other: laboratory biomarker analysis
    Correlative studies

    Outcome Measures

    Primary Outcome Measures

    1. Feasibility of conducting a partial nephrectomy in patients with no prior stereotactic radiation for kidney cancer [Up to 30 days post-treatment]

    Secondary Outcome Measures

    1. Toxicity analysis assessed by the CTEP Version 4 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) [Up to 30 days post-treatment]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Roswell Park Cancer Institute Buffalo New York United States 14263

    Sponsors and Collaborators

    • Roswell Park Cancer Institute

    Investigators

    • Principal Investigator: Thomas Schwaab, Roswell Park Cancer Institute

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Roswell Park Cancer Institute
    ClinicalTrials.gov Identifier:
    NCT01892930
    Other Study ID Numbers:
    • I 212712
    • NCI-2013-01201
    First Posted:
    Jul 8, 2013
    Last Update Posted:
    Jul 22, 2022
    Last Verified:
    Jul 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Carcinoma, Renal Cell

    Study Results

    No Results Posted as of Jul 22, 2022