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

NCT ID: NCT01892930

Last Updated: 2022-07-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-07-11
• Study Completion Date: 2016-12-30

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.

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.

Conditions

Recurrent Renal Cell Cancer; Stage IV Renal Cell Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment (SBRT, nephrectomy)

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

Group Type: EXPERIMENTAL

stereotactic body radiation therapy

Intervention Type: RADIATION

Undergo SBRT

therapeutic conventional surgery

Intervention Type: PROCEDURE

Undergo partial or radical nephrectomy

laboratory biomarker analysis

Intervention Type: OTHER

Correlative studies

Interventions

stereotactic body radiation therapy

Undergo SBRT

Intervention Type: RADIATION

therapeutic conventional surgery

Undergo partial or radical nephrectomy

Intervention Type: PROCEDURE

laboratory biomarker analysis

Correlative studies

Intervention Type: OTHER

Other Intervention Names

SBRT; stereotactic radiation therapy; stereotactic radiotherapy

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Roswell Park Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thomas Schwaab

Role: PRINCIPAL_INVESTIGATOR

Roswell Park Cancer Institute

Locations

Roswell Park Cancer Institute

Buffalo, New York, United States

Countries

United States

References

Singh AK, Winslow TB, Kermany MH, Goritz V, Heit L, Miller A, Hoffend NC, Stein LC, Kumaraswamy LK, Warren GW, Bshara W, Odunsi K, Matsuzaki J, Abrams SI, Schwaab T, Muhitch JB. A Pilot Study of Stereotactic Body Radiation Therapy Combined with Cytoreductive Nephrectomy for Metastatic Renal Cell Carcinoma. Clin Cancer Res. 2017 Sep 1;23(17):5055-5065. doi: 10.1158/1078-0432.CCR-16-2946. Epub 2017 Jun 19.

Reference Type: DERIVED

PMID: 28630212 (View on PubMed)

Other Identifiers

NCI-2013-01201

Identifier Type: REGISTRY

Identifier Source: secondary_id

I 212712

Identifier Type: -

Identifier Source: org_study_id