Stereotactic Body Radiation Therapy in Treating Patients With Oligometastatic Renal Cell Carcinoma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Clinical Phase

PHASE2

Total Enrollment

123 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-14

Study Completion Date

2030-09-30

Brief Summary

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This phase II trial studies how well stereotactic body radiation therapy works in treating patients with kidney cancer that has spread to other places in the body (metastatic). Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method may kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue.

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Detailed Description

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PRIMARY OBJECTIVES:

I. To evaluate the feasibility definitive radiation therapy (RT) (such as stereotactic body radiation therapy \[SBRT\]) as a treatment strategy for oligometastatic renal cell carcinoma (RCC) in lieu of systemic therapy.

II. To estimate the progression free survival (PFS) after study enrollment utilizing a strategy of definitive local treatment to all sites of disease in oligometastatic and low metastatic burden RCC as measured by Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1).

III. To determine the systemic therapy free survival after study enrollment

SECONDARY OBJECTIVES:

I. To determine the effect of definitive RT (SBRT) on cellular replication and death, measured by ki-67 staining and others. (Required in Cohort A, but optional in Cohort B) II. To estimate the overall survival at 12 months after study enrollment. III. To estimate the freedom from new lesion development at 12 months. IV. To determine the treatment related toxicities associated with definitive RT as part of definitive local therapy for oligometastatic and low volume metastatic RCC.

EXPLORATORY OBJECTIVE:

I. To determine the association of translational biomarkers including peripheral blood markers and tissue markers with patient outcomes.

OUTLINE:

Patients undergo SBRT over 1 day to 3 weeks based on the judgment of the treating radiation oncologist. If the disease spreads to a new lesion that can be treated with local therapy, patients may repeat SBRT over 1 day to 3 weeks based on the judgment of the treating radiation oncologist. Patients may undergo blood sample collection throughout the trial, as well as a tumor biopsy on study. Patients also undergo computed tomography (CT), positron emission tomography (PET)/CT, and/or magnetic resonance imaging (MRI) throughout the trial.

After completion of study treatment, patients are followed up every 12 weeks for 1 year, and then every 18 weeks thereafter.

Conditions

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Metastatic Renal Cell Carcinoma Stage IV Renal Cell Cancer AJCC v8

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment (SBRT)

Patients undergo SBRT over 1 day to 3 weeks based on the judgment of the treating radiation oncologist. If the disease spreads to a new lesion that can be treated with local therapy, patients may repeat SBRT over 1 day to 3 weeks based on the judgment of the treating radiation oncologist. Patients may undergo blood sample collection throughout the trial, as well as a tumor biopsy on study. Patients also undergo CT, PET/CT, and/or MRI throughout the trial.

Group Type EXPERIMENTAL

Biopsy

Intervention Type PROCEDURE

Undergo tumor biopsy

Biospecimen Collection

Intervention Type PROCEDURE

Undergo blood sample collection

Computed Tomography

Intervention Type PROCEDURE

Undergo CT and/or PET/CT

Magnetic Resonance Imaging

Intervention Type PROCEDURE

Undergo MRI

Positron Emission Tomography

Intervention Type PROCEDURE

Undergo PET/CT

Stereotactic Body Radiation Therapy

Intervention Type RADIATION

Undergo SBRT

Interventions

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Biopsy

Undergo tumor biopsy

Intervention Type PROCEDURE

Biospecimen Collection

Undergo blood sample collection

Intervention Type PROCEDURE

Computed Tomography

Undergo CT and/or PET/CT

Intervention Type PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

Intervention Type PROCEDURE

Positron Emission Tomography

Undergo PET/CT

Intervention Type PROCEDURE

Stereotactic Body Radiation Therapy

Undergo SBRT

Intervention Type RADIATION

Other Intervention Names

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BIOPSY_TYPE Bx Biological Sample Collection Biospecimen Collected Specimen Collection CAT CAT Scan Computed Axial Tomography Computerized Axial Tomography Computerized axial tomography (procedure) Computerized Tomography Computerized Tomography (CT) scan CT CT Scan tomography Magnetic Resonance Magnetic Resonance Imaging (MRI) Magnetic resonance imaging (procedure) Magnetic Resonance Imaging Scan Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance MR MR Imaging MRI MRI Scan MRIs NMR Imaging NMRI Nuclear Magnetic Resonance Imaging sMRI Structural MRI Medical Imaging, Positron Emission Tomography PET PET Scan Positron emission tomography (procedure) Positron Emission Tomography Scan Positron-Emission Tomography proton magnetic resonance spectroscopic imaging PT SABR SBRT Stereotactic Ablative Body Radiation Therapy

Eligibility Criteria

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Inclusion Criteria

* Pathologically confirmed diagnosis of RCC of any histology.
* Be willing and able to undergo biopsy of a lesion planned for definitive RT (such as SBRT) both post treatment and pretreatment. If a lesion amenable to definitive RT was biopsied prior to enrollment, this material can be used in lieu of a planned biopsy if the tissue is available for review and ki-67 staining at MD Anderson.

* Patients may be allowed on this trial without a biopsy if they are deemed medically unfit for biopsy or if the biopsy poses undue risk in the opinion of the treating physician(s).
* Be \>= 18 years of age on the day of signing informed consent
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2.

* NOTE: If subject is unable to walk due to paralysis, but is mobile in a wheelchair, subject is considered to be ambulatory for the purpose of assessing their performance status.
* COHORT A: Oligometastatic RCC patients (=\< 5 metastatic lesions at the time of study entry).
* COHORT B: Patients eligible for Cohort A in addition to low volume metastatic patients. Low volume metastatic patients are defined as those with \> 5 metastatic lesions, but with =\< 5 metastatic lesions when excluding lesions \< 1 cm short axis and LNs \< 1 cm short axis
* Candidate for definitive local therapy to all sites of active disease per the discretion of the treating physicians
* Absolute neutrophil count (ANC) \>= 1,000 /mcL (within 6 weeks prior to study enrollment).
* Platelets \>= 50,000 / mcL (within 6 weeks prior to study enrollment).
* Hemoglobin \>= 9 g/dL or \>= 5.6 mmol/L (within 6 weeks prior to study enrollment).
* Serum total bilirubin =\< 1.5 mg//dl (except for subjects with Gilbert syndrome, who may have total bilirubin \< 3.0 mg/dl) OR direct bilirubin =\< ULN for subjects with total bilirubin levels \> 1.5 mg/dl (within 6 weeks prior to study enrollment).
* Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \[SGOT\]) and alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \[SGPT\]) =\< 3 X upper limit of normal ULN OR =\< 5 X ULN for subjects with liver metastases (within 6 weeks prior to study enrollment).
* At least one site which in the opinion of the treating radiation oncologist is treatable with definitive RT and can be biopsied

Exclusion Criteria

* Systemic therapy as a component of prior definitive therapy directed towards non-metastatic disease will be allowed. For example, patients receiving adjuvant interleukin (IL)-2 after nephrectomy for an initial M0 diagnosis and who subsequently developed metastatic relapse will be allowed on study. In this instance, there will be no mandatory wash-out period required for enrollment.
* At trial entry the patient must have received their last dose of systemic therapy (e.g. last intravenously \[IV\] administration of orally \[PO\] tablet/pill) 4 weeks prior to initiation of the first dose of radiation
* Has a diagnosis of active scleroderma, lupus, or other rheumatologic disease which in the opinion of the treating radiation oncologist precludes safe radiation therapy.
* Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial as determined by the treating physician and/or member of the study team.
* Metastatic effusion (e.g. pleural effusion or ascites). Note that patients with an effusion that is too small to sample will be eligible for the trial.
* Diffuse metastatic processes including leptomeningeal disease, diffuse bone marrow involvement, and peritoneal carcinomatous, which by the discretion of the treating physician cannot be treated definitively.
* Is pregnant or expecting to conceive within the projected duration of the trial at the screening visit.

* Female subject of childbearing potential should have a negative urine or serum pregnancy within 6 weeks prior to study registration up to the first fraction of radiation.
* Note: If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No