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SuspendedNCT03575611Updated Oct 6, 2026

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

A Phase 2 interventional study of Biopsy and Biospecimen Collection in Metastatic Renal Cell Carcinoma and Stage IV Renal Cell Cancer AJCC v8, sponsored by M.D. Anderson Cancer Center. Suspended at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-06.

Sponsored by M.D. Anderson Cancer Center · Phase 2, Interventional, and Treatment

Why this study was suspended
PI Request
Phase
Phase 2
Study type
Interventional
Enrollment
123
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Metastatic Renal Cell Carcinoma
  • Stage IV Renal Cell Cancer AJCC v8
03

In context

Carcinoma, Renal Cell

1,965 studies on the registry are indexed under Carcinoma, Renal Cell; 378 are open to participants now.

This study's enrollment of 123 is above the median of 42 across 1,480 interventional studies indexed under Carcinoma, Renal Cell.

Browse Carcinoma, Renal Cell studies →

Lead sponsor

M.D. Anderson Cancer Center is the lead sponsor of 2,999 studies on the registry; 581 are open to participants now.

Of its 599 completed or terminated interventional studies of FDA-regulated products, 402 (67%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Receipt of > 1 line of systemic therapy directed towards the metastatic disease. This exclusion criteria will not apply for Cohort B, including the modified Cohort B definition

    • 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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
123 participants (actual)

Study arms

  • Experimental
    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.

    Procedure: Biopsy · Procedure: Biospecimen Collection · Procedure: Computed Tomography · Procedure: Magnetic Resonance Imaging · Procedure: Positron Emission Tomography · Radiation: Stereotactic Body Radiation Therapy

Interventions

  • ProcedureBiopsy

    Undergo tumor biopsy

    Also known as: BIOPSY_TYPE, Bx

  • ProcedureBiospecimen Collection

    Undergo blood sample collection

    Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection

  • ProcedureComputed Tomography

    Undergo CT and/or PET/CT

    Also known as: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized axial tomography (procedure), Computerized Tomography, Computerized Tomography (CT) scan, CT, CT Scan, tomography

  • ProcedureMagnetic Resonance Imaging

    Undergo MRI

    Also known as: 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

  • ProcedurePositron Emission Tomography

    Undergo PET/CT

    Also known as: 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

  • RadiationStereotactic Body Radiation Therapy

    Undergo SBRT

    Also known as: SABR, SBRT, Stereotactic Ablative Body Radiation Therapy

06

What researchers measure

Primary outcomes

  1. Feasibility of incorporating definitive radiation therapy (RT) (such as stereotactic body radiation therapy [SBRT]) into treatment plan for oligometastatic renal cell carcinoma (RCC) in lieu of systemic therapy

    Defined as successful completion of all protocol-related treatment with \< 7 days of unplanned radiation treatment delays within 3 years of protocol activation.

    Time frame: Up to 12 months

  2. Feasibility of incorporating definitive RT (such as SBRT) as a treatment strategy for low metastatic burden RCC in lieu of systemic therapy

    Defined as successful completion of all protocol-related treatment with \< 7 days of unplanned radiation treatment delays within 3 years of protocol approval.

    Time frame: Up to 12 months

  3. Progression-free survival (PFS) in oligometastatic RCC per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1

    Serial assessment with radiographic imaging will be evaluated. The probabilities of participants remaining alive and progression free will be estimated using the Kaplan Meier method with corresponding 95% confidence intervals.

    Time frame: At 12 months

  4. PFS in low metastatic burden RCC per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1

    Serial assessment with radiographic imaging will be evaluated. The probabilities of participants remaining alive and progression free will be estimated using the Kaplan Meier method with corresponding 95% confidence intervals.

    Time frame: Up to 12 months

Secondary outcomes

  1. Systemic therapy free survival

    The probabilities of patients remaining off systemic therapy at 12 months will be estimated utilizing the Kaplan Meier and model it as a function of potential prognostic factors using Cox proportional hazards regression.

    Time frame: At 12 months

  2. Reduction in cellular replication as measured by ki-67 staining (Cohort A)

    The number of cells with ki-67 staining per 10 high powered fields will be calculated in pre- and post SBRT samples. The percent difference in in ki-67 staining will be calculated by dividing the difference in pre- and post- ki67 staining by the pretreatment ki-67. Will estimate the median relative change with 95% confidence interval.

    Time frame: Baseline up to 12 months

  3. Overall survival

    The probabilities of participants remaining alive will be estimated utilizing the Kaplan Meier method with corresponding 95% confidence intervals.

    Time frame: At 12 months

  4. Freedom from new lesion development

    A participant will be considered to have a new lesion when standard radiographic imaging identifies a new lesion that is non-contiguous with any other lesions measured at baseline. The probabilities of patients remaining free from new lesions will be estimated utilizing the Kaplan Meier method with corresponding 95% confidence intervals.

    Time frame: At 12 months

  5. Treatment related toxicities associated with SBRT

    The frequency of grade 2 and higher toxicities attributable to study treatment will be reported for all patients at all follow up visits.

    Time frame: Up to 12 months

07

Study locations

1 site
  • M D Anderson Cancer Center
    Houston, Texas 77030, United States
08

References and documents

Publications

  • Tang C, Sherry AD, Seo A, Hara K, Choi H, Liu S, Sun X, Montoya A, Ludmir EB, Shah AY, Jonasch E, Zurita AJ, Kovitz C, Alhalabi O, Goswami S, Hahn AW, Campbell MT, Hernandez A, Nead KT, Van Loo P, Su S, Battey CJ, LaBella ML, Ratzel S, Acevedo A, Genovese G, Sircar K, Karam JA, Tannir NM, Msaouel P. Metastasis-directed radiotherapy without systemic therapy for oligometastatic clear-cell renal-cell carcinoma: primary efficacy analysis of a single-arm, single-centre, phase 2 trial. Lancet Oncol. 2025 Oct;26(10):1289-1299. doi: 10.1016/S1470-2045(25)00380-8. Epub 2025 Sep 4. PubMed 40915303 ↗
  • Tang C, Msaouel P, Hara K, Choi H, Le V, Shah AY, Wang J, Jonasch E, Choi S, Nguyen QN, Das P, Prajapati S, Yu Z, Khan K, Powell S, Murthy R, Sircar K, Tannir NM. Definitive radiotherapy in lieu of systemic therapy for oligometastatic renal cell carcinoma: a single-arm, single-centre, feasibility, phase 2 trial. Lancet Oncol. 2021 Dec;22(12):1732-1739. doi: 10.1016/S1470-2045(21)00528-3. Epub 2021 Oct 28. PubMed 34717797 ↗
09

Updates

1 registry update since Sep 25, 2026
Minor edits
Nothing that changes what the study is or who can join. Edited: verification date
1 update, last Oct 6, 2026
Show all 1 update
  1. Oct 6, 2026
    Minor edits only
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT03575611
Lead sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Jul 2, 2018
Start date
Jun 14, 2018
Primary completion
Aug 20, 2024
Completion
Sep 30, 2030 (estimated)
Last update
Oct 6, 2026

Study contacts

Chad Tang
principal investigator · M.D. Anderson Cancer Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is suspended, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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