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

Conditions

Metastatic Renal Cell Carcinoma, Stage IV Renal Cell Cancer AJCC v8

Brief 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.

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.

Chad Tang, A. Dean Sherry, Aaron Seo, Kieko Hara, Haesun Choi et al. (20 authors)

The Oncologist2025-10-01

10.1093/oncolo/oyaf276.008

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.

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.

2025-09-041 citations

10.1016/s1470-2045(25)00380-8

Abstract CT132: Phase 2 trial of metastasis directed radiotherapy without systemic therapy (MRWS) for oligometastatic clear cell renal cell carcinoma (ccRCC) and investigation of circulating tumor DNA (ctDNA) as a personalized biomarker

Chad Tang, Alexander D. Sherry, Aaron Seo, Kieko Hara, Haesun Choi et al. (20 authors)

Cancer Research2025-04-25

10.1158/1538-7445.am2025-ct132

Evaluation of immune exhaustion across the evolution of oligometastatic clear cell renal cell carcinoma using spatially resolved tissue immune profiling: Secondary analysis of a prospective trial.

Kieko Hara, Guillermo E. Corredor-Alonso, Alejandra G. Serrano, Sharia Hernandez, Wei Lü et al. (14 authors)

Journal of Clinical Oncology2023-02-20

10.1200/jco.2023.41.6_suppl.701

Definitive radiotherapy in lieu of systemic therapy for oligometastatic renal cell carcinoma: a single-arm, single-centre, feasibility, phase 2 trial.

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.

2021-10-28115 citations

10.1016/s1470-2045(21)00528-3

Interventions

PROCEDUREBiopsy

Undergo tumor biopsy

PROCEDUREBiospecimen Collection

Undergo blood sample collection

PROCEDUREComputed Tomography

Undergo CT and/or PET/CT

PROCEDUREMagnetic Resonance Imaging

Undergo MRI

PROCEDUREPositron Emission Tomography

Undergo PET/CT

RADIATIONStereotactic Body Radiation Therapy

Undergo SBRT

Study design

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

* Receipt of \> 1 line of systemic therapy directed towards the metastatic disease. This

Design outcomes

Primary

Measure	Time frame	Description
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	Up to 12 months	Defined as successful completion of all protocol-related treatment with \< 7 days of unplanned radiation treatment delays within 3 years of protocol activation.
Feasibility of incorporating definitive RT (such as SBRT) as a treatment strategy for low metastatic burden RCC in lieu of systemic therapy	Up to 12 months	Defined as successful completion of all protocol-related treatment with \< 7 days of unplanned radiation treatment delays within 3 years of protocol approval.
Progression-free survival (PFS) in oligometastatic RCC per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1	At 12 months	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.
PFS in low metastatic burden RCC per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1	Up to 12 months	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.

Secondary

Measure	Time frame	Description
Systemic therapy free survival	At 12 months	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.
Reduction in cellular replication as measured by ki-67 staining (Cohort A)	Baseline up to 12 months	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.
Overall survival	At 12 months	The probabilities of participants remaining alive will be estimated utilizing the Kaplan Meier method with corresponding 95% confidence intervals.
Freedom from new lesion development	At 12 months	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.
Treatment related toxicities associated with SBRT	Up to 12 months	The frequency of grade 2 and higher toxicities attributable to study treatment will be reported for all patients at all follow up visits.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORChad Tang

M.D. Anderson Cancer Center

Outcome results

None listed