Study Stopped
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Stereotactic Body Radiation Therapy in Treating Patients With Oligometastatic Renal Cell Carcinoma
Definitive Radiation-Based Treatment Strategy for Oligometastatic and Low Metastatic Burden Renal Cell Carcinoma in Lieu of Systemic Therapy
3 other identifiers
interventional
123
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jun 2018
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 14, 2018
CompletedFirst Submitted
Initial submission to the registry
June 20, 2018
CompletedFirst Posted
Study publicly available on registry
July 2, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 20, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2030
ExpectedApril 15, 2026
April 1, 2026
6.2 years
June 20, 2018
April 10, 2026
Conditions
Outcome Measures
Primary Outcomes (4)
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.
Up to 12 months
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.
Up to 12 months
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.
At 12 months
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.
Up to 12 months
Secondary Outcomes (5)
Systemic therapy free survival
At 12 months
Reduction in cellular replication as measured by ki-67 staining (Cohort A)
Baseline up to 12 months
Overall survival
At 12 months
Freedom from new lesion development
At 12 months
Treatment related toxicities associated with SBRT
Up to 12 months
Study Arms (1)
Treatment (SBRT)
EXPERIMENTALPatients 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.
Interventions
Undergo blood sample collection
Undergo CT and/or PET/CT
Undergo MRI
Undergo PET/CT
Undergo SBRT
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- M.D. Anderson Cancer Centerlead
- National Cancer Institute (NCI)collaborator
Study Sites (1)
M D Anderson Cancer Center
Houston, Texas, 77030, United States
Related Publications (2)
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.
PMID: 40915303DERIVEDTang 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.
PMID: 34717797DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Chad Tang
M.D. Anderson Cancer Center
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 20, 2018
First Posted
July 2, 2018
Study Start
June 14, 2018
Primary Completion
August 20, 2024
Study Completion (Estimated)
September 30, 2030
Last Updated
April 15, 2026
Record last verified: 2026-04