Radiation may replace drugs for some kidney cancer patients
NCT ID NCT03575611
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase 2 trial tests whether high-precision radiation (SBRT) can control kidney cancer that has spread to a few spots in the body. The goal is to see if radiation alone can delay or replace the need for systemic drug therapy. The study involves 123 participants and includes biopsies and imaging before and after treatment.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- stereotactic body radiation therapy (SBRT)
- What this could lead to
- If successful, this approach could offer a way to control metastatic kidney cancer with radiation alone, potentially delaying or avoiding the need for systemic drug therapy.
- What could go wrong
- This is a small, early-phase trial that is currently suspended. It is unclear if radiation alone can effectively control the disease long-term, and not all patients may be suitable candidates.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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123 people
The number who actually took part.
- Started
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Jun 2018
- Expected to finish
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Sep 2030
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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M D Anderson Cancer Center
Houston, Texas, 77030, United States
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