Can zapping cancer spots with Super-Precise radiation delay the disease?
NCT ID NCT03808337
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether giving a very focused, high-dose radiation treatment (SBRT) to all visible cancer spots can delay the cancer from getting worse in people with breast or lung cancer that has spread to 1-5 places. About 145 participants will either receive standard care alone or standard care plus SBRT to each metastasis. The goal is to see if the radiation helps keep the disease under control longer.
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 radiotherapy (SBRT) – a precise, high-dose radiation treatment
- What this could lead to
- If it works, this could show that targeting all visible cancer spots with radiation helps keep the disease from getting worse for longer, potentially improving control of metastatic cancer.
- What could go wrong
- This is a mid-stage trial with only 145 participants, so results may not apply to everyone. SBRT can cause side effects like fatigue or damage to nearby organs, and it may not improve survival or prevent new metastases.
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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About 145 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2019
- Expected to finish
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Jan 2027
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: * Metastatic disease detected on imaging and histologically confirmed * Metastatic breast cancer (all subtypes) * Non-small cell lung cancer (NSCLC) without known targetable molecular alterations in EGFR, ALK, or ROS1 * NSCLC with EGFR, ALK, or ROS1 targetable molecular alterations who had a history of disease progression on first-line tyrosine kinase inhibitor * Patient can either have newly diagnosed metastatic disease, or have non-progressive disease on systemic therapy (for at least 3 months on systemic imaging) * Patients must have measurable disease at baseline (RECIST or PERCIST 2.0) and with 5 or fewer discrete disease sites that are technically amendable to SBRT (with the exception that if the primary disease is not amendable to SBRT it is allowed to be treated with conventionally fractionated or hypfractionated radiotherapy). * Two lesions in such close proximity to one another that treatment with one isocenter is more accurate and safer in the liver, lungs, or other similar anatomic locations should be viewed as one site of metastatic disease treatment * Disease in 2 contiguous vertebral bodies (with up to 6 cm of paraspinal extension) can represent one site of disease in the spine; non-contiguous lesions in vertebral bodies separated by one vertebral body free of disease should be viewed as 2 sites of treatment * If the clinical scenario deem that other forms of local therapy may be more suitable for the metastatic disease, such as surgical resection and interventional radiology-guided ablation, patients would be able to undergo other forms of local therapy with discussion with the PI. * For de novo stage IV patients (patients with metastatic disease at first presentation), primary disease must be treatable with local therapy. If the primary tumor or other locoregional disease has not been definitively treated and is not amendable to SBRT, it must be treated with conventionally fractionated or hypofractionated radiotherapy using a regimen that delivers a minimum BED of 48 Gy10. If the clinical scenario deem that other forms of local therapy may be more suitable for the primary and locoregional disease, such as surgical resection and interventional radiology-guided ablation, patients would be able to undergo other forms of local therapy with discussion with the PI. * If primary disease was previously treated with local therapy in the form of surgery or radiation, any new local/regional disease recurrence should be technically treatable with SBRT or hypofractionated radiation. If the clinical scenario deem that other forms of local therapy may be more suitable for the local/regional recurrent disease, such as surgical resection and interventional radiology-guided ablation, patients would be able to undergo other forms of local therapy with discussion with the PI. * Patients may receive palliative radiotherapy for symptomatic metastases or primary disease prior to enrollment provided that there is at least one other non-irradiated lesion amenable to SBRT at the time of enrollment. * Patients with brain metastases are eligible if these lesions have been treated prior to enrollment. * ECOG Performance status 0 - 2. * Age \>/= 18 years. * Able to provide informed consent. * Female subjects must either be of non-reproductive potential (i.e. post-menopausal by history: \>/= 60 years old or no menses for 1\> year without an alternative medical cause; OR history of hysterectomy, OR history of bilateral tubal ligation, OR history of bilateral oophorectomy) or must have a negative serum pregnancy test within 2 weeks prior to starting treatment. * Adequate baseline organ function to allow SBRT to all relevant targets, as determined by the treating radiation oncologist based on lesion location, lesion size, and proximity to relevant organs at risk. Exclusion Criteria: * Serious medical co-morbidities precluding radiotherapy, determined at the discretion of the treating investigator. * Pregnant or lactating women. * Other active malignancy within the last year, even if without evidence of disease. * Clinical or radiological evidence of spinal cord compression * Malignant pleural effusion or ascites. * Patients whose entry to the trial will cause unacceptable clinical delays in their planned management.
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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
12 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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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Baptist Alliance - McI
RECRUITINGMiami, Florida, 33143, United States
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Hartford Healthcare
RECRUITINGHartford, Connecticut, 06102, United States
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Lehigh Valley Health Network
RECRUITINGAllentown, Pennsylvania, 18103, United States
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Memorial Sloan Kettering Basking Ridge
RECRUITINGBasking Ridge, New Jersey, 07920, United States
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Memorial Sloan Kettering Bergen
RECRUITINGMontvale, New Jersey, 07645, United States
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Memorial Sloan Kettering Cancer Center
RECRUITINGNew York, New York, 10065, United States
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Memorial Sloan Kettering Cancer Center @ Commack
RECRUITINGCommack, New York, 11725, United States
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Memorial Sloan Kettering Monmouth
RECRUITINGMiddletown, New Jersey, 07748, United States
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Memorial Sloan Kettering Nassau
RECRUITINGUniondale, New York, 11553, United States
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Memorial Sloan Kettering Westchester
RECRUITINGHarrison, New York, 10604, United States
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Natera, Inc. (Data and Specimen Analysis Only)
NOT_YET_RECRUITINGSan Carlos, California, 94070, United States
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WCHN Norwalk Hospital - Data Collection
RECRUITINGNorwalk, Connecticut, 06850, United States
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