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Can a precise radiation burst stall Cancer's spread?

NCT ID NCT03808662

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether giving stereotactic body radiotherapy (SBRT) to growing metastatic tumors can delay overall cancer progression. About 107 adults with triple-negative breast cancer or non-small cell lung cancer that has started to grow in a few spots will receive SBRT or no immediate radiation. The goal is to see if early, precise radiation can buy more time before the disease gets worse.

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)
What this could lead to
If it works, this could give patients more time before their cancer progresses, potentially delaying the need for stronger treatments.
What could go wrong
This is a mid-stage trial with only 107 participants, so results may not apply to everyone. SBRT can cause side effects like fatigue or damage to nearby organs.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

107 people

The number who actually took part.

Started

Jan 2019

Expected to finish

Jan 2027

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Age 18 or older * Willing and able to provide informed consent * Metastatic disease detected on imaging and histologically confirmed: Triple negative breast cancer TNBC (ER \<1%, PR \<1%, her-2-neu 0- 1+ by IHC or FISH-negative or as determined by MD discretion) OR NSCLC (without known EGFR mutation or ALK/ROS1 rearrangement) OR Other high-risk breast cancer (per physician's discretion) progressed on hormone or systemic therapy, regardless of ER/HER2 status OR NSCLC with EGFR, ALK, or ROS1 targetable molecular alterations with disease progression on first-line tyrosine kinase inhibitor Note: * Biopsy of metastasis prior to enrollment is per treating physician's discretion per standard of care. It is preferred but not required. * These patients are selected for the study given the similar survival outcomes when given standard of care therapies * Patient has received at least first-line prior treatment with systemic therapy (either cytotoxic or targeted, including maintenance therapies). * Patients who received prior immunotherapy are allowed. * Patients who had any prior radiation therapy near or overlapping with the oligoprogressive sites are allowed to enroll. * Patients with the following medical conditions precluding them from participating in other systemic therapy or drug trials are allowed: * active liver disease, including viral or other hepatitis, or cirrhosis * any other significant medical condition not under control, including any acute coronary syndrome within the past 6 months. * a permanent pacemaker * a QTc \> 480 ms in the baseline EKG * peripheral neuropathy of grade \>/= 2 per NCI CTCAE * history or known autoimmune disease * current chronic systemic steroid therapy or any immunosuppressive therapy * history of primary immunodeficiency or solid organ transplant * known positive human immunodeficiency virus (HIV), chronic or active hepatitis B or C, or active hepatitis A * active infection requiring systemic antibiotic therapy * Patients can have more than 5 metastases but can only have 1-5 oligo-progressive lesions. * Oligoprogression, defined as Response Evaluation Criteria in Solid Tumors (RECIST) or Positron Emission Tomography Response Criteria in Solid Tumors (PERCIST) documented progression in up to 5 individual lesions Using Response Evaluation Criteria in Solid Tumors (RECIST) Criteria as a guide: 1. At least a 20% increase in the sum of the longest diameter (LD) of the lesion, taking as reference the smallest sum LD recorded since the last imaging OR 2. The appearance of one or more new lesions OR 3. New/malignant FDG uptake in the absence of other indications of progressive disease or an anatomically stable lesion OR 4. \>/= 5mm increase in the diameter sum of the lesion OR Using Positron Emission Tomography Response Criteria in Solid Tumors (PERCIST) as a guide: 1. \>30% increase in 18F-FDG SUV peak, with \>0.8 SUV units increase in tumor SUV from the baseline scan in pattern typical of tumor and not of infection/treatment effect OR 2. Visible increase in the extent of 18F-FDG tumor uptake OR 3. New 18F-FDG avid lesions typical of cancer (including new bone lesion) and not related to treatment effect and/or infection OR Development of a new soft tissue metastatic lesion at least 5mm in size or any new bone metastasis OR Progressive enlargement of a known metastasis on 2 consecutive imaging studies at least 2 months apart with a minimum 5mm increase in size * All sites of oligoprogression can be safely treated * Maximum 5 progressing metastases in any single extra-cranial organ system (i.e. lung, liver, bone) a. 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 * No restriction on the total number of metastases * Note: 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 patients with brain metastases and oligoprogression elsewhere where stereotactic radiation to the brain is warranted, the brain lesions can be treated prior to randomization. This will not be counted toward the 5 progressive lesions. * Any symptomatic metastatic sites requiring prompt palliative radiation (e.g. cord compression) can also be treated with standard of care radiation prior to randomization. This will not be counted toward the 5 progressive lesions. 1. 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. Exclusion Criteria: * Pregnancy. * Leptomeningeal disease. * Serious medical comorbidities precluding radiotherapy, such as ataxia-telangiectasia or scleroderma. * Any other condition which in the judgment of the investigator would make the patient inappropriate for entry into this study.

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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.

Contacts and locations

Locations

  • Fred Hutchinson Cancer Research Center (Data Analysis Only)

    Seattle, Washington, 98109, United States

  • Memorial Sloan Kettering Basking Ridge

    Basking Ridge, New Jersey, 07920, United States

  • Memorial Sloan Kettering Bergen

    Montvale, New Jersey, 07645, United States

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065, United States

  • Memorial Sloan Kettering Commack

    Commack, New York, 11725, United States

  • Memorial Sloan Kettering Monmouth

    Middletown, New Jersey, 07748, United States

  • Memorial Sloan Kettering Nassau

    Uniondale, New York, 11553, United States

  • Memorial Sloan Kettering Rockville Centre

    Rockville Centre, New York, 11570, United States

  • Memorial Sloan Kettering Westchester

    Harrison, New York, 10604, United States

  • Princess Margaret Hospital/Ontario Cancer Institute (Data Analysis Only)

    Toronto, Ontario, Canada

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