Radiation boost may stall spread in early metastatic cancers
NCT ID NCT03599765
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase II trial tests whether adding targeted radiation (local consolidative therapy) to standard systemic therapy can better control cancer that has spread to a few spots (oligometastatic disease). About 380 adults with solid tumors and up to 5 metastases are randomly assigned to receive standard therapy alone or with radiation. Researchers track side effects, cancer progression, new metastases, and survival.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Local Consolidative Therapy (radiation)
- What this could lead to
- If successful, this could show that adding targeted radiation to standard treatment helps delay cancer progression and improves survival for people with limited metastatic disease.
- What could go wrong
- This is a mid-stage trial with 380 participants, so results are not yet conclusive. The benefit may be small or not apply to all cancer types, and radiation carries risks like fatigue or local side effects.
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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380 people
The number who actually took part.
- Started
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Jul 2018
- Expected to finish
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Dec 2029
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: * Oligometastatic solid tumors (see protocol for relevant disease sites) patients (=\< 5 metastatic lesions at the time of study entry) * Candidate for definitive local therapy to all sites of active disease per the discretion of the treating physicians * No more than 4 prior lines of systemic therapy administered to treat metastatic disease * Pathologically confirmed diagnosis of cancer as specified in protocol * Eastern Cooperative Oncology Group (ECOG) performance status 0-2 * Absolute neutrophil count (ANC) \>= 500/mcL (performed within 6 weeks prior to study enrollment) * Platelets \>= 25,000/mcL (performed within 6 weeks prior to study enrollment) * Hemoglobin \>=7 g/dL (performed 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 =\< upper limit normal (ULN) for subjects with total bilirubin levels \> 1.5 mg/dl (performed 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 ULN OR =\< 5 X ULN for subjects with liver metastases (performed within 6 weeks prior to study enrollment) Exclusion Criteria: * Has a diagnosis of active scleroderma, lupus, or other rheumatologic disease which in the opinion of the treating radiation oncologist precludes safe radiation therapy * 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 * Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial * In the event that a curative systemic option exists for metastatic disease from a given disease site. First-line metastatic patients (those patients who have had no prior lines of systemic therapy targeting their metastatic disease) are only eligible for enrollment if they have completed their curative systemic therapy per the judgment of the treating oncologist and have persistent disease * 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 * Additional diagnosis of another primary malignancy outside of the malignancy being treated on trial that per the discretion of the treating physicians and investigational team offers a substantial risk to the patient's life (e.g. primary lung cancer definitively treated in the past 6 months would offer a significant risk to the patient's life, while a basal cell carcinoma treated with local excision would not)
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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
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Banner MD Anderson Cancer Center
Gilbert, Arizona, 85234, United States
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Baptist Health Medical Center
Little Rock, Arkansas, 72205, United States
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Community Health Center
Coldwater, Michigan, 49036, United States
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Cooper Hospital University Medical Center
Camden, New Jersey, 08103, United States
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M D Anderson Cancer Center
Houston, Texas, 77030, United States
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MD Anderson League City
Nassau Bay, Texas, 77058, United States
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MD Anderson in Katy
Houston, Texas, 77094, United States
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MD Anderson in Sugar Land
Sugar Land, Texas, 77478, United States
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MD Anderson in The Woodlands
The Woodlands, Texas, 77384, United States
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OhioHealth Mansfield Hospital
Mansfield, Ohio, 44903, United States
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Queen's Medical Center
Honolulu, Hawaii, 96813, United States
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University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229, United States
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