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Radiation boost may stall spread in early metastatic cancers

NCT ID NCT03599765

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 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

Phase 2

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

Participants

380 people

The number who actually took part.

Started

Jul 2018

Expected to finish

Dec 2029

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: * 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

  • Banner MD Anderson Cancer Center

    Gilbert, Arizona, 85234, United States

  • Baptist Health Medical Center

    Little Rock, Arkansas, 72205, United States

  • Community Health Center

    Coldwater, Michigan, 49036, United States

  • Cooper Hospital University Medical Center

    Camden, New Jersey, 08103, United States

  • M D Anderson Cancer Center

    Houston, Texas, 77030, United States

  • MD Anderson League City

    Nassau Bay, Texas, 77058, United States

  • MD Anderson in Katy

    Houston, Texas, 77094, United States

  • MD Anderson in Sugar Land

    Sugar Land, Texas, 77478, United States

  • MD Anderson in The Woodlands

    The Woodlands, Texas, 77384, United States

  • OhioHealth Mansfield Hospital

    Mansfield, Ohio, 44903, United States

  • Queen's Medical Center

    Honolulu, Hawaii, 96813, United States

  • University of Texas Health Science Center at San Antonio

    San Antonio, Texas, 78229, United States

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