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New radiation approach targets multiple tumors at once in early trial

NCT ID NCT02206334

Knowledge-focused Sponsor: NRG Oncology Source: ClinicalTrials.gov ↗

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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This early-phase trial tested a precise, high-dose radiation technique called stereotactic body radiotherapy (SBRT) in 42 patients with breast, lung, or prostate cancer that had spread to several places in the body. The main goal was to find the safest dose and check for side effects when treating multiple tumor sites at the same time. The study did not aim to cure or control the disease, but to gather safety information for future research.

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 could help determine safe radiation doses for treating multiple cancer spread sites at once, potentially improving treatment options.
What could go wrong
This is an early phase 1 trial with only 42 participants, focused on safety and dosing, not effectiveness. Results may not apply to all patients or cancer types.

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 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

42 people

The number who actually took part.

Started

Aug 2014

Finished

May 2022

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: * Metastatic breast cancer (MBC) OR metastatic non-small cell lung cancer (NSCLC) OR metastatic adenocarcinoma of the prostate; the sites of allowed metastases are: peripheral lung, central lung, mediastinal/cervical lymph node, liver, spinal/paraspinal, osseous, and abdominal-pelvic * NOTE: after the required number of evaluable patients have been accrued for a given dose level, the accrual for that metastatic location will be temporarily suspended while the safety of that dose level is assessed; a patient can only be entered onto the trial if all of their metastatic locations are open to accrual (e.g. if central lung is temporarily suspended for safety assessment and the patient has a central lung metastases, regardless of other metastases, they cannot enroll until the safety of dose to central lung is determined) * Primary tumor site without progression at registration * All metastases not resected must be amenable to SBRT * The patient must meet ONE of the three following criteria: * 3-4 radiographically distinct metastases of any distribution in the allowed anatomical sites OR * 2 radiographically distinct metastases that must be anatomically close (i.e., with less than or equal to 5 cm of normal tissue between them) OR * 3 or 4 distinct metastasis, 2 or 3 to be treated with SBRT and the other (s) having been surgically removed * Evaluation by a radiation oncologist within 45 days prior to study registration * Evaluation by a medical oncologist within 45 days prior to study registration * The following imaging workup to document metastases within 45 days prior to study registration: * Computed tomography (CT) scans of the chest, abdomen and pelvis with radionuclide bone scan OR whole body positron emission tomography (PET)/CT * History/physical examination within 45 days prior to study registration * Zubrod performance status =\< 2 within 45 days prior to study registration * Age \>= 18 years * Absolute neutrophil count (ANC) \>= 500 cells/mm\^3 * Platelets \>= 50,000 /mm\^3 * Hemoglobin \>= 8.0 g/dl (Note: the use of transfusion or other intervention to achieve hemoglobin \[Hgb\] \>= 8.0 g/dl is acceptable) * If liver metastases present, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) must be \< 3 x upper limit of normal (ULN) * Patient must provide study specific informed consent prior to study entry * For females of child-bearing potential, negative serum/urine pregnancy test within 14 days prior to study registration Exclusion Criteria: * Progression of primary tumor site (breast, prostate, or lung) at time of registration * Metastases with indistinct borders making targeting not feasible * Known brain metastases * Prior palliative radiotherapy to metastases * Metastases located within 3 cm of the previously irradiated structures: * Spinal cord previously irradiated to \> 40 Gy (delivered in =\< 3 Gy/fraction) * Brachial plexus previously irradiated to \> 50 Gy (delivered in =\< 3 Gy/fraction) * Small intestine, large intestine, or stomach previously irradiated to \> 45 Gy (delivered in =\< 3 Gy/fraction) * Brain stem previously irradiated to \> 50 Gy (delivered in =\< 3 Gy/fraction) * Whole lung previously irradiated with prior volume 20 Gy (V20Gy) \> 30% (delivered in =\< 3 Gy/fraction) * Primary tumor irradiated with SBRT * Metastasis irradiated with SBRT * Severe, active co-morbidity, defined as follows: * Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months prior to registration * Transmural myocardial infarction within the last 6 months prior to registration * Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration * Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days prior to registration * Severe hepatic disease, defined as a diagnosis of Child-Pugh class B or C hepatic disease * Human immunodeficiency virus (HIV) positive with cluster of differentiation (CD) 4 count \< 200 cells/microliter; note that patients who are HIV positive are eligible, provided they are under treatment with highly active antiretroviral therapy (HAART) and have a CD4 count \>= 200 cells/microliter within 30 days prior to registration; note also that HIV testing is not required for eligibility for this protocol * End-stage renal disease (i.e., on dialysis or dialysis has been recommended) * Pregnancy or women of childbearing potential not willing/able to use medically acceptable forms of contraception during protocol treatment or for at least 6 months following treatment

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Conditions

The condition(s) this trial relates to.

breast cancer breast carcinoma breast neoplasm male breast carcinoma metastatic prostate carcinoma non-small cell lung carcinoma prostate adenocarcinoma prostate cancer prostate carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Male breast carcinoma Prostate adenocarcinoma Recurrent breast carcinoma Recurrent non-small cell lung carcinoma Recurrent prostate carcinoma Stage IV breast cancer Stage IV non-small cell lung cancer Stage IV prostate cancer

Contacts and locations

Locations

  • Arizona Center for Cancer Care-Peoria

    Peoria, Arizona, 85381, United States

  • Ascension Saint Vincent Anderson

    Anderson, Indiana, 46016, United States

  • Ascension Via Christi Hospitals Wichita

    Wichita, Kansas, 67214, United States

  • Banner University Medical Center - Tucson

    Tucson, Arizona, 85719, United States

  • Boston Medical Center

    Boston, Massachusetts, 02118, United States

  • CHUM - Centre Hospitalier de l'Universite de Montreal

    Montreal, Quebec, H2X 3E4, Canada

  • City of Hope Comprehensive Cancer Center

    Duarte, California, 91010, United States

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195, United States

  • Community Medical Center

    Toms River, New Jersey, 08755, United States

  • Cooper CyberKnife Center

    Mount Laurel, New Jersey, 08054, United States

  • Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2, Canada

  • Decatur Memorial Hospital

    Decatur, Illinois, 62526, United States

  • Delaware County Memorial Hospital

    Drexel Hill, Pennsylvania, 19026, United States

  • Duke University Medical Center

    Durham, North Carolina, 27710, United States

  • Emory University Hospital Midtown

    Atlanta, Georgia, 30308, United States

  • Emory University Hospital/Winship Cancer Institute

    Atlanta, Georgia, 30322, United States

  • Grady Health System

    Atlanta, Georgia, 30303, United States

  • Gundersen Lutheran Medical Center

    La Crosse, Wisconsin, 54601, United States

  • Henry Ford Hospital

    Detroit, Michigan, 48202, United States

  • Henry Ford West Bloomfield Hospital

    West Bloomfield, Michigan, 48322, United States

  • Huntsman Cancer Institute/University of Utah

    Salt Lake City, Utah, 84112, United States

  • IU Health Methodist Hospital

    Indianapolis, Indiana, 46202, United States

  • Iowa Methodist Medical Center

    Des Moines, Iowa, 50309, United States

  • Jewish General Hospital

    Montreal, Quebec, H3T 1E2, Canada

  • Kantonsspital Aarau

    Aarau, 5001, Switzerland

  • Legacy Good Samaritan Hospital and Medical Center

    Portland, Oregon, 97210, United States

  • Loyola University Medical Center

    Maywood, Illinois, 60153, United States

  • Mayo Clinic in Rochester

    Rochester, Minnesota, 55905, United States

  • McLaren Cancer Institute-Flint

    Flint, Michigan, 48532, United States

  • McLaren Cancer Institute-Macomb

    Mount Clemens, Michigan, 48043, United States

  • McLaren Cancer Institute-Northern Michigan

    Petoskey, Michigan, 49770, United States

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226, United States

  • Medical University of South Carolina

    Charleston, South Carolina, 29425, United States

  • Mercy Hospital

    Coon Rapids, Minnesota, 55433, United States

  • Michigan Healthcare Professionals Clarkston

    Clarkston, Michigan, 48346, United States

  • Michigan Healthcare Professionals Farmington

    Farmington Hills, Michigan, 48334, United States

  • Michigan Healthcare Professionals Troy

    Troy, Michigan, 48098, United States

  • Montefiore Medical Center - Moses Campus

    The Bronx, New York, 10467, United States

  • Northwell Health/Center for Advanced Medicine

    Lake Success, New York, 11042, United States

  • Northwest Community Hospital

    Arlington Heights, Illinois, 60005, United States

  • Northwestern University

    Chicago, Illinois, 60611, United States

  • OSF Saint Francis Medical Center

    Peoria, Illinois, 61637, United States

  • Ogden Regional Medical Center

    Ogden, Utah, 84405, United States

  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210, United States

  • Parkview Hospital Randallia

    Fort Wayne, Indiana, 46805, United States

  • Poudre Valley Hospital

    Fort Collins, Colorado, 80524, United States

  • Reading Hospital

    West Reading, Pennsylvania, 19611, United States

  • Self Regional Healthcare

    Greenwood, South Carolina, 29646, United States

  • Southwest Illinois Health Services LLP

    Swansea, Illinois, 62226, United States

  • Springfield Memorial Hospital

    Springfield, Illinois, 62781, United States

  • Sutter Medical Center Sacramento

    Sacramento, California, 95816, United States

  • The James Graham Brown Cancer Center at University of Louisville

    Louisville, Kentucky, 40202, United States

  • Trinity Health Saint Joseph Mercy Oakland Hospital

    Pontiac, Michigan, 48341, United States

  • UC San Diego Moores Cancer Center

    La Jolla, California, 92093, United States

  • UCHealth University of Colorado Hospital

    Aurora, Colorado, 80045, United States

  • UF Health Cancer Institute - Gainesville

    Gainesville, Florida, 32610, United States

  • UM Upper Chesapeake Medical Center

    Bel Air, Maryland, 21014, United States

  • USC / Norris Comprehensive Cancer Center

    Los Angeles, California, 90033, United States

  • University of Alabama at Birmingham Cancer Center

    Birmingham, Alabama, 35233, United States

  • University of California Davis Comprehensive Cancer Center

    Sacramento, California, 95817, United States

  • University of Chicago Comprehensive Cancer Center

    Chicago, Illinois, 60637, United States

  • University of Cincinnati Cancer Center-UC Medical Center

    Cincinnati, Ohio, 45219, United States

  • University of Cincinnati Cancer Center-West Chester

    West Chester, Ohio, 45069, United States

  • University of Florida Health Science Center - Jacksonville

    Jacksonville, Florida, 32209, United States

  • University of Iowa/Holden Comprehensive Cancer Center

    Iowa City, Iowa, 52242, United States

  • University of Kentucky/Markey Cancer Center

    Lexington, Kentucky, 40536, United States

  • University of Maryland/Greenebaum Cancer Center

    Baltimore, Maryland, 21201, United States

  • University of Miami Miller School of Medicine-Sylvester Cancer Center

    Miami, Florida, 33136, United States

  • University of Michigan Rogel Cancer Center

    Ann Arbor, Michigan, 48109, United States

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198, United States

  • University of New Mexico Cancer Center

    Albuquerque, New Mexico, 87106, United States

  • University of Rochester

    Rochester, New York, 14642, United States

  • Virtua Memorial

    Mount Holly, New Jersey, 08060, United States

  • Virtua Voorhees

    Voorhees Township, New Jersey, 08043, United States

  • Wake Forest University Health Sciences

    Winston-Salem, North Carolina, 27157, United States

  • Walter Reed National Military Medical Center

    Bethesda, Maryland, 20889-5600, United States

  • Washington University School of Medicine

    St Louis, Missouri, 63110, United States

  • Zablocki Veterans Administration Medical Center

    Milwaukee, Wisconsin, 53295, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.