Stereotactic Body Radiation Therapy in Treating Patients With Metastatic Breast Cancer, Non-small Cell Lung Cancer, or Prostate Cancer
NCT ID: NCT02206334
Last Updated: 2022-05-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
42 participants
INTERVENTIONAL
2014-08-31
2022-05-20
Brief Summary
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Detailed Description
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I. To determine the recommended stereotactic body radiation therapy (SBRT) dose for each of the metastatic locations being treated given the individual and overlapping fields when multiple metastases are treated with SBRT in a national clinical trials network setting.
SECONDARY OBJECTIVES:
I. To estimate rates of \>= grade 3 Common Terminology Criteria for Adverse Events (CTCAE), version (v.) 4.0 adverse events other than a dose-limiting toxicity (DLT) which is possibly, probably, or definitely related to treatment and which occurs within 6 months from the start of SBRT to multiple metastases.
II. To estimate the rates of long-term adverse events occurring up to 2 years from the end of SBRT.
III. To explore the most appropriate and clinically relevant technological parameters to ensure quality and effectiveness throughout radiation therapy processes, including imaging, simulation, patient immobilization, target and critical structure definition, treatment planning, image guidance and delivery.
OUTLINE:
Patients undergo 3-5 fractions of image-guided stereotactic body radiation therapy to all existing metastases over 1-3 weeks with at least 40 hours between treatments for an individual metastasis.
After completion of study treatment, patients are followed up at 35-45 days and then every 3 months for 2 years.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Stereotactic Body Radiation Therapy (SBRT)
Patients undergo 3-5 fractions of image-guided stereotactic body radiation therapy to all existing metastases over 1-3 weeks with at least 40 hours between treatments for an individual metastasis.
Stereotactic Body Radiation Therapy (SBRT)
Undergo SBRT
Interventions
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Stereotactic Body Radiation Therapy (SBRT)
Undergo SBRT
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
NRG Oncology
OTHER
Responsible Party
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Principal Investigators
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Steven Chmura
Role: PRINCIPAL_INVESTIGATOR
NRG Oncology
Locations
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University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, United States
Arizona Center for Cancer Care-Peoria
Peoria, Arizona, United States
Banner University Medical Center - Tucson
Tucson, Arizona, United States
City of Hope Comprehensive Cancer Center
Duarte, California, United States
UC San Diego Moores Cancer Center
La Jolla, California, United States
USC / Norris Comprehensive Cancer Center
Los Angeles, California, United States
Sutter Medical Center Sacramento
Sacramento, California, United States
University of California Davis Comprehensive Cancer Center
Sacramento, California, United States
University of Colorado Hospital
Aurora, Colorado, United States
Poudre Valley Hospital
Fort Collins, Colorado, United States
University of Florida Health Science Center - Gainesville
Gainesville, Florida, United States
University of Florida Health Science Center - Jacksonville
Jacksonville, Florida, United States
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, United States
Grady Health System
Atlanta, Georgia, United States
Emory University Hospital Midtown
Atlanta, Georgia, United States
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, United States
Northwest Community Hospital
Arlington Heights, Illinois, United States
Northwestern University
Chicago, Illinois, United States
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, United States
Decatur Memorial Hospital
Decatur, Illinois, United States
Loyola University Medical Center
Maywood, Illinois, United States
OSF Saint Francis Medical Center
Peoria, Illinois, United States
Memorial Medical Center
Springfield, Illinois, United States
Southwest Illinois Health Services LLP
Swansea, Illinois, United States
Saint Vincent Anderson Regional Hospital/Cancer Center
Anderson, Indiana, United States
Parkview Hospital Randallia
Fort Wayne, Indiana, United States
IU Health Methodist Hospital
Indianapolis, Indiana, United States
Iowa Methodist Medical Center
Des Moines, Iowa, United States
University of Iowa/Holden Comprehensive Cancer Center
Iowa City, Iowa, United States
Ascension Via Christi Hospitals Wichita
Wichita, Kansas, United States
University of Kentucky/Markey Cancer Center
Lexington, Kentucky, United States
The James Graham Brown Cancer Center at University of Louisville
Louisville, Kentucky, United States
University of Maryland/Greenebaum Cancer Center
Baltimore, Maryland, United States
UM Upper Chesapeake Medical Center
Bel Air, Maryland, United States
Walter Reed National Military Medical Center
Bethesda, Maryland, United States
Boston Medical Center
Boston, Massachusetts, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States
GenesisCare USA - Clarkston
Clarkston, Michigan, United States
Henry Ford Hospital
Detroit, Michigan, United States
GenesisCare USA - Farmington Hills
Farmington Hills, Michigan, United States
McLaren Cancer Institute-Flint
Flint, Michigan, United States
McLaren Cancer Institute-Macomb
Mount Clemens, Michigan, United States
McLaren Cancer Institute-Northern Michigan
Petoskey, Michigan, United States
Saint Joseph Mercy Oakland
Pontiac, Michigan, United States
GenesisCare USA - Troy
Troy, Michigan, United States
Henry Ford West Bloomfield Hospital
West Bloomfield, Michigan, United States
Mercy Hospital
Coon Rapids, Minnesota, United States
Mayo Clinic in Rochester
Rochester, Minnesota, United States
Washington University School of Medicine
St Louis, Missouri, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
Virtua Memorial
Mount Holly, New Jersey, United States
Cooper CyberKnife Center
Mount Laurel, New Jersey, United States
Community Medical Center
Toms River, New Jersey, United States
Virtua Voorhees
Voorhees Township, New Jersey, United States
University of New Mexico Cancer Center
Albuquerque, New Mexico, United States
Northwell Health/Center for Advanced Medicine
Lake Success, New York, United States
University of Rochester
Rochester, New York, United States
Montefiore Medical Center - Moses Campus
The Bronx, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
University of Cincinnati Cancer Center-UC Medical Center
Cincinnati, Ohio, United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
University of Cincinnati Cancer Center-West Chester
West Chester, Ohio, United States
Legacy Good Samaritan Hospital and Medical Center
Portland, Oregon, United States
Delaware County Memorial Hospital
Drexel Hill, Pennsylvania, United States
Reading Hospital
West Reading, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Self Regional Healthcare
Greenwood, South Carolina, United States
Ogden Regional Medical Center
Ogden, Utah, United States
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, United States
Gundersen Lutheran Medical Center
La Crosse, Wisconsin, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Zablocki Veterans Administration Medical Center
Milwaukee, Wisconsin, United States
Cross Cancer Institute
Edmonton, Alberta, Canada
CHUM - Hopital Notre-Dame
Montreal, Quebec, Canada
CHUM - Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, Canada
Jewish General Hospital
Montreal, Quebec, Canada
Kantonsspital Aarau
Aarau, , Switzerland
Countries
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References
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Chmura S, Winter KA, Robinson C, Pisansky TM, Borges V, Al-Hallaq H, Matuszak M, Park SS, Yi S, Hasan Y, Bazan J, Wong P, Yoon HA, Horton J, Gan G, Milano MT, Sigurdson ER, Moughan J, Salama JK, White J. Evaluation of Safety of Stereotactic Body Radiotherapy for the Treatment of Patients With Multiple Metastases: Findings From the NRG-BR001 Phase 1 Trial. JAMA Oncol. 2021 Jun 1;7(6):845-852. doi: 10.1001/jamaoncol.2021.0687.
Other Identifiers
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NCI-2014-00702
Identifier Type: REGISTRY
Identifier Source: secondary_id
NRG-BR001
Identifier Type: OTHER
Identifier Source: secondary_id
NRG-BR001
Identifier Type: OTHER
Identifier Source: secondary_id
NRG-BR001
Identifier Type: -
Identifier Source: org_study_id
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