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Stereotactic Body Radiation Therapy in Treating Patients With Metastatic Breast Cancer, Non-small Cell Lung Cancer, or Prostate Cancer

Primary Purpose

Male Breast Carcinoma, Prostate Adenocarcinoma, Recurrent Breast Carcinoma

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Stereotactic Body Radiation Therapy (SBRT)
Sponsored by
NRG Oncology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Male Breast Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Alabama at Birmingham Cancer Center
  • Arizona Center for Cancer Care-Peoria
  • Banner University Medical Center - Tucson
  • City of Hope Comprehensive Cancer Center
  • UC San Diego Moores Cancer Center
  • USC / Norris Comprehensive Cancer Center
  • Sutter Medical Center Sacramento
  • University of California Davis Comprehensive Cancer Center
  • University of Colorado Hospital
  • Poudre Valley Hospital
  • University of Florida Health Science Center - Gainesville
  • University of Florida Health Science Center - Jacksonville
  • University of Miami Miller School of Medicine-Sylvester Cancer Center
  • Grady Health System
  • Emory University Hospital Midtown
  • Emory University Hospital/Winship Cancer Institute
  • Northwest Community Hospital
  • Northwestern University
  • University of Chicago Comprehensive Cancer Center
  • Decatur Memorial Hospital
  • Loyola University Medical Center
  • OSF Saint Francis Medical Center
  • Memorial Medical Center
  • Southwest Illinois Health Services LLP
  • Saint Vincent Anderson Regional Hospital/Cancer Center
  • Parkview Hospital Randallia
  • IU Health Methodist Hospital
  • Iowa Methodist Medical Center
  • University of Iowa/Holden Comprehensive Cancer Center
  • Ascension Via Christi Hospitals Wichita
  • University of Kentucky/Markey Cancer Center
  • The James Graham Brown Cancer Center at University of Louisville
  • University of Maryland/Greenebaum Cancer Center
  • UM Upper Chesapeake Medical Center
  • Walter Reed National Military Medical Center
  • Boston Medical Center
  • University of Michigan Comprehensive Cancer Center
  • GenesisCare USA - Clarkston
  • Henry Ford Hospital
  • GenesisCare USA - Farmington Hills
  • McLaren Cancer Institute-Flint
  • McLaren Cancer Institute-Macomb
  • McLaren Cancer Institute-Northern Michigan
  • Saint Joseph Mercy Oakland
  • GenesisCare USA - Troy
  • Henry Ford West Bloomfield Hospital
  • Mercy Hospital
  • Mayo Clinic in Rochester
  • Washington University School of Medicine
  • University of Nebraska Medical Center
  • Virtua Memorial
  • Cooper CyberKnife Center
  • Community Medical Center
  • Virtua Voorhees
  • University of New Mexico Cancer Center
  • Montefiore Medical Center - Moses Campus
  • Northwell Health/Center for Advanced Medicine
  • University of Rochester
  • Duke University Medical Center
  • Wake Forest University Health Sciences
  • University of Cincinnati Cancer Center-UC Medical Center
  • Ohio State University Comprehensive Cancer Center
  • University of Cincinnati Cancer Center-West Chester
  • Legacy Good Samaritan Hospital and Medical Center
  • Delaware County Memorial Hospital
  • Reading Hospital
  • Medical University of South Carolina
  • Self Regional Healthcare
  • Ogden Regional Medical Center
  • Huntsman Cancer Institute/University of Utah
  • Gundersen Lutheran Medical Center
  • Medical College of Wisconsin
  • Zablocki Veterans Administration Medical Center
  • Cross Cancer Institute
  • CHUM - Hopital Notre-Dame
  • CHUM - Centre Hospitalier de l'Universite de Montreal
  • Jewish General Hospital
  • Kantonsspital Aarau

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Stereotactic Body Radiation Therapy (SBRT)

Arm Description

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.

Outcomes

Primary Outcome Measures

Dose-limiting toxicity (DLT) scored according to the National Cancer Institute (NCI) CTCAE version 4.0 for each of 7 metastatic locations when multiple metastases are treated with SBRT
Adverse events outlined by metastatic location (full detail in protocol) reported as being probably or definitely related to protocol treatment.

Secondary Outcome Measures

Rate of long-term adverse events, scored according to the NCI CTCAE v. 4.0
Adverse events reported as being possibly, probably, or definitely related to protocol treatment.
Rates of >= grade 3 adverse events, scored according to NCI CTCAE v. 4.0
Adverse events (other than DLTs) reported as being possibly, probably, or definitely related to protocol treatment.

Full Information

First Posted
July 30, 2014
Last Updated
May 23, 2022
Sponsor
NRG Oncology
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT02206334
Brief Title
Stereotactic Body Radiation Therapy in Treating Patients With Metastatic Breast Cancer, Non-small Cell Lung Cancer, or Prostate Cancer
Official Title
A Phase 1 Study of Stereotactic Body Radiotherapy (SBRT) for the Treatment of Multiple Metastases
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
August 2014 (Actual)
Primary Completion Date
June 2018 (Actual)
Study Completion Date
May 20, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NRG Oncology
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This phase I trial studies the side effects and the best dose of stereotactic body radiation therapy in treating patients with breast cancer, non-small cell lung cancer, or prostate cancer that has spread to other parts of the body. Stereotactic body radiation therapy delivers fewer, tightly-focused, high doses of radiation therapy to all known sites of cancer in the body while minimizing radiation exposure of surrounding normal tissue.
Detailed Description
PRIMARY OBJECTIVES: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Stereotactic Body Radiation Therapy (SBRT)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Radiation
Intervention Name(s)
Stereotactic Body Radiation Therapy (SBRT)
Other Intervention Name(s)
Stereotactic External Beam Irradiation, stereotactic external-beam radiation therapy, Stereotactic Radiation Therapy, stereotactic radiosurgery, Stereotactic Radiotherapy, stereotaxic radiation therapy, stereotaxic radiosurgery, SBRT
Intervention Description
Undergo SBRT
Primary Outcome Measure Information:
Title
Dose-limiting toxicity (DLT) scored according to the National Cancer Institute (NCI) CTCAE version 4.0 for each of 7 metastatic locations when multiple metastases are treated with SBRT
Description
Adverse events outlined by metastatic location (full detail in protocol) reported as being probably or definitely related to protocol treatment.
Time Frame
Within 6 months from the start of treatment; for each of the 7 metastatic locations, analysis occurs after 6 evaluable patients have been followed for a minimum of 6 months from the start of treatment
Secondary Outcome Measure Information:
Title
Rate of long-term adverse events, scored according to the NCI CTCAE v. 4.0
Description
Adverse events reported as being possibly, probably, or definitely related to protocol treatment.
Time Frame
Up to 2 years from end of treatment; analysis occurs after all patients have been potentially followed for 2 years from registration
Title
Rates of >= grade 3 adverse events, scored according to NCI CTCAE v. 4.0
Description
Adverse events (other than DLTs) reported as being possibly, probably, or definitely related to protocol treatment.
Time Frame
Within 6 months from the start of treatment; analysis occurs after all patients have been followed for a minimum of 6 months from the start of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven Chmura
Organizational Affiliation
NRG Oncology
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham Cancer Center
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
Arizona Center for Cancer Care-Peoria
City
Peoria
State/Province
Arizona
ZIP/Postal Code
85381
Country
United States
Facility Name
Banner University Medical Center - Tucson
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85719
Country
United States
Facility Name
City of Hope Comprehensive Cancer Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Facility Name
UC San Diego Moores Cancer Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
USC / Norris Comprehensive Cancer Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Sutter Medical Center Sacramento
City
Sacramento
State/Province
California
ZIP/Postal Code
95816
Country
United States
Facility Name
University of California Davis Comprehensive Cancer Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
University of Colorado Hospital
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Poudre Valley Hospital
City
Fort Collins
State/Province
Colorado
ZIP/Postal Code
80524
Country
United States
Facility Name
University of Florida Health Science Center - Gainesville
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
University of Florida Health Science Center - Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32209
Country
United States
Facility Name
University of Miami Miller School of Medicine-Sylvester Cancer Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Grady Health System
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30303
Country
United States
Facility Name
Emory University Hospital Midtown
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
Emory University Hospital/Winship Cancer Institute
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Northwest Community Hospital
City
Arlington Heights
State/Province
Illinois
ZIP/Postal Code
60005
Country
United States
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
University of Chicago Comprehensive Cancer Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Decatur Memorial Hospital
City
Decatur
State/Province
Illinois
ZIP/Postal Code
62526
Country
United States
Facility Name
Loyola University Medical Center
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Facility Name
OSF Saint Francis Medical Center
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61637
Country
United States
Facility Name
Memorial Medical Center
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62781
Country
United States
Facility Name
Southwest Illinois Health Services LLP
City
Swansea
State/Province
Illinois
ZIP/Postal Code
62226
Country
United States
Facility Name
Saint Vincent Anderson Regional Hospital/Cancer Center
City
Anderson
State/Province
Indiana
ZIP/Postal Code
46016
Country
United States
Facility Name
Parkview Hospital Randallia
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46805
Country
United States
Facility Name
IU Health Methodist Hospital
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Iowa Methodist Medical Center
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50309
Country
United States
Facility Name
University of Iowa/Holden Comprehensive Cancer Center
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Ascension Via Christi Hospitals Wichita
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Facility Name
University of Kentucky/Markey Cancer Center
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Name
The James Graham Brown Cancer Center at University of Louisville
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
University of Maryland/Greenebaum Cancer Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
UM Upper Chesapeake Medical Center
City
Bel Air
State/Province
Maryland
ZIP/Postal Code
21014
Country
United States
Facility Name
Walter Reed National Military Medical Center
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20889-5600
Country
United States
Facility Name
Boston Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
University of Michigan Comprehensive Cancer Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
GenesisCare USA - Clarkston
City
Clarkston
State/Province
Michigan
ZIP/Postal Code
48346
Country
United States
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
GenesisCare USA - Farmington Hills
City
Farmington Hills
State/Province
Michigan
ZIP/Postal Code
48334
Country
United States
Facility Name
McLaren Cancer Institute-Flint
City
Flint
State/Province
Michigan
ZIP/Postal Code
48532
Country
United States
Facility Name
McLaren Cancer Institute-Macomb
City
Mount Clemens
State/Province
Michigan
ZIP/Postal Code
48043
Country
United States
Facility Name
McLaren Cancer Institute-Northern Michigan
City
Petoskey
State/Province
Michigan
ZIP/Postal Code
49770
Country
United States
Facility Name
Saint Joseph Mercy Oakland
City
Pontiac
State/Province
Michigan
ZIP/Postal Code
48341
Country
United States
Facility Name
GenesisCare USA - Troy
City
Troy
State/Province
Michigan
ZIP/Postal Code
48098
Country
United States
Facility Name
Henry Ford West Bloomfield Hospital
City
West Bloomfield
State/Province
Michigan
ZIP/Postal Code
48322
Country
United States
Facility Name
Mercy Hospital
City
Coon Rapids
State/Province
Minnesota
ZIP/Postal Code
55433
Country
United States
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
University of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States
Facility Name
Virtua Memorial
City
Mount Holly
State/Province
New Jersey
ZIP/Postal Code
08060
Country
United States
Facility Name
Cooper CyberKnife Center
City
Mount Laurel
State/Province
New Jersey
ZIP/Postal Code
08054
Country
United States
Facility Name
Community Medical Center
City
Toms River
State/Province
New Jersey
ZIP/Postal Code
08755
Country
United States
Facility Name
Virtua Voorhees
City
Voorhees
State/Province
New Jersey
ZIP/Postal Code
08043
Country
United States
Facility Name
University of New Mexico Cancer Center
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102
Country
United States
Facility Name
Montefiore Medical Center - Moses Campus
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
Northwell Health/Center for Advanced Medicine
City
Lake Success
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Facility Name
University of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Wake Forest University Health Sciences
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
University of Cincinnati Cancer Center-UC Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Ohio State University Comprehensive Cancer Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
University of Cincinnati Cancer Center-West Chester
City
West Chester
State/Province
Ohio
ZIP/Postal Code
45069
Country
United States
Facility Name
Legacy Good Samaritan Hospital and Medical Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Delaware County Memorial Hospital
City
Drexel Hill
State/Province
Pennsylvania
ZIP/Postal Code
19026
Country
United States
Facility Name
Reading Hospital
City
West Reading
State/Province
Pennsylvania
ZIP/Postal Code
19611
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Self Regional Healthcare
City
Greenwood
State/Province
South Carolina
ZIP/Postal Code
29646
Country
United States
Facility Name
Ogden Regional Medical Center
City
Ogden
State/Province
Utah
ZIP/Postal Code
84405
Country
United States
Facility Name
Huntsman Cancer Institute/University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Facility Name
Gundersen Lutheran Medical Center
City
La Crosse
State/Province
Wisconsin
ZIP/Postal Code
54601
Country
United States
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Zablocki Veterans Administration Medical Center
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53295
Country
United States
Facility Name
Cross Cancer Institute
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada
Facility Name
CHUM - Hopital Notre-Dame
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2L 4M1
Country
Canada
Facility Name
CHUM - Centre Hospitalier de l'Universite de Montreal
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2X 3E4
Country
Canada
Facility Name
Jewish General Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada
Facility Name
Kantonsspital Aarau
City
Aarau
ZIP/Postal Code
5001
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
33885704
Citation
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.
Results Reference
derived

Learn more about this trial

Stereotactic Body Radiation Therapy in Treating Patients With Metastatic Breast Cancer, Non-small Cell Lung Cancer, or Prostate Cancer

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