Stereotactic Body Radiation Therapy in Treating Patients With Metastatic Breast Cancer, Non-small Cell Lung Cancer, or Prostate Cancer
A Phase 1 Study of Stereotactic Body Radiotherapy (SBRT) for the Treatment of Multiple Metastases
4 other identifiers
interventional
42
3 countries
78
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Aug 2014
Longer than P75 for phase_1
78 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 30, 2014
CompletedFirst Posted
Study publicly available on registry
August 1, 2014
CompletedStudy Start
First participant enrolled
August 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
May 20, 2022
CompletedMay 25, 2022
May 1, 2022
3.8 years
July 30, 2014
May 23, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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.
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 Outcomes (2)
Rate of long-term adverse events, scored according to the NCI CTCAE v. 4.0
Up to 2 years from end of treatment; analysis occurs after all patients have been potentially followed for 2 years from registration
Rates of >= grade 3 adverse events, scored according to NCI CTCAE v. 4.0
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
Study Arms (1)
Stereotactic Body Radiation Therapy (SBRT)
EXPERIMENTALPatients 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.
Interventions
Undergo SBRT
Eligibility Criteria
You may qualify if:
- 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:
- radiographically distinct metastases of any distribution in the allowed anatomical sites OR
- radiographically distinct metastases that must be anatomically close (i.e., with less than or equal to 5 cm of normal tissue between them) OR
- 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
- +6 more criteria
You may not qualify if:
- 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
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- NRG Oncologylead
- National Cancer Institute (NCI)collaborator
Study Sites (78)
University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, 35233, United States
Arizona Center for Cancer Care-Peoria
Peoria, Arizona, 85381, United States
Banner University Medical Center - Tucson
Tucson, Arizona, 85719, United States
City of Hope Comprehensive Cancer Center
Duarte, California, 91010, United States
UC San Diego Moores Cancer Center
La Jolla, California, 92093, United States
USC / Norris Comprehensive Cancer Center
Los Angeles, California, 90033, United States
Sutter Medical Center Sacramento
Sacramento, California, 95816, United States
University of California Davis Comprehensive Cancer Center
Sacramento, California, 95817, United States
University of Colorado Hospital
Aurora, Colorado, 80045, United States
Poudre Valley Hospital
Fort Collins, Colorado, 80524, United States
University of Florida Health Science Center - Gainesville
Gainesville, Florida, 32610, United States
University of Florida Health Science Center - Jacksonville
Jacksonville, Florida, 32209, United States
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, 33136, United States
Grady Health System
Atlanta, Georgia, 30303, United States
Emory University Hospital Midtown
Atlanta, Georgia, 30308, United States
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, 30322, United States
Northwest Community Hospital
Arlington Heights, Illinois, 60005, United States
Northwestern University
Chicago, Illinois, 60611, United States
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, 60637, United States
Decatur Memorial Hospital
Decatur, Illinois, 62526, United States
Loyola University Medical Center
Maywood, Illinois, 60153, United States
OSF Saint Francis Medical Center
Peoria, Illinois, 61637, United States
Memorial Medical Center
Springfield, Illinois, 62781, United States
Southwest Illinois Health Services LLP
Swansea, Illinois, 62226, United States
Saint Vincent Anderson Regional Hospital/Cancer Center
Anderson, Indiana, 46016, United States
Parkview Hospital Randallia
Fort Wayne, Indiana, 46805, United States
IU Health Methodist Hospital
Indianapolis, Indiana, 46202, United States
Iowa Methodist Medical Center
Des Moines, Iowa, 50309, United States
University of Iowa/Holden Comprehensive Cancer Center
Iowa City, Iowa, 52242, United States
Ascension Via Christi Hospitals Wichita
Wichita, Kansas, 67214, United States
University of Kentucky/Markey Cancer Center
Lexington, Kentucky, 40536, United States
The James Graham Brown Cancer Center at University of Louisville
Louisville, Kentucky, 40202, United States
University of Maryland/Greenebaum Cancer Center
Baltimore, Maryland, 21201, United States
UM Upper Chesapeake Medical Center
Bel Air, Maryland, 21014, United States
Walter Reed National Military Medical Center
Bethesda, Maryland, 20889-5600, United States
Boston Medical Center
Boston, Massachusetts, 02118, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109, United States
GenesisCare USA - Clarkston
Clarkston, Michigan, 48346, United States
Henry Ford Hospital
Detroit, Michigan, 48202, United States
GenesisCare USA - Farmington Hills
Farmington Hills, Michigan, 48334, 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
Saint Joseph Mercy Oakland
Pontiac, Michigan, 48341, United States
GenesisCare USA - Troy
Troy, Michigan, 48098, United States
Henry Ford West Bloomfield Hospital
West Bloomfield, Michigan, 48322, United States
Mercy Hospital
Coon Rapids, Minnesota, 55433, United States
Mayo Clinic in Rochester
Rochester, Minnesota, 55905, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198, United States
Virtua Memorial
Mount Holly, New Jersey, 08060, United States
Cooper CyberKnife Center
Mount Laurel, New Jersey, 08054, United States
Community Medical Center
Toms River, New Jersey, 08755, United States
Virtua Voorhees
Voorhees Township, New Jersey, 08043, United States
University of New Mexico Cancer Center
Albuquerque, New Mexico, 87102, United States
Northwell Health/Center for Advanced Medicine
Lake Success, New York, 11042, United States
University of Rochester
Rochester, New York, 14642, United States
Montefiore Medical Center - Moses Campus
The Bronx, New York, 10467, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157, United States
University of Cincinnati Cancer Center-UC Medical Center
Cincinnati, Ohio, 45219, United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210, United States
University of Cincinnati Cancer Center-West Chester
West Chester, Ohio, 45069, United States
Legacy Good Samaritan Hospital and Medical Center
Portland, Oregon, 97210, United States
Delaware County Memorial Hospital
Drexel Hill, Pennsylvania, 19026, United States
Reading Hospital
West Reading, Pennsylvania, 19611, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Self Regional Healthcare
Greenwood, South Carolina, 29646, United States
Ogden Regional Medical Center
Ogden, Utah, 84405, United States
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, 84112, United States
Gundersen Lutheran Medical Center
La Crosse, Wisconsin, 54601, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Zablocki Veterans Administration Medical Center
Milwaukee, Wisconsin, 53295, United States
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2, Canada
CHUM - Hopital Notre-Dame
Montreal, Quebec, H2L 4M1, Canada
CHUM - Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, H2X 3E4, Canada
Jewish General Hospital
Montreal, Quebec, H3T 1E2, Canada
Kantonsspital Aarau
Aarau, 5001, Switzerland
Related Publications (1)
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.
PMID: 33885704DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Steven Chmura
NRG Oncology
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 30, 2014
First Posted
August 1, 2014
Study Start
August 1, 2014
Primary Completion
June 1, 2018
Study Completion
May 20, 2022
Last Updated
May 25, 2022
Record last verified: 2022-05