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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2014-00702 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| NRG-BR001 | Other Identifier | NRG Oncology | |
| NRG-BR001 | Other Identifier | CTEP | |
| U10CA180868 | U.S. NIH Grant/Contract | View source | |
| U10CA021661 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stereotactic Body Radiation Therapy (SBRT) | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stereotactic Body Radiation Therapy (SBRT) | Radiation | Undergo SBRT |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 2 years from end of treatment; analysis occurs after all patients have been potentially followed for 2 years from registration |
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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
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:
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:
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:
Severe, active co-morbidity, defined as follows:
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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| Name | Affiliation | Role |
|---|---|---|
| Steven Chmura | NRG Oncology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham Cancer Center | Birmingham | Alabama | 35233 | United States | ||
| Arizona Center for Cancer Care-Peoria |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33885704 | Derived | 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. |
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NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page
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| 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. |
| 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 |
| 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 |
| UCHealth University of Colorado Hospital | Aurora | Colorado | 80045 | United States |
| Poudre Valley Hospital | Fort Collins | Colorado | 80524 | United States |
| UF Health Cancer Institute - 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 |
| Springfield Memorial Hospital | Springfield | Illinois | 62781 | United States |
| Southwest Illinois Health Services LLP | Swansea | Illinois | 62226 | United States |
| Ascension Saint Vincent Anderson | 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 Rogel Cancer Center | Ann Arbor | Michigan | 48109 | United States |
| Michigan Healthcare Professionals Clarkston | Clarkston | Michigan | 48346 | United States |
| Henry Ford Hospital | Detroit | Michigan | 48202 | United States |
| Michigan Healthcare Professionals Farmington | 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 |
| Trinity Health Saint Joseph Mercy Oakland Hospital | Pontiac | Michigan | 48341 | United States |
| Michigan Healthcare Professionals 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 | 87106 | 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 |
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | 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 - 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 |
| ID | Term |
|---|---|
| D018567 | Breast Neoplasms, Male |
| D001943 | Breast Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D016634 | Radiosurgery |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D013238 | Stereotaxic Techniques |
| D019635 | Neurosurgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
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