Testing Whether Treating Breast Cancer Metastases With Surgery or High-Dose Radiation Improves Survival
NCT ID: NCT02364557
Last Updated: 2025-10-15
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2/PHASE3
129 participants
INTERVENTIONAL
2014-12-24
2025-09-04
Brief Summary
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Detailed Description
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I. Phase II: To determine whether ablation \[through stereotactic body radiation therapy (SBRT) (stereotactic radiosurgery) and/or surgical resection of all known metastases\] in oligometastatic breast cancer patients provides a sufficient signal for improved progression-free survival (PFS) to warrant full accrual to the Phase III portion of the trial.
II. Phase III: To determine whether ablation (through SBRT and/or surgical resection of all known metastases) in oligometastatic breast cancer patients significantly improves overall survival (OS).
SECONDARY OBJECTIVES:
I. To evaluate treated metastasis control according to tumor receptor status \[estrogen receptor (ER), progesterone receptor (PR), human epidermal growth factor receptor 2 (HER2)\], use of chemotherapy, surgery versus (vs.) ablative therapy, and number of metastases.
II. To evaluate whether the addition of ablative metastasis directed therapy significantly reduces the number of distant recurrences (new metastases) in patients who progress according to tumor receptor status (ER, PR, HER-2); use of chemotherapy, and number of metastases.
III. To evaluate adverse events in patients who receive ablative metastasis-directed therapy to all known metastases in addition to standard medical therapy compared with those treated with standard medical therapy alone.
EXPLORATORY OBJECTIVE:
I. To explore the most appropriate and clinically relevant technological parameters to ensure quality and effectiveness throughout the radiation therapy processes, including imaging, simulation, target and critical structure definition, treatment planning, image guidance, and delivery.
TRANSLATIONAL RESEARCH OBJECTIVES:
I. To determine whether \< 5 circulating tumor cells (CTCs) (per 7.5 ml of blood) is an independent prognostic (outcome) marker for improved PFS and OS in oligometastatic breast cancer.
II. To determine whether \< 5 CTCs (per 7.5 ml of blood) is an independent predictive (response to therapy) marker for improved PFS and OS in oligometastatic breast cancer.
III. To determine whether eliminating CTCs (0/7.5 ml of blood in patients with at least 2 CTCs at registration) is both a prognostic and predictive marker for improved PFS and OS.
IV. To evaluate the prognostic and predictive properties of CTC count as a continuous measure of PFS and OS.
V. To store material for retrospective analysis of circulating tumor deoxyribonucleic acid (ctDNA).
VI. To store material for retrospective analysis of circulating micro-ribonucleic acid (RNA).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Standard of Care (SOC)
Standard of care systemic therapy at the discretion of the treating physician.
No interventions assigned to this group
Standard of Care + Ablation
Standard of care systemic therapy plus ablation of all metastases by stereotactic body radiotherapy or surgery at the discretion of the treating physician.
Stereotactic Body Radiotherapy
Patients receive 1, 3, or 5 fractions of radiation, beginning within 6 weeks of study entry.
* For metastases in the peripheral lung, patients receive a single fraction of 30 Gy or 3 fractions for a total of 45 Gy.
* For a single liver metastases, patients receive a single fraction of 30 Gy.
* For metastases in the abdominal-pelvic or liver (\>1), patients receive 3 fractions for a total of 45 Gy.
* For metastases in the central lung or mediastinal/ cervical lymph nodes, patients receive 5 fractions for a total of 50 Gy.
* For spinal metastases, patients receive 1 fraction of 20 Gy.
* For non-spinal osseous metastases, patients receive 3 fractions for a total of 30 Gy.
* For thoracic/cervical spine metastases, patients receive 5 fractions for a total of 35 Gy.
Surgery
All surgical resections will be approached with intent of an R0 resection (rendering the patient with no evidence of measureable disease and pathologic negative margin) and must occur within 6 weeks of study entry. Approach to surgery will be based upon the treating surgeon. An open, laparoscopic, or thorascopic approach is acceptable.
Interventions
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Stereotactic Body Radiotherapy
Patients receive 1, 3, or 5 fractions of radiation, beginning within 6 weeks of study entry.
* For metastases in the peripheral lung, patients receive a single fraction of 30 Gy or 3 fractions for a total of 45 Gy.
* For a single liver metastases, patients receive a single fraction of 30 Gy.
* For metastases in the abdominal-pelvic or liver (\>1), patients receive 3 fractions for a total of 45 Gy.
* For metastases in the central lung or mediastinal/ cervical lymph nodes, patients receive 5 fractions for a total of 50 Gy.
* For spinal metastases, patients receive 1 fraction of 20 Gy.
* For non-spinal osseous metastases, patients receive 3 fractions for a total of 30 Gy.
* For thoracic/cervical spine metastases, patients receive 5 fractions for a total of 35 Gy.
Surgery
All surgical resections will be approached with intent of an R0 resection (rendering the patient with no evidence of measureable disease and pathologic negative margin) and must occur within 6 weeks of study entry. Approach to surgery will be based upon the treating surgeon. An open, laparoscopic, or thorascopic approach is acceptable.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Pathologically confirmed metastatic breast cancer
* Known estrogen, progesterone, and HER2 status of either primary tumor or metastasis;
* Note: estrogen, progesterone and HER2 status of metastasis preferred for stratification
* Number of allowable metastases:
* =\< 4 metastases seen on standard imaging within 60 days prior to registration when all metastatic disease is located within the following sites:
* Peripheral lung
* Osseous (bone)
* Spine
* Central lung
* Abdominal-pelvic metastases (lymph node/adrenal gland)
* Liver
* Mediastinal/cervical lymph node
* All known disease amenable to metastasis-directed therapy with either SBRT or resection
* Note: Symptomatic bone metastasis are allowed if ablative therapy can be delivered
* Note: Sites for possible surgical excision include lung, liver, adrenal gland, bone, small intestine, large intestine, ovary, and amenable nodal disease sites
* Note: Surgical stabilization is allowed for a metastasis if it is followed by conventionally fractionated external beam radiotherapy
* Maximum diameter of individual metastasis in any dimension =\< 5 cm
* There are no restrictions on distance between the metastases
* Patients must be registered within 365 days of the initial metastatic breast cancer diagnosis; first-line standard systemic therapy (chemotherapy, anti-endocrine therapy, anti-HER2, or other standard targeted therapy) for metastatic breast cancer must be given or planned to be given; if given before study entry, it cannot have exceeded a duration of 12 months at the time of registration (Note: sequencing of ablative therapy \[surgery or SBRT\] relative to systemic therapy, for patients randomized to Arm 2, is at the discretion of the treating physician)
* The primary tumor site must be controlled prior to registration
* For those who present with synchronous primary and oligometastatic disease, primary must be controlled prior to registration
* The definition of control is definitive surgery by excision or mastectomy (+/- radiotherapy) per institution preference For those who present with local recurrence and oligometastatic disease, local recurrence must be controlled prior to registration
* The definition of control is definitive surgery by excision or mastectomy (+/- radiotherapy) per institution preference
* Appropriate stage for study entry based on the following diagnostic workup:
* History/physical examination within 60 days prior to registration
* Clinical grade computed tomography (CT) scans of the chest, abdomen, and pelvis with radionuclide bone scan OR whole body positron emission tomography (PET)/CT within 60 days prior to study registration
* Zubrod performance status =\< 2 within 60 days prior to registration
* Blood cell count (CBC)/differential obtained within 60 days prior to registration on study
* Absolute neutrophil count (ANC) \>= 500 cells/mm\^3
* Platelets \>= 50,000 cells/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)
* For females of child-bearing potential, negative serum or urine pregnancy test within 14 days prior to study registration
* The patient or a legally authorized representative must provide study-specific informed consent prior to study entry
Exclusion Criteria
* Pathologic evidence of active primary disease or local/regional breast tumor recurrence at the time of registration;
* Co-existing or prior invasive malignancy (except non-melanomatous skin cancer), unless disease free for a minimum of 3 years; previous RT dose, date, fraction size, must be reported
* Metastases with indistinct borders making targeting not feasible
* Note: A potential issue with bone metastases is that they often are not discrete; since many patients on this protocol will have bone metastases, this will be an important issue; theoretically, Houndsfield units might provide an appropriate measure; however, a sclerotic lesion against dense cortical bone will not have a sharp demarcation based on Houndsfield units (HU); therefore, we acknowledge that such determinations will pose a challenge and thus the physician's judgment will be required
* Prior palliative radiation treatment for metastatic disease to be treated on the protocol (including radiopharmaceuticals)
* 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)
* Brainstem previously irradiated to \> 50 Gy (delivered in =\< 3 Gy/fraction)
* Whole lung previously irradiated with prior percent volume receiving greater than or equal to 20 Gy (V20Gy)\> 30% (delivered in =\< 3 Gy/fraction)
* Primary tumor irradiated with SBRT
* Metastasis irradiated with SBRT
* Brain metastases
* Exudative, bloody, or cytological proven malignant effusions
* Severe, active co-morbidity defined as follows:
* Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months
* Transmural myocardial infarction within the last 6 months
* 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 at the time of registration
* Pregnancy; lactating females must cease expression of milk prior to signing consent to be eligible
* 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 cluster of differentiation 4 (CD4) count \>= 200 cells/microliter within 30 days prior to registration; note also that HIV testing is not required for eligibility for this protocol
18 Years
FEMALE
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 J Chmura
Role: PRINCIPAL_INVESTIGATOR
NRG Oncology
Locations
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University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, United States
CTCA at Western Regional Medical Center
Goodyear, Arizona, United States
Arizona Center for Cancer Care-Peoria
Peoria, Arizona, United States
Banner University Medical Center - Tucson
Tucson, Arizona, United States
Alta Bates Summit Medical Center-Herrick Campus
Berkeley, California, United States
UC San Diego Moores Cancer Center
La Jolla, California, United States
Los Angeles General Medical Center
Los Angeles, California, United States
USC / Norris Comprehensive Cancer Center
Los Angeles, California, United States
Cedars Sinai Medical Center
Los Angeles, California, United States
UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange, California, United States
The Permanente Medical Group-Roseville Radiation Oncology
Roseville, California, United States
Sutter Medical Center Sacramento
Sacramento, California, United States
University of California Davis Comprehensive Cancer Center
Sacramento, California, United States
Naval Medical Center -San Diego
San Diego, California, United States
Kaiser Permanente Cancer Treatment Center
South San Francisco, California, United States
Saint Joseph's Medical Center
Stockton, California, United States
Gene Upshaw Memorial Tahoe Forest Cancer Center
Truckee, California, United States
UCHealth University of Colorado Hospital
Aurora, Colorado, United States
Penrose-Saint Francis Healthcare
Colorado Springs, Colorado, United States
UCHealth Memorial Hospital Central
Colorado Springs, Colorado, United States
Poudre Valley Hospital
Fort Collins, Colorado, United States
McKee Medical Center
Loveland, Colorado, United States
Helen F Graham Cancer Center
Newark, Delaware, United States
University of Florida Health Science Center - Gainesville
Gainesville, Florida, United States
Memorial Regional Hospital/Joe DiMaggio Children's Hospital
Hollywood, Florida, United States
Mayo Clinic in Florida
Jacksonville, Florida, United States
Miami Cancer Institute
Miami, Florida, United States
Orlando Health Cancer Institute
Orlando, Florida, United States
Memorial Hospital West
Pembroke Pines, Florida, United States
Emory University Hospital Midtown
Atlanta, Georgia, United States
Piedmont Hospital
Atlanta, Georgia, United States
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, United States
Emory Saint Joseph's Hospital
Atlanta, Georgia, United States
John B Amos Cancer Center
Columbus, Georgia, United States
CTCA at Southeastern Regional Medical Center
Newnan, Georgia, United States
Lewis Hall Singletary Oncology Center
Thomasville, Georgia, United States
Queen's Medical Center
Honolulu, Hawaii, United States
The Cancer Center of Hawaii-Liliha
Honolulu, Hawaii, United States
Northwestern University
Chicago, Illinois, United States
Rush University Medical Center
Chicago, Illinois, United States
University of Illinois
Chicago, Illinois, United States
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, United States
Decatur Memorial Hospital
Decatur, Illinois, United States
Northwestern Medicine Cancer Center Delnor
Geneva, Illinois, United States
Loyola University Medical Center
Maywood, Illinois, United States
Methodist Medical Center of Illinois
Peoria, Illinois, United States
Memorial Medical Center
Springfield, Illinois, United States
Southwest Illinois Health Services LLP
Swansea, Illinois, United States
Carle Cancer Center
Urbana, Illinois, United States
Northwestern Medicine Cancer Center Warrenville
Warrenville, Illinois, United States
Midwestern Regional Medical Center
Zion, Illinois, United States
Ascension Saint Vincent Anderson
Anderson, Indiana, United States
Parkview Hospital Randallia
Fort Wayne, Indiana, United States
Parkview Regional Medical Center
Fort Wayne, Indiana, United States
IU Health Ball Memorial Hospital
Muncie, Indiana, United States
Memorial Hospital of South Bend
South Bend, Indiana, United States
Ascension Via Christi Hospitals Wichita
Wichita, Kansas, United States
Owensboro Health Mitchell Memorial Cancer Center
Owensboro, Kentucky, United States
MaineHealth Coastal Cancer Treatment Center
Bath, Maine, United States
MaineHealth/SMHC Cancer Care and Blood Disorders-Biddeford
Biddeford, Maine, United States
Maine Medical Center-Bramhall Campus
Portland, Maine, United States
MaineHealth Cancer Care Center of York County
Sanford, Maine, United States
MaineHealth/SMHC Cancer Care and Blood Disorders-Sanford
Sanford, Maine, United States
Maine Medical Center- Scarborough Campus
Scarborough, Maine, United States
University of Maryland/Greenebaum Cancer Center
Baltimore, Maryland, United States
Greater Baltimore Medical Center
Baltimore, Maryland, United States
UM Upper Chesapeake Medical Center
Bel Air, Maryland, United States
Central Maryland Radiation Oncology in Howard County
Columbia, Maryland, United States
Lahey Hospital and Medical Center
Burlington, Massachusetts, United States
Lowell General Hospital
Lowell, Massachusetts, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States
Henry Ford Cancer Institute-Downriver
Brownstown, Michigan, United States
Michigan Healthcare Professionals Clarkston
Clarkston, Michigan, United States
Henry Ford Macomb Hospital-Clinton Township
Clinton Township, Michigan, United States
Henry Ford Hospital
Detroit, Michigan, United States
Michigan Healthcare Professionals Farmington
Farmington Hills, Michigan, United States
West Michigan Cancer Center
Kalamazoo, Michigan, United States
Saint Joseph Mercy Oakland
Pontiac, Michigan, United States
William Beaumont Hospital-Royal Oak
Royal Oak, 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
Saint Luke's Hospital of Duluth
Duluth, Minnesota, United States
Mayo Clinic in Rochester
Rochester, Minnesota, United States
Regions Hospital
Saint Paul, Minnesota, United States
Saint Francis Medical Center
Cape Girardeau, Missouri, United States
Washington University School of Medicine
St Louis, Missouri, United States
Mercy Hospital South
St Louis, Missouri, United States
Missouri Baptist Medical Center
St Louis, Missouri, United States
Benefis Healthcare- Sletten Cancer Institute
Great Falls, Montana, United States
Kalispell Regional Medical Center
Kalispell, Montana, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
Renown Regional Medical Center
Reno, Nevada, United States
Wentworth-Douglass Hospital
Dover, New Hampshire, United States
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
Lebanon, New Hampshire, United States
Virtua Memorial
Mount Holly, New Jersey, United States
Community Medical Center
Toms River, New Jersey, United States
Virtua Voorhees
Voorhees Township, New Jersey, United States
Lovelace Medical Center-Saint Joseph Square
Albuquerque, New Mexico, United States
University of New Mexico Cancer Center
Albuquerque, New Mexico, United States
Lovelace Radiation Oncology
Albuquerque, New Mexico, United States
New Mexico Oncology Hematology Consultants
Albuquerque, New Mexico, United States
Christus Saint Vincent Regional Cancer Center
Santa Fe, New Mexico, United States
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
New York, New York, United States
University of Rochester
Rochester, New York, United States
Montefiore Medical Center - Moses Campus
The Bronx, New York, United States
Dickstein Cancer Treatment Center
White Plains, New York, United States
Rex Hematology Oncology Associates-Cary
Cary, North Carolina, United States
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
Rex Hematology Oncology Associates-Garner
Garner, North Carolina, United States
Rex Hematology Oncology Associates-Blue Ridge
Raleigh, North Carolina, United States
UNC Rex Healthcare
Raleigh, North Carolina, United States
UNC Rex Cancer Center of Wakefield
Raleigh, North Carolina, United States
Novant Cancer Institute Radiation Oncology - Supply
Supply, North Carolina, United States
Novant Health Cancer Institute Radiation Oncology - Wilmington
Wilmington, North Carolina, United States
Novant Health New Hanover Regional Medical Center
Wilmington, North Carolina, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
Sanford Bismarck Medical Center
Bismarck, North Dakota, United States
Cleveland Clinic Akron General
Akron, Ohio, United States
Case Western Reserve University
Cleveland, Ohio, United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
ProMedica Flower Hospital
Sylvania, Ohio, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
Legacy Mount Hood Medical Center
Gresham, Oregon, United States
Legacy Good Samaritan Hospital and Medical Center
Portland, Oregon, United States
Providence Portland Medical Center
Portland, Oregon, United States
Providence Saint Vincent Medical Center
Portland, Oregon, United States
UPMC Pinnacle Cancer Center/Community Osteopathic Campus
Harrisburg, Pennsylvania, United States
University of Pennsylvania/Abramson Cancer Center
Philadelphia, Pennsylvania, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States
UPMC-Shadyside Hospital
Pittsburgh, Pennsylvania, United States
Guthrie Medical Group PC-Robert Packer Hospital
Sayre, Pennsylvania, United States
Reading Hospital
West Reading, Pennsylvania, United States
Self Regional Healthcare
Greenwood, South Carolina, United States
Gibbs Cancer Center-Pelham
Greer, South Carolina, United States
Spartanburg Medical Center
Spartanburg, South Carolina, United States
Texas Oncology-Austin Midtown
Austin, Texas, United States
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas, United States
M D Anderson Cancer Center
Houston, Texas, United States
Ogden Regional Medical Center
Ogden, Utah, United States
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, United States
Inova Fairfax Hospital
Falls Church, Virginia, United States
Bon Secours Saint Mary's Hospital
Richmond, Virginia, United States
Legacy Salmon Creek Hospital
Vancouver, Washington, United States
Edwards Comprehensive Cancer Center
Huntington, West Virginia, United States
West Virginia University Healthcare
Morgantown, West Virginia, United States
Saint Vincent Hospital Cancer Center Green Bay
Green Bay, Wisconsin, United States
Saint Vincent Hospital Cancer Center at Saint Mary's
Green Bay, Wisconsin, United States
Gundersen Lutheran Medical Center
La Crosse, Wisconsin, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Marshfield Medical Center-River Region at Stevens Point
Stevens Point, Wisconsin, United States
Froedtert West Bend Hospital/Kraemer Cancer Center
West Bend, Wisconsin, United States
Diagnostic and Treatment Center
Weston, Wisconsin, United States
Tom Baker Cancer Centre
Calgary, Alberta, Canada
Cross Cancer Institute
Edmonton, Alberta, Canada
London Regional Cancer Program
London, Ontario, Canada
Ottawa Hospital and Cancer Center-General Campus
Ottawa, Ontario, Canada
CHUM - Hopital Notre-Dame
Montreal, Quebec, Canada
McGill University Department of Oncology
Montreal, Quebec, Canada
CHUM - Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, Canada
The Research Institute of the McGill University Health Centre (MUHC)
Montreal, Quebec, Canada
Jewish General Hospital
Montreal, Quebec, Canada
King Faisal Specialist Hospital and Research Centre
Riyadh, , Saudi Arabia
Yonsei University Health System-Severance Hospital
Seoul, , South Korea
Countries
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References
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Petrelli F, Ghidini A, Ghidini M, Bukovec R, Trevisan F, Turati L, Indini A, Seghezzi S, Lonati V, Moleri G, Tomasello G, Zaniboni A. Better survival of patients with oligo- compared with polymetastatic cancers: a systematic review and meta-analysis of 173 studies. F1000Res. 2021 May 27;10:423. doi: 10.12688/f1000research.52546.4. eCollection 2021.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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NCI-2014-01810
Identifier Type: REGISTRY
Identifier Source: secondary_id
NRG-BR002
Identifier Type: -
Identifier Source: secondary_id
NRG-BR002
Identifier Type: OTHER
Identifier Source: secondary_id
NRG-BR002
Identifier Type: OTHER
Identifier Source: secondary_id
NRG-BR002
Identifier Type: -
Identifier Source: org_study_id
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