Pemetrexed Disodium or Erlotinib Hydrochloride as Second-Line Therapy in Treating Patients With Advanced Non-small Cell Lung Cancer
NCT ID: NCT00738881
Last Updated: 2015-10-29
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
23 participants
INTERVENTIONAL
2008-10-31
2014-12-31
Brief Summary
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Detailed Description
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I. To evaluate whether there are differences in progression-free survival due to treatment with erlotinib (erlotinib hydrochloride) compared to pemetrexed (pemetrexed disodium) for subsets of previously treated non-small cell lung cancer (NSCLC) patients defined by epidermal growth factor receptor (EGFR)-fluorescent in situ hybridization (FISH) positive versus negativity.
SECONDARY OBJECTIVES:
I. Ascertain the presence or absence of true differences due to treatment in the objective clinical endpoints of overall survival, confirmed response rate, and adverse event profile for subsets of patients defined on the basis of the epidermal growth factor receptor (EGFR)-FISH positivity versus negativity.
II. Ascertain the presence or absence of true differences due to treatment in objective clinical endpoints (i.e., progression free survival, overall survival, confirmed response rate, and adverse event profile) for subsets of patients defined on the basis of the epidermal growth factor receptor (EGFR) expression as measured by immunohistochemistry (IHC).
III. Ascertain the presence or absence of true differences due to treatment in objective clinical endpoints (i.e., progression free survival, overall survival, confirmed response rate, and adverse event profile) for subsets of patients defined on the basis of the epidermal growth factor receptor (EGFR) gene mutation status (MUT).
IV. To evaluate the prognostic effect of EGFR copy number as measured by FISH separately by treatment arm, i.e., is there a difference in outcome for FISH(+) patients receiving erlotinib compared to FISH (-) patients receiving erlotinib, and similarly is there a difference in outcome for FISH(+) patients receiving pemetrexed compared to FISH (-) patients receiving pemetrexed.
V. To evaluate the prognostic effect of EGFR expression as measured by IHC separately by treatment arm, i.e., is there a difference in outcome for IHC(+) patients receiving erlotinib compared to IHC (-) patients receiving erlotinib, and similarly is there a difference in outcome for IHC(+) patients receiving pemetrexed compared to IHC (-)patients receiving pemetrexed.
VI. To evaluate the prognostic effect of EGFR mutation status separately by treatment arm, i.e., is there a difference in outcome for MUT(+) patients receiving erlotinib compared to MUT(-) patients receiving erlotinib, and similarly is there a difference in outcome for MUT(+) patients receiving pemetrexed compared to MUT(-) patients receiving pemetrexed.
VII. To prospectively test the hypothesis that functionally relevant polymorphisms in the genes encoding for pemetrexed targets, as well as genes encoding for one or more of the key enzymes involved in the transport, activation, and inactivation of pemetrexed, either singly or in combination, play a role in the efficacy and/or toxicity of pemetrexed.
VIII. To prospectively test the hypothesis that functionally relevant polymorphisms in the EGFR gene as well as genes encoding for one or more of the key enzymes involved in the metabolism of erlotinib, either singly or in combination, play a role in the efficacy and/or toxicity of erlotinib.
IX. Evaluate proteomic signatures in blood samples as predictors of survival and response to treatment with erlotinib.
X. To evaluate expression of thymidylate synthase, dihydrofolate reductase, phosphoribosylglycineamide (GAR) formyltransferase, and methylthioadenosine phosphorylase gene expression in tumor samples, as measured by IHC or quantitative polymerase chain reaction, as predictors of survival and response to treatment with pemetrexed.
XI. To evaluate proteomic signatures in blood samples of patients as predictors of response and survival to treatment with erlotinib.
XII. To evaluate the following variables measured in tumor samples, as predictors of response and survival to treatment with pemetrexed: Expression of thymidylate synthase, dihydrofolate reductase and GAR formyltransferase genes methylthioadenosine phosphorylase expression by IHC or quantitative polymerase chain reaction (PCR).
XIII. To evaluate the following variables measured in tumor samples, as predictors of response and survival to treatment with erlotinib: Rat sarcoma (Ras) mutational status, EGFR mutational status and, epithelial to mesenchymal transition (EMT) status (measured by E-cadherin expression and vimentin expression) by IHC.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive erlotinib hydrochloride orally (PO) once daily (QD) on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
ARM II: Patients receive pemetrexed disodium intravenously (IV) over 10 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
After completion of study therapy, patients are followed every 3 months until disease progression and then every 6 months for up to 5 years.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm I (erlotinib hydrochloride)
Patients receive erlotinib hydrochloride PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Erlotinib Hydrochloride
Given PO
Arm II (pemetrexed disodium)
Patients receive pemetrexed disodium IV over 10 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Pemetrexed Disodium
Given IV
Interventions
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Erlotinib Hydrochloride
Given PO
Pemetrexed Disodium
Given IV
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* NSCLC must be confirmed by pathologic examination, either on initial diagnosis or disease recurrence/progression; mixed histology allowed if all components consistent with NSCLC
* Measurable disease, defined as at least one lesion whose longest diameter can be accurately measured as \>= 2.0 cm by conventional techniques or as \>= 1.0 cm by spiral computed tomography (CT); if spiral CT is used, it must be used for both pre- and post- treatment tumor assessments
* Prior radiation therapy is permitted as long as:
* Recovered from the toxic effects of radiation treatment before study entry, except for alopecia
* =\< 25% of bone marrow radiated
* Presence of measurable disease whether in-field disease progression/recurrence or disease outside the treatment fields of radiation port
* Absolute neutrophil count (ANC) \>= 1,500 uL
* Platelet (PLT) \>= 100,000 uL
* Hemoglobin (Hgb) \>= 10 g/dL
* Total bilirubin: within normal institutional limits (WNL) OR direct bilirubin =\< upper limit of normal (ULN)
* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\< 2.5 x ULN
* International normalized ratio (INR) =\< 1.5
* Calculated creatinine clearance \>= 45 mL/min using the Cockcroft-Gault formula
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, or 2
* Negative pregnancy test done =\< 7 days prior to pre-registration, for women of childbearing potential only
* Ability to provide informed consent
* Life expectancy \>= 12 weeks
* Tissue available and willing to submit tissue for central pathology review and EGFR evaluation; performed on original diagnostic/recurrent tissue (preferably paraffin-embedded tissue blocks); if institution unable to release tissue blocks, willing to submit 25 unstained slides (15 sections cut at 5 microns mounted on charged slides and 10 sections cut at 10 microns mounted on uncharged slides)
* Must be previously treated for advanced disease with only 1 chemotherapy regimen which must contain cytotoxic agent(s); adjuvant/neoadjuvant treatment with cytotoxic agent(s) administered \< 12 months (from date chemotherapy was started) prior to pre-registration will be considered as one prior treatment; NOTE: adjuvant/neoadjuvant treatment administered \>= 12 months, use of targeted agents such as monoclonal antibodies prior to pre-registration will NOT be counted as one prior treatment; patient could have had adjuvant/neoadjuvant chemotherapy \>= 12 months and 1 systemic chemotherapy regimen for metastatic or recurrent disease
* Able to take folic acid, vitamin B12 supplementation, and dexamethasone
* Able to permanently discontinue aspirin dose of \>= 1.3 grams/day \>= 10 days before and after pemetrexed treatment
* Fertile patients must use effective contraception
* Able to take folic acid, vitamin B\_12 supplementation, and dexamethasone
* Stable brain metastasis that have been treated with either whole brain radiation therapy or gamma knife surgery and are off steroid treatment for \> 14 days prior to pre-registration, if applicable
* Willingness to return to enrolling institution for treatment and follow-up
Exclusion Criteria
* Pregnant women
* Nursing women
* Men or women of childbearing potential who are unwilling to employ adequate contraception
* Any clinically significant infection, at the treating physician's discretion
* Known human immunodeficiency virus (HIV) positive patients
* Impairment of gastrointestinal (GI) function, inability to swallow pills in the absence of a feeding tube, or GI disease that may significantly alter absorption of oral medications (e.g. ulcerative disease, uncontrolled nausea and vomiting, malabsorption syndromes, bowel obstruction, etc)
* Serious condition that, in the opinion of the investigator, would compromise the patient's ability to complete the study or increase the risk for serious adverse events
* Any of the following prior therapies:
* Prior radiation to \> 25% of bone marrow
* EGFR tyrosine kinase inhibitors
* Pemetrexed
* Chemotherapy =\< 3 weeks prior to pre-registration
* Mitomycin C/nitrosoureas =\< 6 weeks prior to pre-registration
* Immunotherapy =\< 2 weeks prior to pre-registration
* Biologic therapy =\< 2 weeks prior to pre-registration
* Gene therapy =\< 2 weeks prior to pre-registration
* Full field radiation therapy =\< 4 weeks prior to pre-registration
* Limited field radiation therapy =\< 2 weeks prior to pre-registration
* Major surgery (i.e., laparotomy), open biopsy, or significant traumatic injury =\< 4 weeks prior to pre-registration or anticipation of need for major surgical procedure during the course of the study; minor surgery =\< 2 weeks prior to pre-registration; insertion of a vascular access device is not considered major or minor surgery in this regard
* Other chemotherapy, immunotherapy, hormonal therapy, radiotherapy, or any ancillary therapy considered investigational (utilized for a non-Food and Drug Administration \[FDA\]-approved indication and in the context of a research investigation) =\< 4 weeks prior to pre-registration
* Steroid therapy for brain metastasis =\< 14 days prior to pre-registration
* Symptomatic serosal effusion (\>= Common Terminology Criteria for Adverse Events \[CTCAE\] v3.0 grade 2 dyspnea) that is not amenable to drainage prior to pre-registration
* Other invasive solid or hematologic malignancy; exceptions: prior malignancy was diagnosed and definitively treated \>= 5 years previously with no subsequent evidence of recurrence; patients with a history of low-grade (Gleason score =\< 6) localized prostate cancer will be eligible even if diagnosed \< 3 years prior to pre-registration; these patients may continue on medications concomitantly to maintain their disease remission as necessary; patients with carcinoma in situ, regardless of organ involvement, or non-melanoma cutaneous carcinomas are eligible if these were definitively treated \>= 3 years previously with no subsequent evidence of recurrence; Note: patients with breast cancer that was definitively treated \> 5 years earlier but continue to receive aromatase inhibitors are NOT eligible
* Only non-measurable disease, defined as all other lesions, including small lesions whose longest diameter measures \< 2 cm with conventional techniques or \< 1.0 cm with spiral CT, and truly non-measurable lesions, which include the following as per Response Evaluation Criteria In Solid Tumors (RECIST) criteria dated June 1999:
* Bone lesions
* Leptomeningeal disease
* Ascites
* Pleural/pericardial effusion
* Inflammatory breast disease
* Lymphangitis cutis/pulmonis
* Abdominal masses that are not confirmed and followed by imaging techniques
* Cystic lesions
* Single disease site in prior radiation field
* Any of the following concurrent severe and/or uncontrolled medical conditions:
* Angina pectoris
* History of congestive heart failure =\< 3 months prior to pre-registration, unless ejection fraction \> 40%
* Myocardial infarction =\< 6 months prior to pre-registration
* Cardiac arrhythmia
* Diabetes mellitus
* Hypertension
* Any other severe underlying diseases which are, in the judgment of the investigator, inappropriate for entry into this study
* Respiratory symptoms \> CTCAE grade 1
18 Years
ALL
No
Sponsors
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Cancer and Leukemia Group B
NETWORK
Eastern Cooperative Oncology Group
NETWORK
NCIC Clinical Trials Group
NETWORK
SWOG Cancer Research Network
NETWORK
National Cancer Institute (NCI)
NIH
Responsible Party
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Principal Investigators
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Alex Adjei
Role: PRINCIPAL_INVESTIGATOR
Alliance for Clinical Trials in Oncology
Locations
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Mayo Clinic in Arizona
Scottsdale, Arizona, United States
Sparks Regional Medical Center
Fort Smith, Arkansas, United States
Kaiser Permanente-Deer Valley Medical Center
Antioch, California, United States
Kaiser Permanente-Fremont
Fremont, California, United States
Fremont - Rideout Cancer Center
Marysville, California, United States
Kaiser Permanente-Oakland
Oakland, California, United States
Valley Care Health System - Pleasanton
Pleasanton, California, United States
Kaiser Permanente-Redwood City
Redwood City, California, United States
Kaiser Permanente-Richmond
Richmond, California, United States
Kaiser Permanente-Roseville
Roseville, California, United States
University of California Davis Comprehensive Cancer Center
Sacramento, California, United States
Kaiser Permanente-South Sacramento
Sacramento, California, United States
Kaiser Permanente - Sacramento
Sacramento, California, United States
Kaiser Permanente-San Francisco
San Francisco, California, United States
Kaiser Permanente-Santa Teresa-San Jose
San Jose, California, United States
Kaiser Permanente San Leandro
San Leandro, California, United States
Kaiser Permanente-San Rafael
San Rafael, California, United States
Kaiser Permanente Medical Center - Santa Clara
Santa Clara, California, United States
Kaiser Permanente-Santa Rosa
Santa Rosa, California, United States
Kaiser Permanente-South San Francisco
South San Francisco, California, United States
Kaiser Permanente-Stockton
Stockton, California, United States
Tahoe Forest Cancer Center
Truckee, California, United States
Kaiser Permanente Medical Center-Vacaville
Vacaville, California, United States
Kaiser Permanente-Vallejo
Vallejo, California, United States
Kaiser Permanente-Walnut Creek
Walnut Creek, California, United States
The Medical Center of Aurora
Aurora, Colorado, United States
Boulder Community Hospital
Boulder, Colorado, United States
Penrose-Saint Francis Healthcare
Colorado Springs, Colorado, United States
Porter Adventist Hospital
Denver, Colorado, United States
Exempla Saint Joseph Hospital
Denver, Colorado, United States
Presbyterian - Saint Lukes Medical Center - Health One
Denver, Colorado, United States
Rose Medical Center
Denver, Colorado, United States
Colorado Cancer Research Program CCOP
Denver, Colorado, United States
Swedish Medical Center
Englewood, Colorado, United States
Saint Mary's Hospital and Regional Medical Center
Grand Junction, Colorado, United States
North Colorado Medical Center
Greeley, Colorado, United States
Saint Anthony Hospital
Lakewood, Colorado, United States
Sky Ridge Medical Center
Lone Tree, Colorado, United States
Longmont United Hospital
Longmont, Colorado, United States
McKee Medical Center
Loveland, Colorado, United States
Saint Mary Corwin Medical Center
Pueblo, Colorado, United States
North Suburban Medical Center
Thornton, Colorado, United States
SCL Health Lutheran Medical Center
Wheat Ridge, Colorado, United States
Bristol Hospital
Bristol, Connecticut, United States
Middlesex Hospital
Middletown, Connecticut, United States
Lynn Regional Cancer Center - West
Boca Raton, Florida, United States
Boca Raton Comprehensive Cancer Center
Boca Raton, Florida, United States
Mayo Clinic in Florida
Jacksonville, Florida, United States
MacNeal Hospital and Cancer Center
Berwyn, Illinois, United States
Saint Joseph Medical Center
Bloomington, Illinois, United States
Illinois CancerCare-Bloomington
Bloomington, Illinois, United States
Graham Hospital Association
Canton, Illinois, United States
Illinois CancerCare-Canton
Canton, Illinois, United States
Illinois CancerCare-Carthage
Carthage, Illinois, United States
Memorial Hospital
Carthage, Illinois, United States
Hematology and Oncology Associates
Chicago, 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
Eureka Hospital
Eureka, Illinois, United States
Illinois CancerCare-Eureka
Eureka, Illinois, United States
Galesburg Cottage Hospital
Galesburg, Illinois, United States
Illinois CancerCare Galesburg
Galesburg, Illinois, United States
Illinois CancerCare-Cottage
Galesburg, Illinois, United States
Illinois CancerCare-Havana
Havana, Illinois, United States
Mason District Hospital
Havana, Illinois, United States
Hematology Oncology Associates of Illinois-Highland Park
Highland Park, Illinois, United States
Hopedale Medical Complex - Hospital
Hopedale, Illinois, United States
Midwest Center for Hematology Oncology
Joliet, Illinois, United States
Illinois CancerCare-Kewanee Clinic
Kewanee, Illinois, United States
NorthShore Hematology Oncology-Libertyville
Libertyville, Illinois, United States
Illinois CancerCare-Macomb
Macomb, Illinois, United States
Mcdonough District Hospital
Macomb, Illinois, United States
Loyola University Medical Center
Maywood, Illinois, United States
Holy Family Medical Center
Monmouth, Illinois, United States
Illinois CancerCare-Monmouth
Monmouth, Illinois, United States
DuPage Medical Group-Ogden
Naperville, Illinois, United States
Illinois Cancer Specialists-Niles
Niles, Illinois, United States
Bromenn Regional Medical Center
Normal, Illinois, United States
Community Cancer Center Foundation
Normal, Illinois, United States
Illinois CancerCare-Community Cancer Center
Normal, Illinois, United States
Illinois CancerCare-Ottawa Clinic
Ottawa, Illinois, United States
Ottawa Regional Hospital and Healthcare Center
Ottawa, Illinois, United States
Illinois CancerCare-Pekin
Pekin, Illinois, United States
Pekin Cancer Treatment Center
Pekin, Illinois, United States
Pekin Hospital
Pekin, Illinois, United States
Methodist Medical Center of Illinois
Peoria, Illinois, United States
Proctor Hospital
Peoria, Illinois, United States
OSF Saint Francis Medical Center Radiation Oncology Service at the Central Illinois Comprehensive CC
Peoria, Illinois, United States
Illinois CancerCare-Peoria
Peoria, Illinois, United States
Illinois Oncology Research Association CCOP
Peoria, Illinois, United States
OSF Saint Francis Medical Center
Peoria, Illinois, United States
Illinois CancerCare-Peru
Peru, Illinois, United States
Illinois Valley Hospital
Peru, Illinois, United States
Illinois CancerCare-Princeton
Princeton, Illinois, United States
Perry Memorial Hospital
Princeton, Illinois, United States
Hematology Oncology Associates of Illinois - Skokie
Skokie, Illinois, United States
Illinois CancerCare-Spring Valley
Spring Valley, Illinois, United States
Saint Margaret's Hospital
Spring Valley, Illinois, United States
Memorial Medical Center
Springfield, Illinois, United States
Franciscan St. Francis Health-Beech Grove
Beech Grove, Indiana, United States
Reid Hospital and Health Care Services
Richmond, Indiana, United States
McFarland Clinic PC-William R Bliss Cancer Center
Ames, Iowa, United States
Hematology Oncology Associates-Quad Cities
Bettendorf, Iowa, United States
Cedar Rapids Oncology Association
Cedar Rapids, Iowa, United States
Mercy Hospital
Cedar Rapids, Iowa, United States
Oncology Associates at Mercy Medical Center
Cedar Rapids, Iowa, United States
Medical Oncology and Hematology Associates-West Des Moines
Clive, Iowa, United States
Genesis Medical Center - East Campus
Davenport, Iowa, United States
Genesis Medical Center - West Campus
Davenport, Iowa, United States
Mercy Capitol
Des Moines, Iowa, United States
Iowa Methodist Medical Center
Des Moines, Iowa, United States
Iowa Oncology Research Association CCOP
Des Moines, Iowa, United States
Medical Oncology and Hematology Associates-Des Moines
Des Moines, Iowa, United States
Medical Oncology and Hematology Associates-Laurel
Des Moines, Iowa, United States
Mercy Medical Center - Des Moines
Des Moines, Iowa, United States
Iowa Lutheran Hospital
Des Moines, Iowa, United States
Siouxland Regional Cancer Center
Sioux City, Iowa, United States
Mercy Medical Center-Sioux City
Sioux City, Iowa, United States
Saint Luke's Regional Medical Center
Sioux City, Iowa, United States
Covenant Medical Center
Waterloo, Iowa, United States
Hospital District Sixth of Harper County
Anthony, Kansas, United States
Menorah Medical Center
Overland Park, Kansas, United States
Saint Luke's South Hospital
Overland Park, Kansas, United States
Shawnee Mission Medical Center-KCCC
Shawnee Mission, Kansas, United States
Stormont-Vail Regional Health Center
Topeka, Kansas, United States
Greater Baltimore Medical Center
Baltimore, Maryland, United States
The Memorial Hospital at Easton
Easton, Maryland, United States
Cancer Trials Support Unit
Rockville, Maryland, United States
Boston Medical Center
Boston, Massachusetts, United States
Steward Saint Elizabeth's Medical Center
Brighton, Massachusetts, United States
Cape Cod Hospital
Hyannis, Massachusetts, United States
Bixby Medical Center
Adrian, Michigan, United States
Hickman Cancer Center
Adrian, Michigan, United States
Saint Joseph Mercy Hospital
Ann Arbor, Michigan, United States
Michigan Cancer Research Consortium CCOP
Ann Arbor, Michigan, United States
Bronson Battle Creek
Battle Creek, Michigan, United States
Spectrum Health Big Rapids Hospital
Big Rapids, Michigan, United States
Oakwood Hospital and Medical Center
Dearborn, Michigan, United States
Saint John Hospital and Medical Center
Detroit, Michigan, United States
Hurley Medical Center
Flint, Michigan, United States
Genesys Regional Medical Center-West Flint Campus
Flint, Michigan, United States
Grand Rapids Clinical Oncology Program
Grand Rapids, Michigan, United States
Mercy Health Saint Mary's
Grand Rapids, Michigan, United States
Spectrum Health at Butterworth Campus
Grand Rapids, Michigan, United States
Allegiance Health
Jackson, Michigan, United States
Sparrow Hospital
Lansing, Michigan, United States
Saint Mary Mercy Hospital
Livonia, Michigan, United States
Mercy Memorial Hospital
Monroe, Michigan, United States
Toledo Clinic Cancer Centers-Monroe
Monroe, Michigan, United States
Mercy Health Mercy Campus
Muskegon, Michigan, United States
Saint Joseph Mercy Oakland
Pontiac, Michigan, United States
Saint Joseph Mercy Port Huron
Port Huron, Michigan, United States
Saint Mary's of Michigan
Saginaw, Michigan, United States
Munson Medical Center
Traverse City, Michigan, United States
Saint John Macomb-Oakland Hospital
Warren, Michigan, United States
Metro Health Hospital
Wyoming, Michigan, United States
Essentia Health Cancer Center
Duluth, Minnesota, United States
Essentia Health Saint Mary's Medical Center
Duluth, Minnesota, United States
Miller-Dwan Hospital
Duluth, Minnesota, United States
Hutchinson Area Health Care
Hutchinson, Minnesota, United States
Meeker County Memorial Hospital
Litchfield, Minnesota, United States
Saint John's Hospital - Healtheast
Maplewood, Minnesota, United States
Minnesota Cooperative Group Outreach Program
Minneapolis, Minnesota, United States
Virginia Piper Cancer Institute
Minneapolis, Minnesota, United States
Hennepin County Medical Center
Minneapolis, Minnesota, United States
Mayo Clinic
Rochester, Minnesota, United States
Regions Hospital
Saint Paul, Minnesota, United States
Rice Memorial Hospital
Willmar, Minnesota, United States
Truman Medical Center
Kansas City, Missouri, United States
Saint Luke's Cancer Institute
Kansas City, Missouri, United States
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, United States
Saint Joseph Health Center
Kansas City, Missouri, United States
North Kansas City Hospital
Kansas City, Missouri, United States
Research Medical Center
Kansas City, Missouri, United States
Saint Luke's East - Lee's Summit
Lee's Summit, Missouri, United States
Liberty Hospital
Liberty, Missouri, United States
Liberty Radiation Oncology Center
Liberty, Missouri, United States
Heartland Regional Medical Center
Saint Joseph, Missouri, United States
Saint Louis University Hospital
St Louis, Missouri, United States
Missouri Baptist Medical Center
St Louis, Missouri, United States
Center for Cancer Care and Research
St Louis, Missouri, United States
Montana Cancer Consortium NCORP
Billings, Montana, United States
Northern Rockies Radiation Oncology Center
Billings, Montana, United States
Saint Vincent Healthcare
Billings, Montana, United States
Frontier Cancer Center and Blood Institute-Billings
Billings, Montana, United States
Billings Clinic Cancer Center
Billings, Montana, United States
Bozeman Deaconess Cancer Center
Bozeman, Montana, United States
Bozeman Deaconess Hospital
Bozeman, Montana, United States
Saint James Community Hospital and Cancer Treatment Center
Butte, Montana, United States
Berdeaux, Donald MD (UIA Investigator)
Great Falls, Montana, United States
Great Falls Clinic
Great Falls, Montana, United States
Northern Montana Hospital
Havre, Montana, United States
Saint Peter's Community Hospital
Helena, Montana, United States
Glacier Oncology PLLC
Kalispell, Montana, United States
Kalispell Medical Oncology
Kalispell, Montana, United States
Kalispell Regional Medical Center
Kalispell, Montana, United States
Community Medical Hospital
Missoula, Montana, United States
Montana Cancer Specialists
Missoula, Montana, United States
Saint Patrick Hospital - Community Hospital
Missoula, Montana, United States
Guardian Oncology and Center for Wellness
Missoula, Montana, United States
CHI Health Good Samaritan
Kearney, Nebraska, United States
Veterans Adminstration New Jersey Health Care System
East Orange, New Jersey, United States
Hunterdon Medical Center
Flemington, New Jersey, United States
Fox Chase Cancer Center at Virtua Memorial Hospital of Burlington County
Mount Holly, New Jersey, United States
Riverview Medical Center/Booker Cancer Center
Red Bank, New Jersey, United States
Virtua West Jersey Hospital Voorhees
Voorhees Township, New Jersey, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
University of Rochester
Rochester, New York, United States
State University of New York Upstate Medical University
Syracuse, New York, United States
Syracuse Veterans Administration Medical Center
Syracuse, New York, United States
Wayne Memorial Hospital
Goldsboro, North Carolina, United States
Margaret R Pardee Memorial Hospital
Hendersonville, North Carolina, United States
Rutherford Hospital
Rutherfordton, North Carolina, United States
Southeast Cancer Consortium-Upstate NCORP
Winston-Salem, North Carolina, United States
Mid Dakota Clinic
Bismarck, North Dakota, United States
Saint Alexius Medical Center
Bismarck, North Dakota, United States
Sanford Bismarck Medical Center
Bismarck, North Dakota, United States
Altru Cancer Center
Grand Forks, North Dakota, United States
Toledo Clinic Cancer Centers-Bowling Green
Bowling Green, Ohio, United States
North Coast Cancer Care-Clyde
Clyde, Ohio, United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
Grandview Hospital
Dayton, Ohio, United States
Good Samaritan Hospital - Dayton
Dayton, Ohio, United States
Miami Valley Hospital
Dayton, Ohio, United States
Samaritan North Health Center
Dayton, Ohio, United States
Dayton CCOP
Dayton, Ohio, United States
Hematology Oncology Center Incorporated
Elyria, Ohio, United States
Blanchard Valley Hospital
Findlay, Ohio, United States
Atrium Medical Center-Middletown Regional Hospital
Franklin, Ohio, United States
Wayne Hospital
Greenville, Ohio, United States
Kettering Medical Center
Kettering, Ohio, United States
Lima Memorial Hospital
Lima, Ohio, United States
Saint Luke's Hospital
Maumee, Ohio, United States
Toledo Clinic Cancer Centers-Maumee
Maumee, Ohio, United States
Toledo Radiation Oncology at Northwest Ohio Onocolgy Center
Maumee, Ohio, United States
Saint Charles Hospital
Oregon, Ohio, United States
Toledo Clinic Cancer Centers-Oregon
Oregon, Ohio, United States
North Coast Cancer Care
Sandusky, Ohio, United States
Flower Hospital
Sylvania, Ohio, United States
Mercy Hospital of Tiffin
Tiffin, Ohio, United States
The Toledo Hospital/Toledo Children's Hospital
Toledo, Ohio, United States
Saint Vincent Mercy Medical Center
Toledo, Ohio, United States
University of Toledo
Toledo, Ohio, United States
Toledo Community Hospital Oncology Program CCOP
Toledo, Ohio, United States
Mercy Saint Anne Hospital
Toledo, Ohio, United States
Toledo Clinic Cancer Centers-Toledo
Toledo, Ohio, United States
Upper Valley Medical Center
Troy, Ohio, United States
Fulton County Health Center
Wauseon, Ohio, United States
Clinton Memorial Hospital
Wilmington, Ohio, United States
Greene Memorial Hospital
Xenia, Ohio, United States
Geisinger Medical Center
Danville, Pennsylvania, United States
Geisinger Medical Center-Cancer Center Hazleton
Hazleton, Pennsylvania, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States
Mercy Hospital
Scranton, Pennsylvania, United States
Scranton Hematology Oncology
Scranton, Pennsylvania, United States
Geisinger Medical Group
State College, Pennsylvania, United States
Mount Nittany Medical Center
State College, Pennsylvania, United States
Geisinger Wyoming Valley/Henry Cancer Center
Wilkes-Barre, Pennsylvania, United States
AnMed Health Hospital
Anderson, South Carolina, United States
Spartanburg Medical Center
Spartanburg, South Carolina, United States
Rapid City Regional Hospital
Rapid City, South Dakota, United States
Danville Regional Medical Center
Danville, Virginia, United States
Fredericksburg Oncology Inc
Fredericksburg, Virginia, United States
Memorial Hospital Of Martinsville
Martinsville, Virginia, United States
Virginia Commonwealth University/Massey Cancer Center
Richmond, Virginia, United States
Rocky Mountain Oncology
Casper, Wyoming, United States
Welch Cancer Center
Sheridan, Wyoming, United States
Allan Blair Cancer Centre
Regina, Saskatchewan, Canada
Countries
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Other Identifiers
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NCI-2009-00663
Identifier Type: REGISTRY
Identifier Source: secondary_id
CDR0000612010
Identifier Type: -
Identifier Source: secondary_id
NCCTG-N0723
Identifier Type: -
Identifier Source: secondary_id
CALGB-30802
Identifier Type: -
Identifier Source: secondary_id
CAN-NCIC-BRC4
Identifier Type: -
Identifier Source: secondary_id
N0723
Identifier Type: OTHER
Identifier Source: secondary_id
N0723
Identifier Type: OTHER
Identifier Source: secondary_id
NCI-2009-00663
Identifier Type: -
Identifier Source: org_study_id
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