Clofarabine or Daunorubicin Hydrochloride and Cytarabine Followed By Decitabine or Observation in Treating Older Patients With Newly Diagnosed Acute Myeloid Leukemia
Phase III Randomized Trial of Clofarabine as Induction and Post-Remission Therapy vs. Standard Daunorubicin &Amp; Cytarabine Induction and Intermediate Dose Cytarabine Post-Remission Therapy, Followed by Decitabine Maintenance vs. Observation in Newly-Diagnosed Acute Myeloid Leukemia in Older Adults (Age >/= 60 Years)
4 other identifiers
interventional
727
3 countries
269
Brief Summary
This randomized phase III trial studies clofarabine to see how well it works compared with daunorubicin hydrochloride and cytarabine when followed by decitabine or observation in treating older patients with newly diagnosed acute myeloid leukemia. Drugs used in chemotherapy, such as clofarabine, daunorubicin hydrochloride, cytarabine, and decitabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. It is not yet known which chemotherapy regimen is more effective in treating acute myeloid leukemia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Feb 2011
Longer than P75 for phase_3
269 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
Study Start
First participant enrolled
February 4, 2011
CompletedFirst Submitted
Initial submission to the registry
March 11, 2014
CompletedFirst Posted
Study publicly available on registry
March 12, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 22, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 21, 2022
CompletedResults Posted
Study results publicly available
March 9, 2023
CompletedDecember 13, 2024
November 1, 2024
10.1 years
March 11, 2014
November 7, 2022
November 25, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall Survival
Overall survival is defined as the time from randomization to death or date last known alive.
Assessed every 3 months for 4 years and then every 6 months for 1 year
Secondary Outcomes (3)
Proportion of Patients With Complete Remission
Assessed every 3 months for 4 years and then every 6 months for 1 year
Overall Survival by Donor Status
Assessed every 3 months for 4 years and then every 6 months for 1 year
Disease-free Survival for Maintenance
Assessed every 3 months for 4 years and then every 6 months for 1 year
Other Outcomes (12)
Expression and Methylation Profiling
Baseline of maintenance treatment
Relapse After Decitabine Maintenance by Epigenetic Signature of Normal Bone Marrow
Assessed every 3 months for 4 years and then every 6 months for 1 year
Complete Remission Rate by ABC-transporter P-glycoprotein (Pgp)
Assessed every 3 months for 4 years and then every 6 months for 1 year
- +9 more other outcomes
Study Arms (2)
A (Induction:daunorubicin/cytarabine; consolidation:cytarabine; maintenance:observation/transplant)
ACTIVE COMPARATORSee Detailed Description
B (Induction: clofarabine; Consolidation: clofarabine; Maintenance: decitabine or transplant)
EXPERIMENTALSee Detailed Description
Interventions
Given IV
Given IV
Given IV
Given IV
Undergo clinical observation
Patients with an HLA-identical donor proceed to allogeneic stem cell transplantation.
Eligibility Criteria
You may qualify if:
- Sexually active males must be strongly advised to use an accepted and effective method of contraception
- Aspartate aminotransferase (AST), alanine aminotransferase (ALT), total bilirubin =\< grade 1
- Newly-diagnosed AML patients according to World Health Organization (WHO) classification who are considered candidates for intensive chemotherapy based upon examination of peripheral blood or bone marrow aspirate specimens or touch preparations of the bone marrow biopsy obtained within two weeks prior to randomization; a bone marrow aspirate is required for enrollment; however, on occasion there is discordance between percentage of myeloblasts on the differential of the peripheral blood or aspirate; the peripheral blood criteria are sufficient for diagnosis; confirmatory immunophenotyping will be performed centrally
- ECOG performance status (PS) 0-3 (restricted to ECOG PS 0-2 if \>= 70 years of age)
- Patients with secondary AML are eligible for enrollment onto the trial; secondary AML is defined as AML that has developed in a person with a history of antecedent blood count abnormalities, or myelodysplastic syndrome (MDS), or a myeloproliferative disorder (excluding chronic myeloid leukemia); or a history of prior chemotherapy or radiation therapy for a disease other than AML
- Total serum bilirubin =\< 1.5 times upper limit of normal (ULN) (=\< grade 1); if total bilirubin is 2 to 3 mg/dL, but direct bilirubin is normal, then the patient will be considered eligible
- Patients with a serum creatinine \> 1 are eligible if they have a calculated glomerular filtration rate (GFR) of \>= 60 ml/min (i.e. class I or class II chronic kidney disease ) using the Modification of Diet in Renal Disease (MDRD) formula
- Note: Daily creatinine and MDRD formula are only for the 1st induction cycle
- Cardiac ejection fraction \>= 45% or within institutional normal limits; a nuclear medicine gated blood pool examination is preferred; a two-dimensional (2-D) echocardiogram (ECHO) scan is acceptable if a calculated ejection fraction is obtained and follow-up measurement of the cardiac ejection fraction will also be performed by echocardiography; measurement of cardiac ejection fraction should be within two weeks prior to receiving treatment
- NOTE: when a multi gated acquisition scan (MUGA) or echocardiogram cannot be obtained due to weekend or holiday, then patients may be enrolled provided there is no history of significant cardiovascular disease and a measurement of cardiac ejection fraction will be performed within 5 days of study enrollment
- Patients with suspected central nervous system (CNS) involvement should undergo lumbar puncture
- Cytogenetic analysis must be performed from diagnostic bone marrow (preferred) or if adequate number of circulating blasts (\>10\^9/l) from peripheral blood
- HLA typing should be performed at registration, if possible
- Diagnostic bone marrow and peripheral blood specimens must be submitted for immunophenotyping and selected molecular testing
You may not qualify if:
- Concurrent active malignancy for which they are receiving treatment (other than myelodysplastic syndromes \[MDS\])
- Active, uncontrolled infection
- Acute promyelocytic leukemia (APL) confirmed either by the presence of t(15;17)(q22;q21) or promyelocytic leukemia (PML)/retinoic acid receptor (RAR) alpha transcripts
- Blastic transformation of chronic myelogenous leukemia
- Prior therapy of MDS with decitabine, low-dose cytarabine, or azacitidine
- Prior chemotherapy for AML with the exception of hydroxyurea for increased blast count or leukapheresis for leukocytosis
- Documented CNS involvement
- Previous treatment for antecedent hematological disorders (AHD) with 5-azacitidine, decitabine, or low dose cytarabine
- Human immunodeficiency virus (HIV) infection
- NOTE: All patients achieving complete remission (CR) or complete remission with incomplete blood count recovery (CRi) will receive consolidation when fit
- NOTE: Patients proceeding to transplant are allowed up to one cycle of consolidation treatment
- Consolidation cycle 1 must commence within sixty days of the bone marrow aspirate and biopsy that confirmed the presence of a CR or CRi
- Patients must have achieved a CR or CRi (or morphologic leukemia-free state for those patients proceeding to Arm G transplant)
- Patients who have achieved a CR or CRi must have maintained peripheral blood evidence of a CR or CRi
- ECOG performance status of 0-2
- +26 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- ECOG-ACRIN Cancer Research Grouplead
- National Cancer Institute (NCI)collaborator
Study Sites (269)
University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
Mayo Clinic in Arizona
Scottsdale, Arizona, 85259, United States
Arizona Cancer Center at University Medical Center North
Tucson, Arizona, 85719, United States
University of Arizona Health Sciences Center
Tucson, Arizona, 85724, United States
The Medical Center of Aurora
Aurora, Colorado, 80012, United States
Boulder Community Hospital
Boulder, Colorado, 80301, United States
Penrose-Saint Francis Healthcare
Colorado Springs, Colorado, 80907, United States
Saint Anthony Central Hospital
Denver, Colorado, 80204, United States
Porter Adventist Hospital
Denver, Colorado, 80210, United States
Exempla Saint Joseph Hospital
Denver, Colorado, 80218, United States
Presbyterian - Saint Lukes Medical Center - Health One
Denver, Colorado, 80218, United States
Rose Medical Center
Denver, Colorado, 80220, United States
Colorado Cancer Research Program CCOP
Denver, Colorado, 80224-2522, United States
Swedish Medical Center
Englewood, Colorado, 80110, United States
North Colorado Medical Center
Greeley, Colorado, 80631, United States
Littleton Adventist Hospital
Littleton, Colorado, 80122, United States
Sky Ridge Medical Center
Lone Tree, Colorado, 80124, United States
Longmont United Hospital
Longmont, Colorado, 80501, United States
McKee Medical Center
Loveland, Colorado, 80539, United States
Parker Adventist Hospital
Parker, Colorado, 80138, United States
Saint Mary Corwin Medical Center
Pueblo, Colorado, 81004, United States
North Suburban Medical Center
Thornton, Colorado, 80229, United States
Exempla Lutheran Medical Center
Wheat Ridge, Colorado, 80033, United States
Saint Francis Hospital and Medical Center
Hartford, Connecticut, 06105, United States
The Hospital of Central Connecticut
New Britain, Connecticut, 06050, United States
Beebe Medical Center
Lewes, Delaware, 19958, United States
Christiana Care Health System-Christiana Hospital
Newark, Delaware, 19718, United States
University of Florida
Gainesville, Florida, 32610, United States
Mayo Clinic in Florida
Jacksonville, Florida, 32224-9980, United States
Florida Hospital
Orlando, Florida, 32803, United States
Piedmont Hospital
Atlanta, Georgia, 30309, United States
Atlanta Regional CCOP
Atlanta, Georgia, 30342, United States
Northside Hospital
Atlanta, Georgia, 30342, United States
Saint Joseph's Hospital of Atlanta
Atlanta, Georgia, 30342, United States
Georgia Regents University
Augusta, Georgia, 30912, United States
Well Star Cobb Hospital
Austell, Georgia, 30106, United States
John B Amos Cancer Center
Columbus, Georgia, 31904, United States
Dekalb Medical Center
Decatur, Georgia, 30033, United States
Piedmont Fayette Hospital
Fayetteville, Georgia, 30214, United States
Gwinnett Medical Center
Lawrenceville, Georgia, 30045, United States
Wellstar Kennestone Hospital
Marietta, Georgia, 30060, United States
Southern Regional Medical Center
Riverdale, Georgia, 30274, United States
Harbin Clinic Medical Oncology and Clinical Research
Rome, Georgia, 30165, United States
Oncare Hawaii Inc-POB II
Honolulu, Hawaii, 96813, United States
Queen's Medical Center
Honolulu, Hawaii, 96813, United States
Straub Clinic and Hospital
Honolulu, Hawaii, 96813, United States
University of Hawaii
Honolulu, Hawaii, 96813, United States
OnCare Hawaii-Liliha
Honolulu, Hawaii, 96817-3169, United States
Kuakini Medical Center
Honolulu, Hawaii, 96817, United States
Oncare Hawaii Inc-Kuakini
Honolulu, Hawaii, 96817, United States
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, 96826, United States
Castle Medical Center
Kailua, Hawaii, 96734, United States
Wilcox Memorial Hospital and Kauai Medical Clinic
Lihue, Hawaii, 96766, United States
Kapiolani Medical Center at Pali Momi
‘Aiea, Hawaii, 96701, United States
Oncare Hawaii Inc - Kapiolani Medical Center at Pali Momi
‘Aiea, Hawaii, 96701, United States
Saint Alphonsus Regional Medical Center
Boise, Idaho, 83706, United States
Saint Anthony's Health
Alton, Illinois, 62002, United States
Illinois CancerCare-Bloomington
Bloomington, Illinois, 61701, United States
Saint Joseph Medical Center
Bloomington, Illinois, 61701, United States
Graham Hospital Association
Canton, Illinois, 61520, United States
Illinois CancerCare-Canton
Canton, Illinois, 61520, United States
Illinois CancerCare-Carthage
Carthage, Illinois, 62321, United States
Memorial Hospital
Carthage, Illinois, 62321, United States
Mount Sinai Hospital Medical Center
Chicago, Illinois, 60608, United States
Hematology and Oncology Associates
Chicago, Illinois, 60611, United States
Northwestern University
Chicago, Illinois, 60611, United States
University of Illinois
Chicago, Illinois, 60612, United States
Decatur Memorial Hospital
Decatur, Illinois, 62526, United States
Eureka Hospital
Eureka, Illinois, 61530, United States
Illinois CancerCare-Eureka
Eureka, Illinois, 61530, United States
Illinois CancerCare Galesburg
Galesburg, Illinois, 61401, United States
Western Illinois Cancer Treatment Center
Galesburg, Illinois, 61401, United States
Illinois CancerCare-Havana
Havana, Illinois, 62644, United States
Mason District Hospital
Havana, Illinois, 62644, United States
Hematology Oncology Associates of Illinois-Highland Park
Highland Park, Illinois, 60035, United States
Hinsdale Hematology Oncology Associates Incorporated
Hinsdale, Illinois, 60521, United States
Presence Saint Mary's Hospital
Kankakee, Illinois, 60901, United States
Illinois CancerCare-Kewanee Clinic
Kewanee, Illinois, 61443, United States
North Shore Hematology Oncology
Libertyville, Illinois, 60048, United States
Illinois CancerCare-Macomb
Macomb, Illinois, 61455, United States
Mcdonough District Hospital
Macomb, Illinois, 61455, United States
Loyola University Medical Center
Maywood, Illinois, 60153, United States
Holy Family Medical Center
Monmouth, Illinois, 61462, United States
Illinois CancerCare-Monmouth
Monmouth, Illinois, 61462, United States
Illinois Cancer Specialists-Niles
Niles, Illinois, 60714, United States
Bromenn Regional Medical Center
Normal, Illinois, 61761, United States
Community Cancer Center Foundation
Normal, Illinois, 61761, United States
Illinois CancerCare-Community Cancer Center
Normal, Illinois, 61761, United States
Illinois CancerCare-Ottawa Clinic
Ottawa, Illinois, 61350, United States
Ottawa Regional Hospital and Healthcare Center
Ottawa, Illinois, 61350, United States
Pekin Cancer Treatment Center
Pekin, Illinois, 61554, United States
Illinois CancerCare-Pekin
Pekin, Illinois, 61603, United States
Methodist Medical Center of Illinois
Peoria, Illinois, 61603, United States
Proctor Hospital
Peoria, Illinois, 61614, United States
Illinois CancerCare-Peoria
Peoria, Illinois, 61615, United States
Illinois Oncology Research Association CCOP
Peoria, Illinois, 61615, United States
OSF Saint Francis Medical Center
Peoria, Illinois, 61637, United States
Illinois CancerCare-Peru
Peru, Illinois, 61354, United States
Illinois Valley Hospital
Peru, Illinois, 61354, United States
Illinois CancerCare-Princeton
Princeton, Illinois, 61356, United States
Perry Memorial Hospital
Princeton, Illinois, 61356, United States
Swedish American Hospital
Rockford, Illinois, 61104, United States
Hematology Oncology Associates of Illinois - Skokie
Skokie, Illinois, 60076, United States
Illinois CancerCare-Spring Valley
Spring Valley, Illinois, 61362, United States
Memorial Medical Center
Springfield, Illinois, 62781-0001, United States
Saint Francis Hospital and Health Centers
Beech Grove, Indiana, 46107, United States
Fort Wayne Medical Oncology and Hematology Inc - State Boulevard
Fort Wayne, Indiana, 46845, United States
Franciscan St. Francis Health
Indianapolis, Indiana, 46237, United States
Reid Hospital and Health Care Services
Richmond, Indiana, 47374, United States
McFarland Clinic
Ames, Iowa, 50010, United States
Siouxland Hematology Oncology Associates
Sioux City, Iowa, 51101, United States
Mercy Medical Center-Sioux City
Sioux City, Iowa, 51104, United States
Saint Luke's Regional Medical Center
Sioux City, Iowa, 51104, United States
University of Kentucky
Lexington, Kentucky, 40536, United States
Norton Health Care Pavilion - Downtown
Louisville, Kentucky, 40202, United States
Ochsner Clinic Foundation-Baton Rouge
Baton Rouge, Louisiana, 70809, United States
Ochsner Baptist Medical Center
New Orleans, Louisiana, 70115, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121, United States
Harold Alfond Center for Cancer Care
Augusta, Maine, 04330, United States
Eastern Maine Medical Center
Bangor, Maine, 04401, United States
Johns Hopkins University
Baltimore, Maryland, 21287-8936, United States
Walter Reed National Military Medical Center
Bethesda, Maryland, 20889-5600, United States
Union Hospital of Cecil County
Elkton, Maryland, 21921, United States
Tufts Medical Center
Boston, Massachusetts, 02111, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Caritas Saint Elizabeth's Medical Center
Brighton, Massachusetts, 02135-2997, United States
Baystate Medical Center
Springfield, Massachusetts, 01199, United States
Saint Joseph Mercy Hospital
Ann Arbor, Michigan, 48106-0995, United States
Michigan Cancer Research Consortium Community Clinical Oncology Program
Ann Arbor, Michigan, 48106, United States
Bronson Battle Creek
Battle Creek, Michigan, 49017, United States
Mecosta County Medical Center
Big Rapids, Michigan, 49307, United States
Oakwood Hospital
Dearborn, Michigan, 48124, United States
Wayne State University
Detroit, Michigan, 48202, United States
Saint John Hospital and Medical Center
Detroit, Michigan, 48236, United States
Hurley Medical Center
Flint, Michigan, 48502, United States
Genesys Hurley Cancer Institute
Flint, Michigan, 48503, United States
Genesys Regional Medical Center-West Flint Campus
Flint, Michigan, 48532, United States
Genesys Regional Medical Center
Grand Blanc, Michigan, 48439, United States
Grand Rapids Clinical Oncology Program
Grand Rapids, Michigan, 49503, United States
Saint Mary's Health Care
Grand Rapids, Michigan, 49503, United States
Spectrum Health at Butterworth Campus
Grand Rapids, Michigan, 49503, United States
Allegiance Health
Jackson, Michigan, 49201, United States
Borgess Medical Center
Kalamazoo, Michigan, 49001, United States
Bronson Methodist Hospital
Kalamazoo, Michigan, 49007, United States
West Michigan Cancer Center
Kalamazoo, Michigan, 49007, United States
Sparrow Hospital
Lansing, Michigan, 48912, United States
Saint Mary Mercy Hospital
Livonia, Michigan, 48154, United States
Mercy Health Partners-Mercy Campus
Muskegon, Michigan, 49444, United States
Saint Joseph Mercy Oakland
Pontiac, Michigan, 48341-2985, United States
Saint Joseph Mercy Port Huron
Port Huron, Michigan, 48060, United States
Spectrum Health Reed City Hospital
Reed City, Michigan, 49677, United States
Saint Mary's of Michigan
Saginaw, Michigan, 48601, United States
Providence Hospital
Southfield, Michigan, 48075, United States
Munson Medical Center
Traverse City, Michigan, 49684, United States
Saint John Macomb-Oakland Hospital
Warren, Michigan, 48093, United States
Sanford Clinic North-Bemidgi
Bemidji, Minnesota, 56601, United States
Essentia Health Saint Joseph's Medical Center
Brainerd, Minnesota, 56401, United States
Essentia Health Duluth Clinic CCOP
Duluth, Minnesota, 55805, United States
Essentia Health Saint Mary's Medical Center
Duluth, Minnesota, 55805, United States
Miller-Dwan Hospital
Duluth, Minnesota, 55805, United States
Lake Region Healthcare Corporation-Cancer Care
Fergus Falls, Minnesota, 56537, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216, United States
Saint Francis Medical Center
Cape Girardeau, Missouri, 63703, United States
Saint Louis Cancer and Breast Institute-South City
St Louis, Missouri, 63109, United States
Saint Louis University Hospital
St Louis, Missouri, 63110, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Saint John's Mercy Medical Center
St Louis, Missouri, 63141, United States
Saint Louis-Cape Girardeau CCOP
St Louis, Missouri, 63141, United States
Montana Cancer Consortium CCOP
Billings, Montana, 59101, United States
Saint Vincent Healthcare
Billings, Montana, 59101, United States
Hematology-Oncology Centers of the Northern Rockies PC
Billings, Montana, 59102, United States
Billings Clinic
Billings, Montana, 59107-7000, United States
Bozeman Deaconess Cancer Center
Bozeman, Montana, 59715, United States
Bozeman Deaconess Hospital
Bozeman, Montana, 59715, United States
Saint James Community Hospital and Cancer Treatment Center
Butte, Montana, 59701, United States
Benefis Healthcare- Sletten Cancer Institute
Great Falls, Montana, 59405, United States
Great Falls Clinic
Great Falls, Montana, 59405, United States
Northern Montana Hospital
Havre, Montana, 59501, United States
Saint Peter's Community Hospital
Helena, Montana, 59601, United States
Glacier Oncology PLLC
Kalispell, Montana, 59901, United States
Kalispell Medical Oncology
Kalispell, Montana, 59901, United States
Kalispell Regional Medical Center
Kalispell, Montana, 59901, United States
Montana Cancer Specialists
Missoula, Montana, 59802, United States
Saint Patrick Hospital - Community Hospital
Missoula, Montana, 59802, United States
Nevada Cancer Research Foundation CCOP
Las Vegas, Nevada, 89106, United States
Cooper Hospital University Medical Center
Camden, New Jersey, 08103, United States
Winthrop University Hospital
Mineola, New York, 11501, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
University of Rochester
Rochester, New York, 14642, United States
Park Ridge Hospital Breast Health Center
Hendersonville, North Carolina, 28792, United States
Kinston Medical Specialists PA
Kinston, North Carolina, 28501, United States
Roger Maris Cancer Center
Fargo, North Dakota, 58122, United States
Sanford Clinic North-Fargo
Fargo, North Dakota, 58122, United States
Sanford Medical Center-Fargo
Fargo, North Dakota, 58122, United States
Summa Akron City Hospital
Akron, Ohio, 44304, United States
Akron General Medical Center
Akron, Ohio, 44307, United States
Summa Barberton Hospital
Barberton, Ohio, 44203, United States
Aultman Health Foundation
Canton, Ohio, 44710, United States
The Jewish Hospital
Cincinnati, Ohio, 45236, United States
Case Western Reserve University
Cleveland, Ohio, 44106, United States
Grandview Hospital
Dayton, Ohio, 45405, United States
Good Samaritan Hospital - Dayton
Dayton, Ohio, 45406, United States
Miami Valley Hospital
Dayton, Ohio, 45409, United States
Samaritan North Health Center
Dayton, Ohio, 45415, United States
Dayton CCOP
Dayton, Ohio, 45420, United States
Blanchard Valley Hospital
Findlay, Ohio, 45840, United States
Atrium Medical Center-Middletown Regional Hospital
Franklin, Ohio, 45005-1066, United States
Wayne Hospital
Greenville, Ohio, 45331, United States
Kettering Medical Center
Kettering, Ohio, 45429, United States
Saint Rita's Medical Center
Lima, Ohio, 45801, United States
Upper Valley Medical Center
Troy, Ohio, 45373, United States
Clinton Memorial Hospital
Wilmington, Ohio, 45177, United States
Greene Memorial Hospital
Xenia, Ohio, 45385, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104, United States
Clackamas Radiation Oncology Center
Clackamas, Oregon, 97015, United States
Providence Milwaukie Hospital
Milwaukie, Oregon, 97222, United States
Providence Newberg Medical Center
Newberg, Oregon, 97132, United States
Providence Willamette Falls Medical Center
Oregon City, Oregon, 97045, United States
Providence Portland Medical Center
Portland, Oregon, 97213, United States
Columbia River Oncology Program
Portland, Oregon, 97225, United States
Providence Saint Vincent Medical Center
Portland, Oregon, 97225, United States
Lehigh Valley Hospital
Allentown, Pennsylvania, 18105, United States
Lehigh Valley Hospital - Muhlenberg
Bethlehem, Pennsylvania, 18017, United States
Geisinger Medical Center
Danville, Pennsylvania, 17822-2001, United States
Geisinger Medical Center-Cancer Center Hazelton
Hazleton, Pennsylvania, 18201, United States
Penn State Milton S Hershey Medical Center
Hershey, Pennsylvania, 17033-0850, United States
Lewistown Hospital
Lewistown, Pennsylvania, 17044, United States
Abramson Cancer Center of The University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111-2497, United States
Geisinger Medical Group
State College, Pennsylvania, 16801, United States
Mount Nittany Medical Center
State College, Pennsylvania, 16803, United States
Geisinger Wyoming Valley
Wilkes-Barre, Pennsylvania, 18711, United States
York Hospital
York, Pennsylvania, 17405, United States
AnMed Health Cancer Center
Anderson, South Carolina, 29621, United States
Saint Francis Hospital
Greenville, South Carolina, 29601, United States
Carolina Blood and Cancer Care Associates PA-Lancaster
Lancaster, South Carolina, 29720, United States
Carolina Blood and Cancer Care Associates PA
Rock Hill, South Carolina, 29732, United States
Spartanburg Regional Medical Center
Spartanburg, South Carolina, 29303, United States
Upstate Carolina CCOP
Spartanburg, South Carolina, 29303, United States
Sanford Cancer Center-Oncology Clinic
Sioux Falls, South Dakota, 57104, United States
Medical X-Ray Center
Sioux Falls, South Dakota, 57105, United States
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota, 57117-5134, United States
Erlanger Medical Center
Chattanooga, Tennessee, 37403, United States
Jackson-Madison County General Hospital
Jackson, Tennessee, 38301, United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232, United States
PeaceHealth Southwest Medical Center
Vancouver, Washington, 98664, United States
Northwest Cancer Specialists
Vancouver, Washington, 98684, United States
West Virginia University Charleston
Charleston, West Virginia, 25304, United States
West Virginia University
Morgantown, West Virginia, 26506, United States
Green Bay Oncology at Saint Vincent Hospital
Green Bay, Wisconsin, 54301-3526, United States
Saint Vincent Hospital
Green Bay, Wisconsin, 54301, United States
Green Bay Oncology Limited at Saint Mary's Hospital
Green Bay, Wisconsin, 54303, United States
Saint Mary's Hospital
Green Bay, Wisconsin, 54303, United States
Gundersen Lutheran
La Crosse, Wisconsin, 54601, United States
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, 53792, United States
Holy Family Memorial Hospital
Manitowoc, Wisconsin, 54221, United States
Bay Area Medical Center
Marinette, Wisconsin, 54143, United States
Froedtert and the Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
D N Greenwald Center
Mukwonago, Wisconsin, 53149, United States
Oconomowoc Memorial Hospital-ProHealth Care Inc
Oconomowoc, Wisconsin, 53066-3896, United States
Saint Nicholas Hospital
Sheboygan, Wisconsin, 53081, United States
Waukesha Memorial Hospital - ProHealth Care
Waukesha, Wisconsin, 53188, United States
Aurora Cancer Care-Milwaukee West
Wauwatosa, Wisconsin, 53226, United States
Rocky Mountain Oncology
Casper, Wyoming, 82609, United States
Welch Cancer Center
Sheridan, Wyoming, 82801, United States
Mayo Clinic Methodist Hospital
Nagpur, 440 018, India
Rambam Medical Center
Haifa, 31096, Israel
Shaare Zedek Medical Center
Jerusalem, 91031, Israel
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Statistician
- Organization
- ECOG-ACRIN Statistical Office
Study Officials
- PRINCIPAL INVESTIGATOR
James Foran
Eastern Cooperative Oncology Group
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 11, 2014
First Posted
March 12, 2014
Study Start
February 4, 2011
Primary Completion
February 22, 2021
Study Completion
December 21, 2022
Last Updated
December 13, 2024
Results First Posted
March 9, 2023
Record last verified: 2024-11
Data Sharing
- IPD Sharing
- Will share
Individual participant data may be made available upon request as per the ECOG-ACRIN Data Sharing Policy.