A Phase 3 Study of Active Surveillance for Low Risk and a Randomized Trial of Carboplatin vs. Cisplatin for Standard Risk Pediatric and Adult Patients With Germ Cell Tumors

Who is this study for? Patients with Tumor, Teratoma
Status: Recruiting
Location: See all (576) locations...
Intervention Type: Other, Procedure, Biological, Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

This phase III trial studies how well active surveillance help doctors to monitor subjects with low risk germ cell tumors for recurrence after their tumor is removed. When the germ cell tumors has spread outside of the organ in which it developed, it is considered metastatic. Drugs used in chemotherapy, such as bleomycin, carboplatin, etoposide, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. The trial studies whether carboplatin or cisplatin is the preferred chemotherapy to use in treating metastatic standard risk germ cell tumors.

Eligibility
Participation Requirements
Sex: All
Healthy Volunteers: No
View:

• There is no age limit for the low risk stratum (stage I ovarian immature teratoma and stage I non-seminoma or seminoma malignant GCT [all sites])

• Standard risk 1: Patient must be < 11 years of age at enrollment

• Standard risk 2: Patients must be >= 11 and < 25 years of age at enrollment

• Patients enrolling on one of the low risk arms must be newly diagnosed with a stage I germ cell tumor; for the standard risk arms, patients must be newly diagnosed with metastatic germ cell tumor (stage II or higher); histologic confirmation of a primary extracranial germ cell tumor in any of the categories outlined below is required of all patients at enrollment except for those who were initially diagnosed with stage I non-seminoma malignant GCT and later recur during observation post surgery off study; for these patients, if elevated tumor markers rise to > 5 x upper limit of normal (ULN) on at least 2 measurements taken at least 1 week apart, a diagnostic biopsy is not required for enrollment

• Low risk stage I immature teratoma (IT); site: ovarian; stage: Children's Oncology Group (COG) stage I, Federation of Gynecology and Obstetrics (FIGO) stage IA and IB; grade: 2 or 3; histology: pure immature teratoma (may contain microscopic foci of yolk sac tumor), mixed immature and mature teratoma, (no pathological evidence of MGCT); tumor markers: alpha-FP =< 1,000 ng/mL, beta-HCG institutional normal; all ages

• Low risk stage I non-seminoma MGCT; site: ovarian, testicular, or extragonadal; stage: COG stage I, FIGO stage IA and IB, American Joint Committee on Cancer (AJCC) testicular stage IA, IB and IS; histology: must contain at least one of the following: yolk sac tumor, embryonal carcinoma, or choriocarcinoma (pure or mixed); all ages

• Low risk stage I seminoma-MGCT; site: testicular; stage: COG stage I; AJCC testicular stage IA IB, and IS; histology: must contain at least one of the following: may contain immature/mature teratoma; may NOT contain yolk sac tumor, embryonal carcinoma, or choriocarcinoma; all ages

• Standard risk 1 (SR1); site: ovarian, testicular, or extragonadal; stage: COG stage II-IV, FIGO stage IC, FIGO stage II-IV (International Germ Cell Consensus Classification [IGCCC] criteria DO NOT apply); histology: must contain at least one of the following: yolk sac tumor, embryonal carcinoma, or choriocarcinoma; age (years) < 11

• Standard risk 2 (SR2)

• Site: ovarian; stage: COG stage II and III, FIGO stage IC, II and III; histology: must contain at least one of the following: yolk sac tumor, embryonal carcinoma, or choriocarcinoma; age (years) >= 11 and < 25

• Site: testicular; stage: COG stage II-IV, AJCC stage II, III, IGCCC good risk; histology: must contain at least one of the following: yolk sac tumor, embryonal carcinoma, or choriocarcinoma; tumor markers: must be IGCCC good risk; post op: alpha-FP < 1,000 ng/mL, beta-HCG < 5,000 IU/mL and lactate dehydrogenase (LDH) < 3.0 x normal; age (years) >= 11 and < 25

• Site: extragonadal; stage: COG stage II; histology: must contain at least one of the following: yolk sac tumor, embryonal carcinoma, or choriocarcinoma; age (years) >= 11 and < 25

• Notes:

• IGCCC criteria only apply to SR2 patients with a testicular primary tumor

• Use post-op tumor marker levels to determine IGCCC risk group

• Stage 1 seminoma patients are not eligible for the standard risk arms of the study

• For the low risk stage I non-seminoma MGCT and the standard risk arms, components of yolk sac tumor, embryonal carcinoma, or choriocarcinoma can be mixed with other forms of GCT, such as seminoma or mature or immature teratoma; if yolk sac tumor is the only malignant component present, then it must be deemed by the pathologist to be greater than a microscopic component of yolk sac tumor

• Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1, 2 or 3; use Karnofsky for patients > 16 years of age and Lansky for patients =< 16 years of age

• Organ function requirements apply ONLY to patients who will receive chemotherapy (SR1 and SR2 patients)

• Adequate renal function defined as:

• Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 mL/min/1.73 m^2 (within 7 days prior to enrollment) OR

• A serum creatinine based on age/gender as follows (within 7 days prior to enrollment): (mg/dL)

• 1 month to < 6 months male: 0.4 female: 0.4

• 6 months to < 1 year male: 0.5 female: 0.5

• 1 to < 2 years male: 0.6 female: 0.6

• >= 16 years male: 1.7 female: 1.4

• Total bilirubin =< 1.5 x upper limit of normal (ULN) for age (within 7 days prior to enrollment)

• Serum glutamic-oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) or serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) < 2.5 x upper limit of normal (ULN) for age (for the purpose of this study, the ULN for SGPT is 45 U/L) (within 7 days prior to enrollment)

• Peripheral absolute neutrophil count (ANC) >= 1,000/mm^3 (within 7 days prior to enrollment) AND

• Platelet count >= 100,000/mm^3 (within 7 days prior to enrollment)

• Patients enrolling on the standard risk arms must be medically fit to receive protocol treatment and with no contraindications to protocol treatment

• Eligibility criteria to participate in the pilot study of the AYA-Hears instrument (patient reported outcomes [PROs] of ototoxicity) Note: participants in group 1 will not receive AGCT1531 protocol-directed therapy; all other AYA-HEARS patients must be enrolled on the AGCT1531 SR2 arm in order to participate

• >= 11 and < 25 years old at enrollment

• Able to fluently speak and read English

• Has received prior cisplatin- or carboplatin-based chemotherapy regimen for malignancy including diagnoses other than germ cell tumor

• Followed for cancer or survivorship care at one of the following institutions:

• Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center

• Dana Farber/Harvard Cancer Center

• Hospital for Sick Children

• Children's Hospital of Eastern Ontario

• Oregon Health and Science University

• Seattle Children's Hospital

• Yale University

Locations
United States
Alaska
Alaska Breast Care and Surgery LLC
Suspended
Anchorage
Alaska Oncology and Hematology LLC
Suspended
Anchorage
Alaska Women's Cancer Care
Suspended
Anchorage
Anchorage Associates in Radiation Medicine
Suspended
Anchorage
Anchorage Oncology Centre
Suspended
Anchorage
Anchorage Radiation Therapy Center
Suspended
Anchorage
Katmai Oncology Group
Suspended
Anchorage
Providence Alaska Medical Center
Suspended
Anchorage
Alabama
Children's Hospital of Alabama
Recruiting
Birmingham
USA Health Strada Patient Care Center
Suspended
Mobile
Arkansas
CHI Saint Vincent Cancer Center Hot Springs
Suspended
Hot Springs
Arkansas Children's Hospital
Suspended
Little Rock
University of Arkansas for Medical Sciences
Active, not recruiting
Little Rock
Arizona
Kingman Regional Medical Center
Suspended
Kingman
Banner Children's at Desert
Suspended
Mesa
Cancer Center at Saint Joseph's
Suspended
Phoenix
Phoenix Childrens Hospital
Suspended
Phoenix
Banner University Medical Center - Tucson
Active, not recruiting
Tucson
University of Arizona Cancer Center-North Campus
Active, not recruiting
Tucson
California
Kaiser Permanente-Anaheim
Suspended
Anaheim
Mission Hope Medical Oncology - Arroyo Grande
Suspended
Arroyo Grande
PCR Oncology
Suspended
Arroyo Grande
Kaiser Permanente-Bellflower
Suspended
Bellflower
Providence Saint Joseph Medical Center/Disney Family Cancer Center
Suspended
Burbank
Kaiser Permanente Downey Medical Center
Suspended
Downey
City of Hope Comprehensive Cancer Center
Active, not recruiting
Duarte
Kaiser Permanente-Fontana
Suspended
Fontana
Loma Linda University Medical Center
Recruiting
Loma Linda
Miller Children's and Women's Hospital Long Beach
Suspended
Long Beach
Cedars Sinai Medical Center
Suspended
Los Angeles
Children's Hospital Los Angeles
Suspended
Los Angeles
Kaiser Permanente Los Angeles Medical Center
Suspended
Los Angeles
Los Angeles County-USC Medical Center
Active, not recruiting
Los Angeles
Mattel Children's Hospital UCLA
Suspended
Los Angeles
UCLA / Jonsson Comprehensive Cancer Center
Suspended
Los Angeles
USC / Norris Comprehensive Cancer Center
Active, not recruiting
Los Angeles
Valley Children's Hospital
Suspended
Madera
Providence Queen of The Valley
Suspended
Napa
USC Norris Oncology/Hematology-Newport Beach
Active, not recruiting
Newport Beach
Kaiser Permanente-Oakland
Suspended
Oakland
UCSF Benioff Children's Hospital Oakland
Suspended
Oakland
Children's Hospital of Orange County
Suspended
Orange
Lucile Packard Children's Hospital Stanford University
Suspended
Palo Alto
Stanford Cancer Institute Palo Alto
Suspended
Palo Alto
Kaiser Permanente-Roseville
Active, not recruiting
Roseville
Sutter Medical Center Sacramento
Active, not recruiting
Sacramento
University of California Davis Comprehensive Cancer Center
Suspended
Sacramento
Kaiser Permanente-San Diego Mission
Suspended
San Diego
Naval Medical Center -San Diego
Suspended
San Diego
Rady Children's Hospital - San Diego
Suspended
San Diego
UCSF Medical Center-Mission Bay
Suspended
San Francisco
Pacific Central Coast Health Center-San Luis Obispo
Suspended
San Luis Obispo
Kaiser Permanente Medical Center - Santa Clara
Active, not recruiting
Santa Clara
Mission Hope Medical Oncology - Santa Maria
Suspended
Santa Maria
Providence Medical Foundation - Santa Rosa
Suspended
Santa Rosa
Providence Santa Rosa Memorial Hospital
Suspended
Santa Rosa
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Suspended
Torrance
Colorado
Children's Hospital Colorado
Suspended
Aurora
University of Colorado Hospital
Active, not recruiting
Aurora
Memorial Hospital North
Active, not recruiting
Colorado Springs
Penrose-Saint Francis Healthcare
Suspended
Colorado Springs
Rocky Mountain Cancer Centers-Penrose
Suspended
Colorado Springs
Saint Francis Cancer Center
Suspended
Colorado Springs
UCHealth Memorial Hospital Central
Active, not recruiting
Colorado Springs
Porter Adventist Hospital
Suspended
Denver
Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center
Suspended
Denver
Mercy Medical Center
Suspended
Durango
Southwest Oncology PC
Suspended
Durango
Cancer Care and Hematology-Fort Collins
Active, not recruiting
Fort Collins
Poudre Valley Hospital
Active, not recruiting
Fort Collins
Mountain Blue Cancer Care Center
Suspended
Golden
UCHealth Greeley Hospital
Active, not recruiting
Greeley
Rocky Mountain Cancer Centers-Lakewood
Suspended
Lakewood
Saint Anthony Hospital
Suspended
Lakewood
Littleton Adventist Hospital
Suspended
Littleton
UCHealth Lone Tree Health Center
Active, not recruiting
Lone Tree
Longmont United Hospital
Suspended
Longmont
Rocky Mountain Cancer Centers-Longmont
Suspended
Longmont
Medical Center of the Rockies
Active, not recruiting
Loveland
Parker Adventist Hospital
Suspended
Parker
Rocky Mountain Cancer Centers-Parker
Suspended
Parker
Rocky Mountain Cancer Centers - Pueblo
Suspended
Pueblo
Saint Mary Corwin Medical Center
Suspended
Pueblo
Rocky Mountain Cancer Centers-Thornton
Suspended
Thornton
Connecticut
Connecticut Children's Medical Center
Suspended
Hartford
Yale University
Suspended
New Haven
Washington, D.c.
Children's National Medical Center
Suspended
Washington
Kaiser Permanente-Capitol Hill Medical Center
Suspended
Washington
MedStar Georgetown University Hospital
Suspended
Washington
Delaware
Alfred I duPont Hospital for Children
Suspended
Wilmington
Florida
Broward Health Medical Center
Suspended
Fort Lauderdale
Golisano Children's Hospital of Southwest Florida
Recruiting
Fort Myers
University of Florida Health Science Center - Gainesville
Suspended
Gainesville
Memorial Regional Hospital/Joe DiMaggio Children's Hospital
Suspended
Hollywood
Nemours Children's Clinic-Jacksonville
Suspended
Jacksonville
Miami Cancer Institute
Suspended
Miami
Nicklaus Children's Hospital
Suspended
Miami
University of Miami Miller School of Medicine-Sylvester Cancer Center
Suspended
Miami
AdventHealth Orlando
Suspended
Orlando
Arnold Palmer Hospital for Children
Suspended
Orlando
Nemours Children's Hospital
Suspended
Orlando
Nemours Children's Clinic - Pensacola
Active, not recruiting
Pensacola
Sacred Heart Hospital
Suspended
Pensacola
Johns Hopkins All Children's Hospital
Suspended
Saint Petersburg
Saint Joseph's Hospital/Children's Hospital-Tampa
Suspended
Tampa
Tampa General Hospital
Suspended
Tampa
Saint Mary's Hospital
Suspended
West Palm Beach
Georgia
Children's Healthcare of Atlanta - Egleston
Suspended
Atlanta
Augusta University Medical Center
Suspended
Augusta
Medical Center of Central Georgia
Suspended
Macon
Memorial Health University Medical Center
Suspended
Savannah
Hawaii
Kaiser Permanente Moanalua Medical Center
Suspended
Honolulu
Kapiolani Medical Center for Women and Children
Suspended
Honolulu
Straub Clinic and Hospital
Suspended
Honolulu
Tripler Army Medical Center
Recruiting
Honolulu
Iowa
Medical Oncology and Hematology Associates-West Des Moines
Recruiting
Clive
Mercy Cancer Center-West Lakes
Recruiting
Clive
Alegent Health Mercy Hospital
Suspended
Council Bluffs
Greater Regional Medical Center
Recruiting
Creston
Blank Children's Hospital
Suspended
Des Moines
Iowa Lutheran Hospital
Suspended
Des Moines
Iowa Methodist Medical Center
Suspended
Des Moines
Mercy Medical Center - Des Moines
Recruiting
Des Moines
Mission Cancer and Blood - Laurel
Recruiting
Des Moines
University of Iowa/Holden Comprehensive Cancer Center
Recruiting
Iowa City
Mercy Medical Center-West Lakes
Recruiting
West Des Moines
Idaho
Saint Luke's Cancer Institute - Boise
Suspended
Boise
Saint Luke's Cancer Institute - Fruitland
Suspended
Fruitland
Saint Luke's Cancer Institute - Meridian
Suspended
Meridian
Saint Luke's Cancer Institute - Nampa
Suspended
Nampa
Saint Luke's Cancer Institute - Twin Falls
Suspended
Twin Falls
Illinois
Rush - Copley Medical Center
Active, not recruiting
Aurora
Illinois CancerCare-Bloomington
Suspended
Bloomington
Illinois CancerCare-Canton
Suspended
Canton
Memorial Hospital of Carbondale
Suspended
Carbondale
SIH Cancer Institute
Suspended
Carterville
Illinois CancerCare-Carthage
Suspended
Carthage
Centralia Oncology Clinic
Suspended
Centralia
John H Stroger Jr Hospital of Cook County
Suspended
Chicago
Lurie Children's Hospital-Chicago
Recruiting
Chicago
Rush University Medical Center
Suspended
Chicago
University of Chicago Comprehensive Cancer Center
Suspended
Chicago
University of Illinois
Suspended
Chicago
Carle on Vermilion
Active, not recruiting
Danville
Cancer Care Specialists of Illinois - Decatur
Suspended
Decatur
Decatur Memorial Hospital
Suspended
Decatur
Illinois CancerCare-Dixon
Suspended
Dixon
Carle Physician Group-Effingham
Active, not recruiting
Effingham
Crossroads Cancer Center
Suspended
Effingham
Illinois CancerCare-Eureka
Suspended
Eureka
NorthShore University HealthSystem-Evanston Hospital
Suspended
Evanston
Illinois CancerCare-Galesburg
Suspended
Galesburg
Western Illinois Cancer Treatment Center
Suspended
Galesburg
NorthShore University HealthSystem-Glenbrook Hospital
Suspended
Glenview
NorthShore University HealthSystem-Highland Park Hospital
Suspended
Highland Park
Illinois CancerCare-Kewanee Clinic
Suspended
Kewanee
Illinois CancerCare-Macomb
Suspended
Macomb
Carle Physician Group-Mattoon/Charleston
Active, not recruiting
Mattoon
Loyola University Medical Center
Active, not recruiting
Maywood
Cancer Care Center of O'Fallon
Suspended
O'fallon
Advocate Children's Hospital-Oak Lawn
Suspended
Oak Lawn
Illinois CancerCare-Ottawa Clinic
Suspended
Ottawa
Advocate Children's Hospital-Park Ridge
Suspended
Park Ridge
Illinois CancerCare-Pekin
Suspended
Pekin
OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center
Suspended
Pekin
Illinois CancerCare-Peoria
Suspended
Peoria
Methodist Medical Center of Illinois
Suspended
Peoria
OSF Saint Francis Medical Center
Suspended
Peoria
OSF Saint Francis Radiation Oncology at Peoria Cancer Center
Suspended
Peoria
Saint Jude Midwest Affiliate
Suspended
Peoria
Illinois CancerCare-Peru
Suspended
Peru
Valley Radiation Oncology
Suspended
Peru
Illinois CancerCare-Princeton
Suspended
Princeton
North Shore Medical Center
Suspended
Skokie
Memorial Medical Center
Suspended
Springfield
Saint John's Hospital
Suspended
Springfield
Southern Illinois University School of Medicine
Suspended
Springfield
Springfield Clinic
Suspended
Springfield
Southwest Illinois Health Services LLP
Suspended
Swansea
Carle Cancer Center
Active, not recruiting
Urbana
The Carle Foundation Hospital
Active, not recruiting
Urbana
Illinois CancerCare - Washington
Suspended
Washington
Rush-Copley Healthcare Center
Active, not recruiting
Yorkville
Indiana
IU Health North Hospital
Suspended
Carmel
Deaconess Clinic Downtown
Active, not recruiting
Evansville
Ascension Saint Vincent Indianapolis Hospital
Suspended
Indianapolis
Indiana University/Melvin and Bren Simon Cancer Center
Active, not recruiting
Indianapolis
Riley Hospital for Children
Recruiting
Indianapolis
Chancellor Center for Oncology
Active, not recruiting
Newburgh
Memorial Hospital of South Bend
Suspended
South Bend
Kentucky
Flaget Memorial Hospital
Suspended
Bardstown
Commonwealth Cancer Center-Corbin
Suspended
Corbin
Saint Joseph Hospital East
Suspended
Lexington
Saint Joseph Radiation Oncology Resource Center
Suspended
Lexington
University of Kentucky/Markey Cancer Center
Suspended
Lexington
Saint Joseph London
Suspended
London
Jewish Hospital
Suspended
Louisville
Norton Children's Hospital
Suspended
Louisville
Saints Mary and Elizabeth Hospital
Suspended
Louisville
UofL Health Medical Center Northeast
Suspended
Louisville
Jewish Hospital Medical Center South
Suspended
Shepherdsville
Louisiana
Children's Hospital New Orleans
Suspended
New Orleans
Ochsner Medical Center Jefferson
Active, not recruiting
New Orleans
Massachusetts
Dana-Farber Cancer Institute
Suspended
Boston
Massachusetts General Hospital Cancer Center
Suspended
Boston
Tufts Children's Hospital
Suspended
Boston
Tufts Medical Center
Suspended
Boston
UMass Memorial Medical Center - University Campus
Suspended
Worcester
Maryland
Johns Hopkins University/Sidney Kimmel Cancer Center
Suspended
Baltimore
Sinai Hospital of Baltimore
Suspended
Baltimore
University of Maryland/Greenebaum Cancer Center
Suspended
Baltimore
Walter Reed National Military Medical Center
Suspended
Bethesda
Maine
Eastern Maine Medical Center
Suspended
Bangor
Lafayette Family Cancer Center-EMMC
Active, not recruiting
Brewer
Maine Medical Center-Bramhall Campus
Suspended
Portland
Maine Children's Cancer Program
Suspended
Scarborough
Maine Medical Center- Scarborough Campus
Suspended
Scarborough
Michigan
C S Mott Children's Hospital
Suspended
Ann Arbor
Bronson Battle Creek
Suspended
Battle Creek
Ascension Saint John Hospital
Suspended
Detroit
Children's Hospital of Michigan
Suspended
Detroit
Michigan State University Clinical Center
Suspended
East Lansing
Green Bay Oncology - Escanaba
Active, not recruiting
Escanaba
Hurley Medical Center
Active, not recruiting
Flint
Helen DeVos Children's Hospital at Spectrum Health
Suspended
Grand Rapids
Mercy Health Saint Mary's
Suspended
Grand Rapids
Spectrum Health at Butterworth Campus
Suspended
Grand Rapids
Borgess Medical Center
Suspended
Kalamazoo
Bronson Methodist Hospital
Suspended
Kalamazoo
West Michigan Cancer Center
Suspended
Kalamazoo
Mercy Health Mercy Campus
Suspended
Muskegon
Lakeland Hospital Niles
Suspended
Niles
Lake Huron Medical Center
Suspended
Port Huron
Spectrum Health Reed City Hospital
Suspended
Reed City
Beaumont Children's Hospital-Royal Oak
Suspended
Royal Oak
Lakeland Medical Center Saint Joseph
Suspended
Saint Joseph
Marie Yeager Cancer Center
Suspended
Saint Joseph
Munson Medical Center
Suspended
Traverse City
Metro Health Hospital
Suspended
Wyoming
Minnesota
Essentia Health Cancer Center
Active, not recruiting
Duluth
Children's Hospitals and Clinics of Minnesota - Minneapolis
Suspended
Minneapolis
University of Minnesota/Masonic Cancer Center
Suspended
Minneapolis
Mayo Clinic in Rochester
Suspended
Rochester
Missouri
Parkland Health Center-Bonne Terre
Suspended
Bonne Terre
Saint Francis Medical Center
Suspended
Cape Girardeau
Southeast Cancer Center
Suspended
Cape Girardeau
Parkland Health Center - Farmington
Suspended
Farmington
Capital Region Southwest Campus
Suspended
Jefferson City
Children's Mercy Hospitals and Clinics
Suspended
Kansas City
Mercy Hospital Saint Louis
Suspended
Saint Louis
Missouri Baptist Medical Center
Suspended
Saint Louis
Washington University School of Medicine
Suspended
Saint Louis
Sainte Genevieve County Memorial Hospital
Suspended
Sainte Genevieve
Missouri Baptist Sullivan Hospital
Suspended
Sullivan
Missouri Baptist Outpatient Center-Sunset Hills
Suspended
Sunset Hills
Mississippi
University of Mississippi Medical Center
Suspended
Jackson
Montana
Saint Patrick Hospital - Community Hospital
Suspended
Missoula
North Carolina
Mission Hospital
Suspended
Asheville
UNC Lineberger Comprehensive Cancer Center
Suspended
Chapel Hill
Carolinas Medical Center/Levine Cancer Institute
Suspended
Charlotte
Novant Health Presbyterian Medical Center
Suspended
Charlotte
Oncology Specialists of Charlotte
Suspended
Charlotte
Southern Oncology Specialists-Charlotte
Suspended
Charlotte
Southeastern Medical Oncology Center-Clinton
Suspended
Clinton
Duke University Medical Center
Recruiting
Durham
Southeastern Medical Oncology Center-Goldsboro
Suspended
Goldsboro
Wayne Memorial Hospital
Active, not recruiting
Goldsboro
Novant Health Cancer Institute - Huntersville
Suspended
Huntersville
Southern Oncology Specialists-Huntersville
Suspended
Huntersville
Southeastern Medical Oncology Center-Jacksonville
Suspended
Jacksonville
Matthews Radiation Oncology Center
Suspended
Matthews
Novant Health Cancer Institute - Matthews
Suspended
Matthews
Novant Health Cancer Institute - Mooresville
Suspended
Mooresville
Novant Health Cancer Institute - Rowan
Suspended
Salisbury
Rowan Regional Medical Center
Suspended
Salisbury
Wake Forest University Health Sciences
Suspended
Winston-salem
North Dakota
Sanford Broadway Medical Center
Recruiting
Fargo
Nebraska
CHI Health Saint Francis
Suspended
Grand Island
CHI Health Good Samaritan
Suspended
Kearney
Heartland Hematology and Oncology
Suspended
Kearney
Saint Elizabeth Regional Medical Center
Suspended
Lincoln
Alegent Health Bergan Mercy Medical Center
Suspended
Omaha
Alegent Health Immanuel Medical Center
Suspended
Omaha
Alegent Health Lakeside Hospital
Suspended
Omaha
Children's Hospital and Medical Center of Omaha
Suspended
Omaha
Creighton University Medical Center
Suspended
Omaha
Hematology and Oncology Consultants PC
Suspended
Omaha
University of Nebraska Medical Center
Suspended
Omaha
Midlands Community Hospital
Suspended
Papillion
New Hampshire
Dartmouth Hitchcock Medical Center
Suspended
Lebanon
New Jersey
Hackensack University Medical Center
Suspended
Hackensack
Morristown Medical Center
Suspended
Morristown
Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital
Suspended
New Brunswick
Newark Beth Israel Medical Center
Recruiting
Newark
Saint Joseph's Regional Medical Center
Suspended
Paterson
New Mexico
University of New Mexico Cancer Center
Suspended
Albuquerque
Nevada
Carson Tahoe Regional Medical Center
Suspended
Carson City
Cancer and Blood Specialists-Henderson
Suspended
Henderson
Comprehensive Cancer Centers of Nevada - Henderson
Suspended
Henderson
Comprehensive Cancer Centers of Nevada-Horizon Ridge
Suspended
Henderson
Comprehensive Cancer Centers of Nevada-Southeast Henderson
Suspended
Henderson
Las Vegas Cancer Center-Henderson
Suspended
Henderson
Las Vegas Urology - Green Valley
Suspended
Henderson
Las Vegas Urology - Pebble
Suspended
Henderson
OptumCare Cancer Care at Seven Hills
Suspended
Henderson
Urology Specialists of Nevada - Green Valley
Suspended
Henderson
Alliance for Childhood Diseases/Cure 4 the Kids Foundation
Suspended
Las Vegas
Ann M Wierman MD LTD
Suspended
Las Vegas
Cancer and Blood Specialists-Shadow
Suspended
Las Vegas
Cancer and Blood Specialists-Tenaya
Suspended
Las Vegas
Cancer Therapy and Integrative Medicine
Suspended
Las Vegas
Comprehensive Cancer Centers of Nevada
Suspended
Las Vegas
Comprehensive Cancer Centers of Nevada - Central Valley
Suspended
Las Vegas
Comprehensive Cancer Centers of Nevada - Northwest
Suspended
Las Vegas
Comprehensive Cancer Centers of Nevada - Town Center
Suspended
Las Vegas
Comprehensive Cancer Centers of Nevada-Summerlin
Suspended
Las Vegas
Desert West Surgery
Suspended
Las Vegas
Hope Cancer Care of Nevada
Suspended
Las Vegas
Las Vegas Cancer Center-Medical Center
Suspended
Las Vegas
Las Vegas Urology - Cathedral Rock
Suspended
Las Vegas
Las Vegas Urology - Pecos
Suspended
Las Vegas
Las Vegas Urology - Smoke Ranch
Suspended
Las Vegas
Las Vegas Urology - Sunset
Suspended
Las Vegas
OptumCare Cancer Care at Charleston
Suspended
Las Vegas
OptumCare Cancer Care at Fort Apache
Suspended
Las Vegas
OptumCare Cancer Care at MountainView
Suspended
Las Vegas
Radiation Oncology Centers of Nevada Central
Suspended
Las Vegas
Radiation Oncology Centers of Nevada Southeast
Suspended
Las Vegas
Summerlin Hospital Medical Center
Suspended
Las Vegas
Sunrise Hospital and Medical Center
Suspended
Las Vegas
University Cancer Center
Suspended
Las Vegas
University Medical Center of Southern Nevada
Suspended
Las Vegas
Urology Specialists of Nevada - Central
Suspended
Las Vegas
Urology Specialists of Nevada - Northwest
Suspended
Las Vegas
Urology Specialists of Nevada - Southwest
Suspended
Las Vegas
Women's Cancer Center of Nevada
Recruiting
Las Vegas
Hope Cancer Care of Nevada-Pahrump
Suspended
Pahrump
Cancer Care Specialists - Reno
Suspended
Reno
Radiation Oncology Associates
Suspended
Reno
Renown Regional Medical Center
Suspended
Reno
Saint Mary's Regional Medical Center
Suspended
Reno
New York
Albany Medical Center
Suspended
Albany
Montefiore Medical Center - Moses Campus
Suspended
Bronx
Maimonides Medical Center
Recruiting
Brooklyn
Roswell Park Cancer Institute
Suspended
Buffalo
Glens Falls Hospital
Active, not recruiting
Glens Falls
NYU Winthrop Hospital
Suspended
Mineola
The Steven and Alexandra Cohen Children's Medical Center of New York
Recruiting
New Hyde Park
Laura and Isaac Perlmutter Cancer Center at NYU Langone
Suspended
New York
Memorial Sloan Kettering Cancer Center
Recruiting
New York
Mount Sinai Hospital
Suspended
New York
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
Suspended
New York
University of Rochester
Suspended
Rochester
Stony Brook University Medical Center
Suspended
Stony Brook
State University of New York Upstate Medical University
Suspended
Syracuse
New York Medical College
Suspended
Valhalla
Westchester Medical Center
Suspended
Valhalla
Ohio
Children's Hospital Medical Center of Akron
Suspended
Akron
Strecker Cancer Center-Belpre
Suspended
Belpre
Adena Regional Medical Center
Suspended
Chillicothe
Bethesda North Hospital
Suspended
Cincinnati
Cincinnati Children's Hospital Medical Center
Suspended
Cincinnati
Good Samaritan Hospital - Cincinnati
Suspended
Cincinnati
TriHealth Cancer Institute-Anderson
Suspended
Cincinnati
TriHealth Cancer Institute-Westside
Suspended
Cincinnati
Case Western Reserve University
Suspended
Cleveland
Cleveland Clinic Foundation
Suspended
Cleveland
Rainbow Babies and Childrens Hospital
Suspended
Cleveland
Columbus Oncology and Hematology Associates Inc
Suspended
Columbus
Doctors Hospital
Suspended
Columbus
Grant Medical Center
Suspended
Columbus
Mount Carmel East Hospital
Suspended
Columbus
Mount Carmel Health Center West
Suspended
Columbus
Nationwide Children's Hospital
Suspended
Columbus
Riverside Methodist Hospital
Suspended
Columbus
The Mark H Zangmeister Center
Suspended
Columbus
Dayton Children's Hospital
Suspended
Dayton
Delaware Health Center-Grady Cancer Center
Suspended
Delaware
Grady Memorial Hospital
Suspended
Delaware
Columbus Oncology and Hematology Associates
Suspended
Dublin
Dublin Methodist Hospital
Suspended
Dublin
Mount Carmel Grove City Hospital
Suspended
Grove City
Saint Rita's Medical Center
Suspended
Lima
OhioHealth Mansfield Hospital
Suspended
Mansfield
Marietta Memorial Hospital
Suspended
Marietta
OhioHealth Marion General Hospital
Suspended
Marion
Knox Community Hospital
Suspended
Mount Vernon
Licking Memorial Hospital
Suspended
Newark
Mercy Health Perrysburg Cancer Center
Suspended
Perrysburg
Southern Ohio Medical Center
Suspended
Portsmouth
ProMedica Flower Hospital
Suspended
Sylvania
Mercy Health - Saint Anne Hospital
Suspended
Toledo
ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital
Suspended
Toledo
Saint Vincent Mercy Medical Center
Suspended
Toledo
Saint Ann's Hospital
Suspended
Westerville
Genesis Healthcare System Cancer Care Center
Suspended
Zanesville
Oklahoma
Cancer Centers of Southwest Oklahoma Research
Suspended
Lawton
University of Oklahoma Health Sciences Center
Suspended
Oklahoma City
Oregon
Saint Charles Health System
Suspended
Bend
Clackamas Radiation Oncology Center
Suspended
Clackamas
Providence Cancer Institute Clackamas Clinic
Suspended
Clackamas
Bay Area Hospital
Suspended
Coos Bay
Rogue Valley Medical Center
Suspended
Medford
Providence Newberg Medical Center
Suspended
Newberg
Legacy Emanuel Children's Hospital
Suspended
Portland
Oregon Health and Science University
Suspended
Portland
Providence Portland Medical Center
Suspended
Portland
Providence Saint Vincent Medical Center
Suspended
Portland
Pennsylvania
Jefferson Abington Hospital
Suspended
Abington
Lehigh Valley Hospital-Cedar Crest
Suspended
Allentown
Lehigh Valley Hospital - Muhlenberg
Suspended
Bethlehem
Geisinger Medical Center
Suspended
Danville
Penn State Children's Hospital
Suspended
Hershey
Children's Hospital of Philadelphia
Suspended
Philadelphia
Saint Christopher's Hospital for Children
Suspended
Philadelphia
Children's Hospital of Pittsburgh of UPMC
Suspended
Pittsburgh
University of Pittsburgh Cancer Institute (UPCI)
Suspended
Pittsburgh
UPMC-Magee Womens Hospital
Suspended
Pittsburgh
UPMC-Passavant Hospital
Suspended
Pittsburgh
Asplundh Cancer Pavilion
Suspended
Willow Grove
Rhode Island
Rhode Island Hospital
Suspended
Providence
South Carolina
Prisma Health Cancer Institute - Spartanburg
Suspended
Boiling Springs
Medical University of South Carolina
Suspended
Charleston
Prisma Health Richland Hospital
Suspended
Columbia
Gibbs Cancer Center-Gaffney
Suspended
Gaffney
BI-LO Charities Children's Cancer Center
Suspended
Greenville
Prisma Health Cancer Institute - Butternut
Suspended
Greenville
Prisma Health Cancer Institute - Eastside
Suspended
Greenville
Prisma Health Cancer Institute - Faris
Suspended
Greenville
Prisma Health Greenville Memorial Hospital
Suspended
Greenville
Saint Francis Cancer Center
Suspended
Greenville
Saint Francis Hospital
Suspended
Greenville
Gibbs Cancer Center-Pelham
Suspended
Greer
Prisma Health Cancer Institute - Greer
Suspended
Greer
Prisma Health Cancer Institute - Seneca
Suspended
Seneca
North Grove Medical Park
Suspended
Spartanburg
Spartanburg Medical Center
Suspended
Spartanburg
Spartanburg Medical Center - Mary Black Campus
Suspended
Spartanburg
MGC Hematology Oncology-Union
Suspended
Union
South Dakota
Sanford USD Medical Center - Sioux Falls
Suspended
Sioux Falls
Tennessee
Memorial Hospital
Suspended
Chattanooga
T C Thompson Children's Hospital
Suspended
Chattanooga
Pulmonary Medicine Center of Chattanooga-Hixson
Suspended
Hixson
East Tennessee Childrens Hospital
Suspended
Knoxville
Saint Jude Children's Research Hospital
Suspended
Memphis
The Children's Hospital at TriStar Centennial
Suspended
Nashville
Vanderbilt University/Ingram Cancer Center
Suspended
Nashville
Memorial GYN Plus
Suspended
Ooltewah
Texas
The Don and Sybil Harrington Cancer Center
Suspended
Amarillo
Dell Children's Medical Center of Central Texas
Suspended
Austin
Saint Joseph Regional Cancer Center
Suspended
Bryan
Driscoll Children's Hospital
Suspended
Corpus Christi
Medical City Dallas Hospital
Suspended
Dallas
Parkland Memorial Hospital
Suspended
Dallas
UT Southwestern/Simmons Cancer Center-Dallas
Suspended
Dallas
El Paso Children's Hospital
Suspended
El Paso
Texas Tech University Health Sciences Center-El Paso
Suspended
El Paso
Cook Children's Medical Center
Suspended
Fort Worth
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Suspended
Houston
M D Anderson Cancer Center
Suspended
Houston
Covenant Children's Hospital
Suspended
Lubbock
Texas Tech University Health Sciences Center-Lubbock
Active, not recruiting
Lubbock
UMC Cancer Center / UMC Health System
Suspended
Lubbock
Children's Hospital of San Antonio
Suspended
San Antonio
Methodist Children's Hospital of South Texas
Suspended
San Antonio
University Hospital
Suspended
San Antonio
University of Texas Health Science Center at San Antonio
Suspended
San Antonio
Scott and White Memorial Hospital
Suspended
Temple
Utah
Primary Children's Hospital
Recruiting
Salt Lake City
Virginia
Children's Hospital of The King's Daughters
Suspended
Norfolk
Naval Medical Center - Portsmouth
Suspended
Portsmouth
Virginia Commonwealth University/Massey Cancer Center
Suspended
Richmond
Vermont
Central Vermont Medical Center/National Life Cancer Treatment
Active, not recruiting
Berlin
University of Vermont and State Agricultural College
Suspended
Burlington
University of Vermont Medical Center
Active, not recruiting
Burlington
Washington
Providence Regional Cancer System-Aberdeen
Suspended
Aberdeen
Overlake Medical Center
Suspended
Bellevue
PeaceHealth Saint Joseph Medical Center
Suspended
Bellingham
Harrison HealthPartners Hematology and Oncology-Bremerton
Recruiting
Bremerton
Harrison Medical Center
Suspended
Bremerton
Highline Medical Center-Main Campus
Suspended
Burien
Providence Regional Cancer System-Centralia
Suspended
Centralia
Swedish Cancer Institute-Edmonds
Suspended
Edmonds
Saint Elizabeth Hospital
Suspended
Enumclaw
Providence Regional Cancer Partnership
Suspended
Everett
Saint Francis Hospital
Suspended
Federal Way
Swedish Cancer Institute-Issaquah
Suspended
Issaquah
Kadlec Clinic Hematology and Oncology
Suspended
Kennewick
Providence Regional Cancer System-Lacey
Suspended
Lacey
Saint Clare Hospital
Suspended
Lakewood
PeaceHealth Saint John Medical Center
Suspended
Longview
Harrison HealthPartners Hematology and Oncology-Poulsbo
Active, not recruiting
Poulsbo
Kaiser Permanente Washington
Active, not recruiting
Seattle
Pacific Gynecology Specialists
Suspended
Seattle
Seattle Children's Hospital
Suspended
Seattle
Swedish Medical Center-Ballard Campus
Suspended
Seattle
Swedish Medical Center-Cherry Hill
Suspended
Seattle
Swedish Medical Center-First Hill
Suspended
Seattle
Providence Regional Cancer System-Shelton
Suspended
Shelton
MultiCare Deaconess Cancer and Blood Specialty Center - Downtown
Suspended
Spokane
MultiCare Deaconess Cancer and Blood Specialty Center - North
Suspended
Spokane
Providence Sacred Heart Medical Center and Children's Hospital
Suspended
Spokane
MultiCare Deaconess Cancer and Blood Specialty Center - Valley
Suspended
Spokane Valley
Franciscan Research Center-Northwest Medical Plaza
Suspended
Tacoma
Madigan Army Medical Center
Suspended
Tacoma
Mary Bridge Children's Hospital and Health Center
Suspended
Tacoma
Northwest Medical Specialties PLLC
Suspended
Tacoma
PeaceHealth Southwest Medical Center
Suspended
Vancouver
Providence Saint Mary Regional Cancer Center
Suspended
Walla Walla
North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
Suspended
Yakima
Providence Regional Cancer System-Yelm
Suspended
Yelm
Wisconsin
Green Bay Oncology at Saint Vincent Hospital
Recruiting
Green Bay
Saint Vincent Hospital Cancer Center at Saint Mary's
Suspended
Green Bay
Saint Vincent Hospital Cancer Center Green Bay
Suspended
Green Bay
UW Cancer Center Johnson Creek
Suspended
Johnson Creek
University of Wisconsin Carbone Cancer Center
Recruiting
Madison
Holy Family Memorial Hospital
Suspended
Manitowoc
Saint Vincent Hospital Cancer Center at Marinette
Suspended
Marinette
Marshfield Medical Center-Marshfield
Suspended
Marshfield
Children's Hospital of Wisconsin
Suspended
Milwaukee
Saint Vincent Hospital Cancer Center at Oconto Falls
Suspended
Oconto Falls
HSHS Saint Nicholas Hospital
Suspended
Sheboygan
Saint Vincent Hospital Cancer Center at Sturgeon Bay
Suspended
Sturgeon Bay
West Virginia
United Hospital Center
Suspended
Bridgeport
West Virginia University Charleston Division
Suspended
Charleston
WVUH-Berkely Medical Center
Suspended
Martinsburg
West Virginia University Healthcare
Suspended
Morgantown
Camden Clark Medical Center
Suspended
Parkersburg
Other Locations
Australia
Monash Medical Center-Clayton Campus
Recruiting
Clayton
John Hunter Children's Hospital
Recruiting
Hunter Regional Mail Centre
Royal Children's Hospital
Recruiting
Parkville
Perth Children's Hospital
Recruiting
Perth
Princess Margaret Hospital for Children
Active, not recruiting
Perth
Sydney Children's Hospital
Recruiting
Randwick
Queensland Children's Hospital
Recruiting
South Brisbane
The Children's Hospital at Westmead
Recruiting
Westmead
Canada
Alberta Children's Hospital
Recruiting
Calgary
University of Alberta Hospital
Recruiting
Edmonton
IWK Health Centre
Recruiting
Halifax
McMaster Children's Hospital at Hamilton Health Sciences
Recruiting
Hamilton
Kingston Health Sciences Centre
Recruiting
Kingston
Children's Hospital
Recruiting
London
Centre Hospitalier Universitaire Sainte-Justine
Recruiting
Montreal
The Montreal Children's Hospital of the MUHC
Recruiting
Montreal
Children's Hospital of Eastern Ontario
Recruiting
Ottawa
Centre Hospitalier Universitaire de Quebec
Recruiting
Quebec
Janeway Child Health Centre
Recruiting
Saint John's
Hospital for Sick Children
Recruiting
Toronto
Odette Cancer Centre- Sunnybrook Health Sciences Centre
Suspended
Toronto
University Health Network-Princess Margaret Hospital
Recruiting
Toronto
British Columbia Children's Hospital
Suspended
Vancouver
CancerCare Manitoba
Recruiting
Winnipeg
Japan
Saitama Children's Medical Center
Recruiting
Chuo-ku
Kyushu Univeristy
Recruiting
Higashi-ku
Hiroshima University Hospital
Recruiting
Hiroshima City
Hyogo Prefectural Kobe Children's Hospital
Recruiting
Kobe
Kyoto Perfectural University of Medicine
Recruiting
Kyoto
Niigata Cancer Centre
Recruiting
Niigata
Hyogo College of Medicine
Recruiting
Nishinomiya, Hyogo
Osaka City General Hospital
Recruiting
Osaka City
Saitama Medical University International Medical Center
Recruiting
Saitama
Tohoku University School of Medicine
Recruiting
Sendai
Keio University
Recruiting
Shinjuku-ku
Kokuritsu Seiiku Medical Research Center Hospital
Recruiting
Tokyo
University of Tsukuba Hospital
Recruiting
Tsukuba
Kanagawa Children's Medical Center
Recruiting
Yokohama
New Zealand
Christchurch Hospital
Recruiting
Christchurch
Starship Children's Hospital
Recruiting
Grafton
Puerto Rico
HIMA San Pablo Oncologic Hospital
Suspended
Caguas
San Jorge Children's Hospital
Active, not recruiting
San Juan
Saudi Arabia
King Faisal Specialist Hospital and Research Centre
Recruiting
Riyadh
United Kingdom
Addenbrookes Hospital-Medical School
Recruiting
Cambridge
Royal Hospital for Children and Young People
Recruiting
Edinburgh
Saint Bartholomew's Hospital
Recruiting
London
University College London Hospitals NHS Trust - Foley Street
Recruiting
London
Saint James's University Hospital
Recruiting
West Yorkshire
Time Frame
Start Date: May 8, 2017
Estimated Completion Date: June 30, 2027
Participants
Target number of participants: 2059
Treatments
Experimental: Arm I (bleomycin, carboplatin, etoposide)
Patients receive bleomycin IV over 10 minutes and carboplatin IV over 1 hour on day 1. Patients also receive etoposide IV over 1-2 hours on days 1-5. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo CT, MRI, and/or chest x-ray as well as blood sample collection throughout the trial. Patients may also undergo a tumor biopsy throughout the trial. Patients undergo a pulmonary function test on study.
Experimental: Arm II (bleomycin, etoposide, cisplatin)
Patients receive bleomycin IV over 10 minutes on day 1. Patients also receive etoposide IV over 1-2 hours and cisplatin IV over 1-3 hours on days 1-5. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo CT, MRI, and/or chest x-ray as well as blood sample collection throughout the trial. Patients may also undergo a tumor biopsy throughout the trial. Patients undergo a pulmonary function test on study.
Experimental: Arm III (bleomycin, etoposide, carboplatin)
Patients receive bleomycin IV over 10 minutes on days 1, 8, and 15, etoposide IV over 1-2 hours on days 1-5, and carboplatin IV over 1 hour on day 1. Treatment repeats every 21 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo CT, MRI, and/or chest x-ray as well as blood sample collection throughout the trial. Patients may also undergo a tumor biopsy throughout the trial. Patients undergo a pulmonary function test on study.
Experimental: Arm IV (bleomycin, etoposide, cisplatin)
Patients receive bleomycin IV over 10 minutes on days 1, 8, and 15, etoposide IV over 1-2 hours on days 1-5, and cisplatin IV over 1-3 hours on days 1-5. Treatment repeats every 21 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo CT, MRI, and/or chest x-ray as well as blood sample collection throughout the trial. Patients may also undergo a tumor biopsy throughout the trial. Patients undergo a pulmonary function test on study.
Experimental: Low-Risk (observation)
Patients with low-risk stage I grade 2, 3 ovarian immature teratoma or stage I non-seminoma or seminoma MGCTs undergo observation and can transfer to standard risk arm when eligibility criteria are met. Patients with stage I seminoma testicular MGCT undergo observation, and those with residual/recurrent disease are treated at the discretion of their physician. Patients undergo CT, MRI, and/or chest x-ray as well as blood sample collection throughout the trial. Patients may also undergo a tumor biopsy throughout the trial.
Authors
Samuel O. Anim, Craig Erker, Lisa L. Hartman, Angela R. Girvin, Hamayun Imran, Benjamin B. Bridges, Alok K. Kothari, Carola A. Arndt, Kelly L. Vallance, Elyssa M. Rubin, Haydar A. Frangoul, Laura L. Holman, Ashley E. Meyer, Alberto S. Pappo, Nina S. Kadan-Lottick, Alissa Kahn, Corina E. Gonzalez, Kristin K. Zorn, Eric C. Larsen, Kathryn L. Laurie, Marcio H. Malogolowkin, Jessica C. Hochberg, Anna B. Pawlowska, Douglas S. Hawkins, Mary L. Schmidt, Eduard H. Panosyan, Vinod K. Gidvani-Diaz, Julio C. Barredo, Afshan A. Ali, Vlad C. Radulescu, Matthew A. Kutny, Eric J. Lowe, William A. May, Gary D. Crouch, Nadine P. SantaCruz, Mariko Sato, Caroline Y. Hu, Bryan A. Faller, Ashok B. Raj, Frances Austin, Michael Humeniuk, Mark S. Shahin, Jessica M. Valdez, Jessica Boklan, Keith J. August, Chana L. Glasser, Kishor M. Bhende, Lisa Gennarini, Stanton C. Goldman, Sushmita Nair, Thomas W. McLean, Michael S. Isakoff, John J. Letterio, Justine M. Kahn, Kayelyn J. Wagner, Ziad A. Khatib, Mukund G. Dole, David L. Becton, Laura E. Agresta, Adit L. Tal, Lars M. Wagner, Phillip E. Barnette, Matthew Dietz, Rabi Hanna, Hardeo K. Panchoosingh, Timothy C. Griffin, Katrina Winsnes, Mehmet S. Copur, Robin D. Hanson, Vonda L. Crouse, Vincent F. Giusti, Scott C. Borinstein, Juan F. Rico, Robert J. Hamilton, Ranjan Bista, Doured Daghistani, Jennifer A. Domm, Don E. Eslin, William B. Slayton, Lolie C. Yu, Julia Glade-Bender, Mark J. Mogul, Kamnesh R. Pradhan, Iftikhar Hanif, Aron Flagg, Holly E. Pariury, Catherine A. Long, Mark A. Ranalli, David S. Dickens, Pooja Hingorani, Erin K. Barr, Samer S. Kasbari, Leo Mascarenhas, Peri Kamalakar, Ray C. Pais, Laura E. Hogan, Jamie L. Dargart, Sheri L. Spunt, Adonis N. Lorenzana, Timothy D. Moore, Jason Law, Duncan S. Stearns, Paul M. Barr, Emily C. McClung, Andrew L. Pendleton, Bethany G. Sleckman, Shelton A. Viola, Krishna C. Alluri, Laura B. Huffman, Yoko T. Udaka, Jose M. Esquilin, Susan L. Cohn, Jeffery D. Hanrahan, Aarati V. Rao, Joseph C. Torkildson, Linda C. Stork, Michelle A. Manalang, Clare J. Twist, Craig Lotterman, Erlyn C. Smith, Aniket Saha, Nagesh H. Jayaram, Burton E. Appel, Colleen H. McDonough, Sandeep Batra, Aghiad Chamdin, Emily G. Greengard, Thomas B. Russell, Victor A. Lewis, John R. Hill, Meghann P. McManus, Thomas A. Olson, Nicholas W. McGregor, Jennifer L. Reichek, James T. Badgett, Robert G. Irwin, Carla B. Golden, Elizabeth D. Alva, Susan E. Spiller, Douglas J. Scothorn, Eugene Suh, Priya Mahajan, Robert D. Siegel, Jonathan L. Metts, Fouad M. Hajjar, Judy L. Felgenhauer, Jacob A. Troutman, Pamela H. Kempert, Minnie Abromowitch, Jean A. Hurteau, Wade T. Kyono, Amy A. Smith, Kara-Marie H. Delaney, William D. Roberts, Bethany M. Mikles, Mahmut Y. Celiker, Gregory P. Brandt, Alan D. Friedman, Lisa M. McGregor, Robert M. Cooper, Nichole L. Bryant, Santosh S. Hanmod, Wendy L. Woods-Swafford, Susan G. Kreissman, Jeffrey R. Andolina, Sara Chaffee, Laura A. Campbell, Jennifer J. Welch, Jagadeesh Ramdas, Philip M. Monteleone, Stuart L. Cramer, Nabil Adra, Jeffrey A. Toretsky, Jay Michael S. Balagtas, Lauren M. Vasta, Joel A. Kaplan, Guy H. Grayson, Jean M. Tersak, Gregory E. Halligan, Bassem I. Razzouk, Brenda J. Wittman, Robert J. Hayashi, Dan S. Zuckerman, Yung S. Yim, Samuel J. Milanovich, Katharine Offer, Alan K. Ikeda, Samantha L. Mallory, Enrique A. Escalon, Dana A. Obzut, Nkechi I. Mba, Nicholas G. Cost, Janice F. Olson, Laura K. Gowans, Rebecca E. McFall, Narayana Gowda, Michael K. Richards, Steven J. Kuerbitz, Meghen B. Browning, James I. Geller, Alice Lee, Lauren R. Weintraub, Mark E. Weinblatt, Jeffrey H. Schwartz, Jason M. Fixler, Sharon L. Gardner, Jill C. Beck, Jonathan E. Wickiser, Jennifer J. Clark, Julie Kim, Alexander B. Olawaiye, Jessica A. Bell, Frank M. Balis, Anishka D'Souza, Teena Bhatla, Teresa A. York, Jessica L. Heath, Nicola M. Spirtos, Albert Kheradpour, Jeffrey S. Dome, Melissa A. Forouhar, Mohamad H. Badawi, Pillai Pallavi Madhusoodhan, Steven L. Halpern, Anita Ravipati, Richard L. Deming, Stefanie R. Lowas, Farzana Pashankar, John J. Gregory, Arun A. Rangaswami, Lydia A. Boateng, Emad K. Salman, Stuart H. Gold, Amy C. Fowler, Luis A. Clavell, Douglas R. Strother, Jhon A. Guerra, Kenneth B. De Santes, Felipe S. Bautista-Otanez, Christopher P. Keuker, Tanya R. Brown, Stephan R. Paul, Felicia L. Wilson, Sara J. Stoneham, Steven A. Foresto, Elizabeth L. Hesketh, Karen S. Fernandez, A. L. Frazier, Rebecca O. Clark, Timothy P. Garrington, Jennifer L. Mayer, Jacqueline N. Casillas, Paul J. Wood, Ashley Chopek, Lisa A. Goodyear, Sharon B. Abish, Carolyn F. Levy, Mark A. Winstanley, Mary T. Jenkins Vogel, Laura Wheaton, Ayman A. El-Sheikh, Jordan R. Hansford, Carol A. Portwine, Yvan Samson, Anne-Marie R. Langevin, Donna L. Johnston, David B. Dix, Pedro A. De Alarcon, Tatsuo Kuroda, Shannon M. Cohn, Susanna V. Ulahannan, Najat C. Daw, Tristan Pettit, Kenneth B. DeSantes, Uma H. Athale, Jacqueline M. Kraveka, Fataneh (Fae) Majlessipour, Jennifer J. Greene Welch, Shayna M. Zelcer, Rene Y. McNall-Knapp, Bhavna Padhye, Furqan Shaikh, David E. Kram, Kathleen J. Yost, Jaime M. Libes, Marianne B. Phillips, Draga Barbaric, Julia L. Glade Bender, Helen Irving, Archana Sharma, Mohamad M. Al-Rahawan, Hector M. Rodriguez-Cortes, Mariana P. Silva, Rama Jasty, Sarah J. McKillop, Ramamoorthy Nagasubramanian, Sarah E. Leary, Allan L. Covens, Geoff D. Cuvelier, Anderson (Andy) B. Collier, Bruno Michon, Conrad V. Fernandez, Kenneth Lieuw, Brandon D. Bernard
Sponsors
Leads: Children's Oncology Group
Collaborators: National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov

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