Actively Recruiting
A Study Using Risk Factors to Determine Treatment for Children With Favorable Histology Wilms Tumors (FHWT)
Led by Children's Oncology Group · Updated on 2026-05-05
1656
Participants Needed
159
Research Sites
304 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This phase III trial studies using risk factors in determining treatment for children with favorable tissue (histology) Wilms tumors (FHWT). Wilms Tumor is the most common type of kidney cancer in children, and FHWT is the most common subtype. Previous large clinical trials have established treatment plans that are likely to cure most children with FHWT, however some children still have their cancer come back (called relapse) and not all survive. Previous research has identified features of FHWT that are associated with higher or lower risks of relapse. The term "risk" refers to the chance of the cancer coming back after treatment. Using results of tumor histology tests, biology tests, and response to therapy may be able to improve treatment for children with FHWT.
CONDITIONS
Official Title
A Study Using Risk Factors to Determine Treatment for Children With Favorable Histology Wilms Tumors (FHWT)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must be enrolled on APEC14B1 and consent to Part A - Eligibility Screening before joining this study.
- Patients must be younger than 30 years old at enrollment.
- Newly diagnosed Stage I-IV Favorable Histology Wilms Tumor confirmed by central review.
- Must receive a qualifying initial stratum assignment within 14 days after nephrectomy or biopsy.
- Diagnostic tumor samples must be sent for molecular testing for specific genetic markers.
- Patients with upfront nephrectomy must have at least one lymph node sampled and confirmed.
- Karnofsky or Lansky performance status of 50 or higher depending on age.
- For those receiving chemotherapy, liver function and heart function tests must meet specified limits.
- HIV-infected patients on effective therapy with undetectable viral load within 6 months are eligible.
- Patients and/or guardians must sign informed consent.
- All regulatory and institutional requirements for human studies must be met.
You will not qualify if you...
- Patients with Stage V bilateral Wilms Tumor.
- Patients unable to comply with study procedures.
- Patients with uncontrolled illnesses including symptomatic congestive heart failure.
- Stage I FHWT patients with known or suspected Wilms Tumor predisposition syndromes or conditions are excluded from nephrectomy-only arm.
- Patients treated with partial nephrectomy at initial diagnosis are excluded from nephrectomy-only arm.
- Patients with lung metastases who had complete resection of all lung nodules prior to lung imaging after Cycle 2 will be taken off protocol.
- Patients with known Charcot-Marie-Tooth syndrome.
- Patients who had prior tumor-directed chemotherapy or radiotherapy for this diagnosis (except emergent therapy).
- Patients who will require doxorubicin in this study but have had it before for another diagnosis.
- Patients receiving chemotherapy for another diagnosis.
- Female patients who are pregnant or lactating.
- Sexually active patients of reproductive potential who have not agreed to use effective contraception during the study.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 159 locations
1
Children's Hospital of Alabama
Birmingham, Alabama, United States, 35233
Actively Recruiting
2
USA Health Strada Patient Care Center
Mobile, Alabama, United States, 36604
Actively Recruiting
3
Providence Alaska Medical Center
Anchorage, Alaska, United States, 99508
Actively Recruiting
4
Banner Children's at Desert
Mesa, Arizona, United States, 85202
Actively Recruiting
5
Phoenix Childrens Hospital
Phoenix, Arizona, United States, 85016
Actively Recruiting
6
Arkansas Children's Hospital
Little Rock, Arkansas, United States, 72202-3591
Actively Recruiting
7
Kaiser Permanente Downey Medical Center
Downey, California, United States, 90242
Actively Recruiting
8
Loma Linda University Medical Center
Loma Linda, California, United States, 92354
Actively Recruiting
9
Miller Children's and Women's Hospital Long Beach
Long Beach, California, United States, 90806
Actively Recruiting
10
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Actively Recruiting
11
Valley Children's Hospital
Madera, California, United States, 93636
Actively Recruiting
12
UCSF Benioff Children's Hospital Oakland
Oakland, California, United States, 94609
Actively Recruiting
13
Kaiser Permanente-Oakland
Oakland, California, United States, 94611
Actively Recruiting
14
Children's Hospital of Orange County
Orange, California, United States, 92868
Actively Recruiting
15
Lucile Packard Children's Hospital Stanford University
Palo Alto, California, United States, 94304
Actively Recruiting
16
University of California Davis Comprehensive Cancer Center
Sacramento, California, United States, 95817
Actively Recruiting
17
Rady Children's Hospital - San Diego
San Diego, California, United States, 92123
Actively Recruiting
18
UCSF Medical Center-Mission Bay
San Francisco, California, United States, 94158
Actively Recruiting
19
Children's Hospital Colorado
Aurora, Colorado, United States, 80045
Actively Recruiting
20
Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center
Denver, Colorado, United States, 80218
Actively Recruiting
21
Connecticut Children's Medical Center
Hartford, Connecticut, United States, 06106
Actively Recruiting
22
Yale University
New Haven, Connecticut, United States, 06520
Actively Recruiting
23
Alfred I duPont Hospital for Children
Wilmington, Delaware, United States, 19803
Actively Recruiting
24
Children's National Medical Center
Washington D.C., District of Columbia, United States, 20010
Actively Recruiting
25
Broward Health Medical Center
Fort Lauderdale, Florida, United States, 33316
Actively Recruiting
26
Golisano Children's Hospital of Southwest Florida
Fort Myers, Florida, United States, 33908
Actively Recruiting
27
UF Health Cancer Institute - Gainesville
Gainesville, Florida, United States, 32610
Actively Recruiting
28
Memorial Regional Hospital/Joe DiMaggio Children's Hospital
Hollywood, Florida, United States, 33021
Actively Recruiting
29
Nemours Children's Clinic-Jacksonville
Jacksonville, Florida, United States, 32207
Actively Recruiting
30
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, United States, 33136
Actively Recruiting
31
Nicklaus Children's Hospital
Miami, Florida, United States, 33155
Actively Recruiting
32
Arnold Palmer Hospital for Children
Orlando, Florida, United States, 32806
Actively Recruiting
33
Nemours Children's Hospital
Orlando, Florida, United States, 32827
Actively Recruiting
34
Nemours Children's Clinic - Pensacola
Pensacola, Florida, United States, 32504
Actively Recruiting
35
Johns Hopkins All Children's Hospital
St. Petersburg, Florida, United States, 33701
Actively Recruiting
36
Saint Joseph's Hospital/Children's Hospital-Tampa
Tampa, Florida, United States, 33607
Actively Recruiting
37
Saint Mary's Medical Center
West Palm Beach, Florida, United States, 33407
Actively Recruiting
38
Children's Healthcare of Atlanta - Arthur M Blank Hospital
Atlanta, Georgia, United States, 30329
Actively Recruiting
39
Augusta University Medical Center
Augusta, Georgia, United States, 30912
Actively Recruiting
40
Atrium Health Navicent
Macon, Georgia, United States, 31201
Actively Recruiting
41
Memorial Health University Medical Center
Savannah, Georgia, United States, 31404
Actively Recruiting
42
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, United States, 96826
Actively Recruiting
43
Saint Luke's Cancer Institute - Boise
Boise, Idaho, United States, 83712
Actively Recruiting
44
Lurie Children's Hospital-Chicago
Chicago, Illinois, United States, 60611
Actively Recruiting
45
University of Illinois
Chicago, Illinois, United States, 60612
Actively Recruiting
46
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, United States, 60637
Actively Recruiting
47
Advocate Children's Hospital-Oak Lawn
Oak Lawn, Illinois, United States, 60453
Actively Recruiting
48
Advocate Children's Hospital-Park Ridge
Park Ridge, Illinois, United States, 60068
Actively Recruiting
49
Saint Jude Midwest Affiliate
Peoria, Illinois, United States, 61637
Actively Recruiting
50
Riley Hospital for Children
Indianapolis, Indiana, United States, 46202
Actively Recruiting
51
Blank Children's Hospital
Des Moines, Iowa, United States, 50309
Actively Recruiting
52
University of Iowa/Holden Comprehensive Cancer Center
Iowa City, Iowa, United States, 52242
Actively Recruiting
53
University of Kentucky/Markey Cancer Center
Lexington, Kentucky, United States, 40536
Not Yet Recruiting
54
Children's Hospital New Orleans
New Orleans, Louisiana, United States, 70118
Actively Recruiting
55
Ochsner Medical Center Jefferson
New Orleans, Louisiana, United States, 70121
Actively Recruiting
56
Maine Children's Cancer Program
Scarborough, Maine, United States, 04074
Actively Recruiting
57
University of Maryland/Greenebaum Cancer Center
Baltimore, Maryland, United States, 21201
Actively Recruiting
58
Sinai Hospital of Baltimore
Baltimore, Maryland, United States, 21215
Actively Recruiting
59
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland, United States, 21287
Actively Recruiting
60
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States, 02114
Actively Recruiting
61
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
62
Baystate Medical Center
Springfield, Massachusetts, United States, 01199
Actively Recruiting
63
UMass Memorial Medical Center - University Campus
Worcester, Massachusetts, United States, 01655
Actively Recruiting
64
C S Mott Children's Hospital
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
65
Children's Hospital of Michigan
Detroit, Michigan, United States, 48201
Actively Recruiting
66
Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital
Grand Rapids, Michigan, United States, 49503
Actively Recruiting
67
Bronson Methodist Hospital
Kalamazoo, Michigan, United States, 49007
Actively Recruiting
68
Children's Hospitals and Clinics of Minnesota - Minneapolis
Minneapolis, Minnesota, United States, 55404
Actively Recruiting
69
University of Minnesota/Masonic Cancer Center
Minneapolis, Minnesota, United States, 55455
Actively Recruiting
70
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Actively Recruiting
71
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216
Actively Recruiting
72
University of Missouri Children's Hospital
Columbia, Missouri, United States, 65212
Actively Recruiting
73
Children's Mercy Hospitals and Clinics
Kansas City, Missouri, United States, 64108
Actively Recruiting
74
Cardinal Glennon Children's Medical Center
St Louis, Missouri, United States, 63104
Actively Recruiting
75
Washington University School of Medicine
St Louis, Missouri, United States, 63110
Actively Recruiting
76
Children's Hospital and Medical Center of Omaha
Omaha, Nebraska, United States, 68114
Actively Recruiting
77
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198
Actively Recruiting
78
Alliance for Childhood Diseases/Cure 4 the Kids Foundation
Las Vegas, Nevada, United States, 89135
Actively Recruiting
79
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
Lebanon, New Hampshire, United States, 03756
Actively Recruiting
80
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
Actively Recruiting
81
Morristown Medical Center
Morristown, New Jersey, United States, 07960
Actively Recruiting
82
Jersey Shore Medical Center
Neptune City, New Jersey, United States, 07753
Actively Recruiting
83
Saint Peter's University Hospital
New Brunswick, New Jersey, United States, 08901
Actively Recruiting
84
Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital
New Brunswick, New Jersey, United States, 08903
Actively Recruiting
85
Newark Beth Israel Medical Center
Newark, New Jersey, United States, 07112
Actively Recruiting
86
Albany Medical Center
Albany, New York, United States, 12208
Actively Recruiting
87
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
Actively Recruiting
88
NYU Langone Hospital - Long Island
Mineola, New York, United States, 11501
Actively Recruiting
89
The Steven and Alexandra Cohen Children's Medical Center of New York
New Hyde Park, New York, United States, 11040
Actively Recruiting
90
Laura and Isaac Perlmutter Cancer Center at NYU Langone
New York, New York, United States, 10016
Actively Recruiting
91
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
92
University of Rochester
Rochester, New York, United States, 14642
Actively Recruiting
93
Stony Brook University Medical Center
Stony Brook, New York, United States, 11794
Actively Recruiting
94
State University of New York Upstate Medical University
Syracuse, New York, United States, 13210
Actively Recruiting
95
New York Medical College
Valhalla, New York, United States, 10595
Actively Recruiting
96
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, United States, 27599
Actively Recruiting
97
Carolinas Medical Center/Levine Cancer Institute
Charlotte, North Carolina, United States, 28203
Actively Recruiting
98
Novant Health Presbyterian Medical Center
Charlotte, North Carolina, United States, 28204
Actively Recruiting
99
Duke University Medical Center
Durham, North Carolina, United States, 27710
Actively Recruiting
100
East Carolina University
Greenville, North Carolina, United States, 27834
Actively Recruiting
101
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
Actively Recruiting
102
Children's Hospital Medical Center of Akron
Akron, Ohio, United States, 44308
Actively Recruiting
103
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Actively Recruiting
104
Rainbow Babies and Childrens Hospital
Cleveland, Ohio, United States, 44106
Actively Recruiting
105
Dayton Children's Hospital
Dayton, Ohio, United States, 45404
Actively Recruiting
106
ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital
Toledo, Ohio, United States, 43606
Actively Recruiting
107
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
Actively Recruiting
108
Legacy Emanuel Children's Hospital
Portland, Oregon, United States, 97227
Actively Recruiting
109
Oregon Health and Science University
Portland, Oregon, United States, 97239
Actively Recruiting
110
Geisinger Medical Center
Danville, Pennsylvania, United States, 17822
Actively Recruiting
111
Penn State Children's Hospital
Hershey, Pennsylvania, United States, 17033
Actively Recruiting
112
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
113
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, United States, 15224
Actively Recruiting
114
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
Actively Recruiting
115
Prisma Health Richland Hospital
Columbia, South Carolina, United States, 29203
Actively Recruiting
116
BI-LO Charities Children's Cancer Center
Greenville, South Carolina, United States, 29605
Actively Recruiting
117
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota, United States, 57117-5134
Actively Recruiting
118
T C Thompson Children's Hospital
Chattanooga, Tennessee, United States, 37403
Actively Recruiting
119
East Tennessee Childrens Hospital
Knoxville, Tennessee, United States, 37916
Actively Recruiting
120
Saint Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105
Actively Recruiting
121
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, United States, 37232
Actively Recruiting
122
Texas Tech University Health Sciences Center-Amarillo
Amarillo, Texas, United States, 79106
Actively Recruiting
123
Dell Children's Medical Center of Central Texas
Austin, Texas, United States, 78723
Actively Recruiting
124
Driscoll Children's Hospital
Corpus Christi, Texas, United States, 78411
Actively Recruiting
125
Medical City Dallas Hospital
Dallas, Texas, United States, 75230
Actively Recruiting
126
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas, United States, 75390
Actively Recruiting
127
Cook Children's Medical Center
Fort Worth, Texas, United States, 76104
Actively Recruiting
128
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
129
Covenant Children's Hospital
Lubbock, Texas, United States, 79410
Actively Recruiting
130
UMC Cancer Center / UMC Health System
Lubbock, Texas, United States, 79415
Actively Recruiting
131
Children's Hospital of San Antonio
San Antonio, Texas, United States, 78207
Actively Recruiting
132
Methodist Children's Hospital of South Texas
San Antonio, Texas, United States, 78229
Actively Recruiting
133
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78229
Actively Recruiting
134
Primary Children's Hospital
Salt Lake City, Utah, United States, 84113
Actively Recruiting
135
University of Vermont and State Agricultural College
Burlington, Vermont, United States, 05405
Actively Recruiting
136
University of Virginia Cancer Center
Charlottesville, Virginia, United States, 22908
Actively Recruiting
137
Inova Fairfax Hospital
Falls Church, Virginia, United States, 22042
Actively Recruiting
138
Children's Hospital of The King's Daughters
Norfolk, Virginia, United States, 23507
Actively Recruiting
139
VCU Massey Comprehensive Cancer Center
Richmond, Virginia, United States, 23298
Actively Recruiting
140
Carilion Children's
Roanoke, Virginia, United States, 24014
Actively Recruiting
141
Seattle Children's Hospital
Seattle, Washington, United States, 98105
Actively Recruiting
142
Providence Sacred Heart Medical Center and Children's Hospital
Spokane, Washington, United States, 99204
Actively Recruiting
143
Mary Bridge Children's Hospital and Health Center
Tacoma, Washington, United States, 98405
Actively Recruiting
144
Saint Vincent Hospital Cancer Center Green Bay
Green Bay, Wisconsin, United States, 54301
Actively Recruiting
145
University of Wisconsin Carbone Cancer Center - University Hospital
Madison, Wisconsin, United States, 53792
Actively Recruiting
146
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
147
Queensland Children's Hospital
South Brisbane, Queensland, Australia, 4101
Actively Recruiting
148
Alberta Children's Hospital
Calgary, Alberta, Canada, T3B 6A8
Actively Recruiting
149
University of Alberta Hospital
Edmonton, Alberta, Canada, T6G 2B7
Actively Recruiting
150
CancerCare Manitoba
Winnipeg, Manitoba, Canada, R3E 0V9
Actively Recruiting
151
IWK Health Centre
Halifax, Nova Scotia, Canada, B3K 6R8
Actively Recruiting
152
McMaster Children's Hospital at Hamilton Health Sciences
Hamilton, Ontario, Canada, L8N 3Z5
Actively Recruiting
153
Children's Hospital
London, Ontario, Canada, N6A 5W9
Actively Recruiting
154
Children's Hospital of Eastern Ontario
Ottawa, Ontario, Canada, K1H 8L1
Actively Recruiting
155
Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8
Actively Recruiting
156
The Montreal Children's Hospital of the MUHC
Montreal, Quebec, Canada, H3H 1P3
Actively Recruiting
157
Centre Hospitalier Universitaire Sainte-Justine
Montreal, Quebec, Canada, H3T 1C5
Actively Recruiting
158
Centre Hospitalier Universitaire de Sherbrooke-Fleurimont
Sherbrooke, Quebec, Canada, J1H 5N4
Actively Recruiting
159
CHU de Quebec-Centre Hospitalier de l'Universite Laval (CHUL)
Québec, Canada, G1V 4G2
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
48
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