Actively Recruiting
A Phase 3 Study of Chemotherapy for Newly Diagnosed Very Low-Risk and Low-Risk Fusion Negative Rhabdomyosarcoma
Led by Children's Oncology Group · Updated on 2026-05-05
205
Participants Needed
180
Research Sites
N/A
Total Duration
On this page
Sponsors
C
Children's Oncology Group
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying very low-risk and low-risk fusion negative rhabdomyosarcoma, a type of soft tissue cancer, to maintain excellent treatment outcomes while reducing therapy burdens. This phase III trial also evaluates how well patients with certain DNA mutations respond to different chemotherapy regimens and examines the use of centralized molecular risk stratification in treatment planning. The study aims to improve outcomes by adjusting therapy intensity based on molecular features. Patients are assigned to one of three treatment regimens based on their risk level and mutation status. Very low-risk patients receive vincristine and dactinomycin over 24 weeks in 8 cycles. Low-risk patients receive 12 weeks of vincristine, dactinomycin, and cyclophosphamide followed by 12 weeks of vincristine and dactinomycin, totaling 8 cycles. Patients with MYOD1 or TP53 mutations switch to an intensified 12-13 cycle regimen including vincristine, dactinomycin, and cyclophosphamide. Radiation therapy may be given at cycle 5 for some patients. Treatments are administered intravenously every 21 days. Throughout the study, participants undergo CT scans, MRI, bone scans, PET scans, and tumor biopsies to monitor disease status. Blood and tissue samples are collected at various times for research purposes. Researchers measure failure-free survival and overall survival over several years to assess treatment success. The trial lasts up to five years with ongoing assessments to track patient outcomes and safety.
CONDITIONS
Brief Title
Chemotherapy for the Treatment of Patients With Newly Diagnosed Very Low-Risk and Low Risk Fusion Negative Rhabdomyosarcoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Enrolled in APEC14B1 and consented to Molecular Characterization Initiative before this trial
- 21 years old or younger at enrollment
- Newly diagnosed with embryonal rhabdomyosarcoma, spindle cell/sclerosing RMS, or FOXO1 fusion negative alveolar RMS
- Evaluated for stage and clinical group as per study definitions
- For paratesticular tumors in patients 10 years or older without nodal involvement, ipsilateral retroperitoneal lymph node sampling required
- Regional lymph node sampling required for extremity tumors
- Enlarged nodes must be sampled for evaluation
- Lansky or Karnofsky performance status score of 50 or higher
- Peripheral absolute neutrophil count (ANC) of 750/uL or higher
- Platelet count of 75,000/uL or higher without transfusion
- Adequate kidney function as defined by creatinine clearance or serum creatinine limits by age and gender
- Total bilirubin no more than 1.5 times the upper limit of normal (ULN), or less than 3 times ULN if biliary obstruction
- Serum glutamate pyruvate transaminase (SGPT/ALT) no more than 135 U/L, or less than 3 times ULN if biliary obstruction
- Signed informed consent by patient or guardian
- Meets all institutional, FDA, and NCI requirements for human studies
You will not qualify if you...
- Prior chemotherapy or radiation therapy for cancer before enrollment (surgery alone allowed)
- Unable to undergo radiation therapy if needed
- Use of moderate to strong CYP3A4 inhibitors or inducers within 7 days prior to enrollment
- Evidence of uncontrolled infection
- Pregnant female patients
- Lactating females planning to breastfeed
- Sexually active patients of reproductive potential not agreeing to effective contraception during study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to approximately 39 weeks (12-13 cycles of 21 days each)
Participants receive chemotherapy regimens based on their risk group. This includes vincristine, dactinomycin, and cyclophosphamide administered intravenously in repeated 21-day cycles for 8 to 13 cycles depending on the assigned regimen and mutation status. Radiation therapy may be given during treatment if needed.
Repeated visits every 3 weeks for chemotherapy infusions throughout treatment cycles
Duration - Up to 3 to 5 years post treatment for survival and disease progression assessment
Participants undergo ongoing monitoring with CT scans, MRI, bone scans, PET scans, and tumor biopsies throughout the study to assess treatment response and disease status.
Periodic imaging and biopsy visits throughout study duration
Trial Site Locations
Total: 180 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
Phoenix Childrens Hospital
Phoenix, Arizona, United States, 85016
Actively Recruiting
4
Arkansas Children's Hospital
Little Rock, Arkansas, United States, 72202-3591
Actively Recruiting
5
Kaiser Permanente Downey Medical Center
Downey, California, United States, 90242
Actively Recruiting
6
Loma Linda University Medical Center
Loma Linda, California, United States, 92354
Actively Recruiting
7
Miller Children's and Women's Hospital Long Beach
Long Beach, California, United States, 90806
Actively Recruiting
8
Children's Hospital Los Angeles
Los Angeles, California, United States, 90027
Actively Recruiting
9
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Actively Recruiting
10
Mattel Children's Hospital UCLA
Los Angeles, California, United States, 90095
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
Naval Medical Center -San Diego
San Diego, California, United States, 92134
Actively Recruiting
19
UCSF Medical Center-Mission Bay
San Francisco, California, United States, 94158
Actively Recruiting
20
Children's Hospital Colorado
Aurora, Colorado, United States, 80045
Actively Recruiting
21
Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center
Denver, Colorado, United States, 80218
Actively Recruiting
22
Connecticut Children's Medical Center
Hartford, Connecticut, United States, 06106
Actively Recruiting
23
Yale University
New Haven, Connecticut, United States, 06520
Actively Recruiting
24
Alfred I duPont Hospital for Children
Wilmington, Delaware, United States, 19803
Actively Recruiting
25
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, United States, 20007
Actively Recruiting
26
Children's National Medical Center
Washington D.C., District of Columbia, United States, 20010
Actively Recruiting
27
Broward Health Medical Center
Fort Lauderdale, Florida, United States, 33316
Actively Recruiting
28
Golisano Children's Hospital of Southwest Florida
Fort Myers, Florida, United States, 33908
Actively Recruiting
29
UF Health Cancer Institute - Gainesville
Gainesville, Florida, United States, 32610
Actively Recruiting
30
Memorial Regional Hospital/Joe DiMaggio Children's Hospital
Hollywood, Florida, United States, 33021
Actively Recruiting
31
Nemours Children's Clinic-Jacksonville
Jacksonville, Florida, United States, 32207
Actively Recruiting
32
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, United States, 33136
Actively Recruiting
33
Nicklaus Children's Hospital
Miami, Florida, United States, 33155
Actively Recruiting
34
AdventHealth Orlando
Orlando, Florida, United States, 32803
Actively Recruiting
35
Arnold Palmer Hospital for Children
Orlando, Florida, United States, 32806
Actively Recruiting
36
Nemours Children's Hospital
Orlando, Florida, United States, 32827
Actively Recruiting
37
Nemours Children's Clinic - Pensacola
Pensacola, Florida, United States, 32504
Actively Recruiting
38
Sacred Heart Hospital
Pensacola, Florida, United States, 32504
Suspended
39
Johns Hopkins All Children's Hospital
St. Petersburg, Florida, United States, 33701
Actively Recruiting
40
Saint Joseph's Hospital/Children's Hospital-Tampa
Tampa, Florida, United States, 33607
Actively Recruiting
41
Saint Mary's Medical Center
West Palm Beach, Florida, United States, 33407
Actively Recruiting
42
Children's Healthcare of Atlanta - Arthur M Blank Hospital
Atlanta, Georgia, United States, 30329
Actively Recruiting
43
Atrium Health Navicent
Macon, Georgia, United States, 31201
Actively Recruiting
44
Memorial Health University Medical Center
Savannah, Georgia, United States, 31404
Actively Recruiting
45
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, United States, 96826
Actively Recruiting
46
Saint Luke's Cancer Institute - Boise
Boise, Idaho, United States, 83712
Actively Recruiting
47
Lurie Children's Hospital-Chicago
Chicago, Illinois, United States, 60611
Actively Recruiting
48
University of Illinois
Chicago, Illinois, United States, 60612
Suspended
49
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, United States, 60637
Actively Recruiting
50
Loyola University Medical Center
Maywood, Illinois, United States, 60153
Actively Recruiting
51
Advocate Children's Hospital-Oak Lawn
Oak Lawn, Illinois, United States, 60453
Actively Recruiting
52
Advocate Children's Hospital-Park Ridge
Park Ridge, Illinois, United States, 60068
Actively Recruiting
53
Saint Jude Midwest Affiliate
Peoria, Illinois, United States, 61637
Actively Recruiting
54
Southern Illinois University School of Medicine
Springfield, Illinois, United States, 62702
Actively Recruiting
55
Northwestern Medicine Central DuPage Hospital
Winfield, Illinois, United States, 60190
Actively Recruiting
56
Riley Hospital for Children
Indianapolis, Indiana, United States, 46202
Actively Recruiting
57
Ascension Saint Vincent Indianapolis Hospital
Indianapolis, Indiana, United States, 46260
Actively Recruiting
58
Blank Children's Hospital
Des Moines, Iowa, United States, 50309
Actively Recruiting
59
University of Iowa/Holden Comprehensive Cancer Center
Iowa City, Iowa, United States, 52242
Actively Recruiting
60
Wesley Medical Center
Wichita, Kansas, United States, 67214
Actively Recruiting
61
University of Kentucky/Markey Cancer Center
Lexington, Kentucky, United States, 40536
Actively Recruiting
62
Norton Children's Hospital
Louisville, Kentucky, United States, 40202
Actively Recruiting
63
Children's Hospital New Orleans
New Orleans, Louisiana, United States, 70118
Actively Recruiting
64
Ochsner Medical Center Jefferson
New Orleans, Louisiana, United States, 70121
Actively Recruiting
65
Maine Children's Cancer Program
Scarborough, Maine, United States, 04074
Actively Recruiting
66
University of Maryland/Greenebaum Cancer Center
Baltimore, Maryland, United States, 21201
Actively Recruiting
67
Sinai Hospital of Baltimore
Baltimore, Maryland, United States, 21215
Actively Recruiting
68
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland, United States, 21287
Actively Recruiting
69
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States, 02114
Actively Recruiting
70
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
71
UMass Memorial Medical Center - University Campus
Worcester, Massachusetts, United States, 01655
Actively Recruiting
72
C S Mott Children's Hospital
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
73
Children's Hospital of Michigan
Detroit, Michigan, United States, 48201
Actively Recruiting
74
Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital
Grand Rapids, Michigan, United States, 49503
Actively Recruiting
75
Bronson Methodist Hospital
Kalamazoo, Michigan, United States, 49007
Actively Recruiting
76
Corewell Health Children's
Royal Oak, Michigan, United States, 48073
Actively Recruiting
77
Children's Hospitals and Clinics of Minnesota - Minneapolis
Minneapolis, Minnesota, United States, 55404
Actively Recruiting
78
University of Minnesota/Masonic Cancer Center
Minneapolis, Minnesota, United States, 55455
Actively Recruiting
79
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Actively Recruiting
80
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216
Actively Recruiting
81
Children's Mercy Hospitals and Clinics
Kansas City, Missouri, United States, 64108
Actively Recruiting
82
Cardinal Glennon Children's Medical Center
St Louis, Missouri, United States, 63104
Actively Recruiting
83
Washington University School of Medicine
St Louis, Missouri, United States, 63110
Actively Recruiting
84
Mercy Hospital Saint Louis
St Louis, Missouri, United States, 63141
Actively Recruiting
85
Children's Hospital and Medical Center of Omaha
Omaha, Nebraska, United States, 68114
Actively Recruiting
86
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198
Actively Recruiting
87
Alliance for Childhood Diseases/Cure 4 the Kids Foundation
Las Vegas, Nevada, United States, 89135
Actively Recruiting
88
Summerlin Hospital Medical Center
Las Vegas, Nevada, United States, 89144
Actively Recruiting
89
Renown Regional Medical Center
Reno, Nevada, United States, 89502
Actively Recruiting
90
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
Lebanon, New Hampshire, United States, 03756
Actively Recruiting
91
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
Actively Recruiting
92
Morristown Medical Center
Morristown, New Jersey, United States, 07960
Actively Recruiting
93
Jersey Shore Medical Center
Neptune City, New Jersey, United States, 07753
Actively Recruiting
94
Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital
New Brunswick, New Jersey, United States, 08903
Actively Recruiting
95
Newark Beth Israel Medical Center
Newark, New Jersey, United States, 07112
Actively Recruiting
96
University of New Mexico Cancer Center
Albuquerque, New Mexico, United States, 87106
Actively Recruiting
97
Albany Medical Center
Albany, New York, United States, 12208
Actively Recruiting
98
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
Actively Recruiting
99
The Steven and Alexandra Cohen Children's Medical Center of New York
New Hyde Park, New York, United States, 11040
Actively Recruiting
100
Laura and Isaac Perlmutter Cancer Center at NYU Langone
New York, New York, United States, 10016
Actively Recruiting
101
Mount Sinai Hospital
New York, New York, United States, 10029
Actively Recruiting
102
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
New York, New York, United States, 10032
Actively Recruiting
103
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
104
University of Rochester
Rochester, New York, United States, 14642
Actively Recruiting
105
State University of New York Upstate Medical University
Syracuse, New York, United States, 13210
Actively Recruiting
106
Montefiore Medical Center - Moses Campus
The Bronx, New York, United States, 10467
Actively Recruiting
107
New York Medical College
Valhalla, New York, United States, 10595
Actively Recruiting
108
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, United States, 27599
Actively Recruiting
109
Carolinas Medical Center/Levine Cancer Institute
Charlotte, North Carolina, United States, 28203
Actively Recruiting
110
Novant Health Presbyterian Medical Center
Charlotte, North Carolina, United States, 28204
Actively Recruiting
111
Duke University Medical Center
Durham, North Carolina, United States, 27710
Actively Recruiting
112
East Carolina University
Greenville, North Carolina, United States, 27834
Actively Recruiting
113
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
Actively Recruiting
114
Sanford Broadway Medical Center
Fargo, North Dakota, United States, 58122
Actively Recruiting
115
Children's Hospital Medical Center of Akron
Akron, Ohio, United States, 44308
Actively Recruiting
116
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Actively Recruiting
117
Rainbow Babies and Childrens Hospital
Cleveland, Ohio, United States, 44106
Actively Recruiting
118
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Actively Recruiting
119
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
Actively Recruiting
120
Dayton Children's Hospital
Dayton, Ohio, United States, 45404
Actively Recruiting
121
ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital
Toledo, Ohio, United States, 43606
Actively Recruiting
122
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
Actively Recruiting
123
Oregon Health and Science University
Portland, Oregon, United States, 97239
Actively Recruiting
124
Lehigh Valley Hospital-Cedar Crest
Allentown, Pennsylvania, United States, 18103
Actively Recruiting
125
Geisinger Medical Center
Danville, Pennsylvania, United States, 17822
Actively Recruiting
126
Penn State Children's Hospital
Hershey, Pennsylvania, United States, 17033
Actively Recruiting
127
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
128
Saint Christopher's Hospital for Children
Philadelphia, Pennsylvania, United States, 19134
Actively Recruiting
129
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, United States, 15224
Actively Recruiting
130
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
Actively Recruiting
131
Prisma Health Richland Hospital
Columbia, South Carolina, United States, 29203
Actively Recruiting
132
BI-LO Charities Children's Cancer Center
Greenville, South Carolina, United States, 29605
Actively Recruiting
133
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota, United States, 57117-5134
Actively Recruiting
134
East Tennessee Childrens Hospital
Knoxville, Tennessee, United States, 37916
Actively Recruiting
135
Saint Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105
Actively Recruiting
136
The Children's Hospital at TriStar Centennial
Nashville, Tennessee, United States, 37203
Actively Recruiting
137
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, United States, 37232
Actively Recruiting
138
Dell Children's Medical Center of Central Texas
Austin, Texas, United States, 78723
Actively Recruiting
139
Driscoll Children's Hospital
Corpus Christi, Texas, United States, 78411
Actively Recruiting
140
Medical City Dallas Hospital
Dallas, Texas, United States, 75230
Actively Recruiting
141
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas, United States, 75390
Actively Recruiting
142
El Paso Children's Hospital
El Paso, Texas, United States, 79905
Actively Recruiting
143
Cook Children's Medical Center
Fort Worth, Texas, United States, 76104
Actively Recruiting
144
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
145
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
146
Covenant Children's Hospital
Lubbock, Texas, United States, 79410
Actively Recruiting
147
UMC Cancer Center / UMC Health System
Lubbock, Texas, United States, 79415
Actively Recruiting
148
Children's Hospital of San Antonio
San Antonio, Texas, United States, 78207
Actively Recruiting
149
Methodist Children's Hospital of South Texas
San Antonio, Texas, United States, 78229
Actively Recruiting
150
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78229
Actively Recruiting
151
Scott and White Memorial Hospital
Temple, Texas, United States, 76508
Actively Recruiting
152
Primary Children's Hospital
Salt Lake City, Utah, United States, 84113
Actively Recruiting
153
University of Virginia Cancer Center
Charlottesville, Virginia, United States, 22908
Actively Recruiting
154
Inova Fairfax Hospital
Falls Church, Virginia, United States, 22042
Actively Recruiting
155
Children's Hospital of The King's Daughters
Norfolk, Virginia, United States, 23507
Actively Recruiting
156
VCU Massey Comprehensive Cancer Center
Richmond, Virginia, United States, 23298
Actively Recruiting
157
Carilion Children's
Roanoke, Virginia, United States, 24014
Actively Recruiting
158
Seattle Children's Hospital
Seattle, Washington, United States, 98105
Actively Recruiting
159
Providence Sacred Heart Medical Center and Children's Hospital
Spokane, Washington, United States, 99204
Actively Recruiting
160
Mary Bridge Children's Hospital and Health Center
Tacoma, Washington, United States, 98405
Actively Recruiting
161
Madigan Army Medical Center
Tacoma, Washington, United States, 98431
Actively Recruiting
162
West Virginia University Charleston Division
Charleston, West Virginia, United States, 25304
Actively Recruiting
163
University of Wisconsin Carbone Cancer Center - University Hospital
Madison, Wisconsin, United States, 53792
Actively Recruiting
164
Marshfield Medical Center-Marshfield
Marshfield, Wisconsin, United States, 54449
Actively Recruiting
165
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
166
Sydney Children's Hospital
Randwick, New South Wales, Australia, 2031
Actively Recruiting
167
The Children's Hospital at Westmead
Westmead, New South Wales, Australia, 2145
Actively Recruiting
168
Perth Children's Hospital
Perth, Western Australia, Australia, 6009
Actively Recruiting
169
Alberta Children's Hospital
Calgary, Alberta, Canada, T3B 6A8
Actively Recruiting
170
University of Alberta Hospital
Edmonton, Alberta, Canada, T6G 2B7
Actively Recruiting
171
British Columbia Children's Hospital
Vancouver, British Columbia, Canada, V6H 3V4
Actively Recruiting
172
CancerCare Manitoba
Winnipeg, Manitoba, Canada, R3E 0V9
Actively Recruiting
173
IWK Health Centre
Halifax, Nova Scotia, Canada, B3K 6R8
Actively Recruiting
174
Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8
Actively Recruiting
175
The Montreal Children's Hospital of the MUHC
Montreal, Quebec, Canada, H3H 1P3
Actively Recruiting
176
Centre Hospitalier Universitaire Sainte-Justine
Montreal, Quebec, Canada, H3T 1C5
Actively Recruiting
177
Centre Hospitalier Universitaire de Sherbrooke-Fleurimont
Sherbrooke, Quebec, Canada, J1H 5N4
Actively Recruiting
178
CHU de Quebec-Centre Hospitalier de l'Universite Laval (CHUL)
Québec, Canada, G1V 4G2
Actively Recruiting
179
Starship Children's Hospital
Grafton, Auckland, New Zealand, 1145
Actively Recruiting
180
Christchurch Hospital
Christchurch, New Zealand, 8011
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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