Taking people in United StatesPhase 3

Chemotherapy for the Treatment of Patients With Newly Diagnosed Very Low-Risk and Low Risk Fusion Negative Rhabdomyosarcoma

Key facts

Where: Akron, Albany, Albuquerque, Allentown, Ann Arbor, Atlanta, Aurora, Austin, Baltimore, Birmingham, Boise, Boston, Buffalo, Chapel Hill, Charleston, Charlotte, Charlottesville, Chicago, Cincinnati, Cleveland, Columbia, Columbus, Corpus Christi, Dallas, Danville, Dayton, Denver, Des Moines, Detroit, Downey, Durham, El Paso, Falls Church, Fargo, Fort Lauderdale, Fort Myers, Fort Worth, Gainesville, Grand Rapids, Greenville, Hackensack, Hartford, Hershey, Hollywood, Honolulu, Houston, Indianapolis, Iowa City, Jackson, Jacksonville, Kalamazoo, Kansas City, Knoxville, Las Vegas, Lebanon, Lexington, Little Rock, Loma Linda, Long Beach, Los Angeles, Louisville, Lubbock, Macon, Madera, Madison, Marshfield, Maywood, Memphis, Miami, Milwaukee, Minneapolis, Mobile, Morristown, Nashville, Neptune City, New Brunswick, New Haven, New Hyde Park, New Orleans, New York, Newark, Norfolk, Oak Lawn, Oakland, Oklahoma City, Omaha, Orange, Orlando, Palo Alto, Park Ridge, Pensacola, Peoria, Philadelphia, Phoenix, Pittsburgh, Portland, Providence, Reno, Richmond, Roanoke, Rochester, Royal Oak, Sacramento, Salt Lake City, San Antonio, San Diego, San Francisco, Savannah, Scarborough, Seattle, Sioux Falls, Spokane, Springfield, St Louis, St. Petersburg, Syracuse, Tacoma, Tampa, Temple, The Bronx, Toledo, Valhalla, Washington D.C., West Palm Beach, Wichita, Wilmington, Winfield, Winston-Salem, and Worcester, United StatesSee the 166 sites
Phase: Phase 3

Where in United States

Children's Hospital Medical Center of AkronAkron, United StatesTaking people
Albany Medical CenterAlbany, United StatesTaking people
University of New Mexico Cancer CenterAlbuquerque, United StatesTaking people
Lehigh Valley Hospital-Cedar CrestAllentown, United StatesTaking people
C S Mott Children's HospitalAnn Arbor, United StatesTaking people
Children's Healthcare of Atlanta - Arthur M Blank HospitalAtlanta, United StatesTaking people
Children's Hospital ColoradoAurora, United StatesTaking people
Dell Children's Medical Center of Central TexasAustin, United StatesTaking people
Johns Hopkins University/Sidney Kimmel Cancer CenterBaltimore, United StatesTaking people
Sinai Hospital of BaltimoreBaltimore, United StatesTaking people
University of Maryland/Greenebaum Cancer CenterBaltimore, United StatesTaking people
Children's Hospital of AlabamaBirmingham, United StatesTaking people
Saint Luke's Cancer Institute - BoiseBoise, United StatesTaking people
Dana-Farber Cancer InstituteBoston, United StatesTaking people
Massachusetts General Hospital Cancer CenterBoston, United StatesTaking people
Roswell Park Cancer InstituteBuffalo, United StatesTaking people
UNC Lineberger Comprehensive Cancer CenterChapel Hill, United StatesTaking people
Medical University of South CarolinaCharleston, United StatesTaking people
West Virginia University Charleston DivisionCharleston, United StatesTaking people
Carolinas Medical Center/Levine Cancer InstituteCharlotte, United StatesTaking people
Novant Health Presbyterian Medical CenterCharlotte, United StatesTaking people
University of Virginia Cancer CenterCharlottesville, United StatesTaking people
Lurie Children's Hospital-ChicagoChicago, United StatesTaking people
University of Chicago Comprehensive Cancer CenterChicago, United StatesTaking people
University of IllinoisChicago, United StatesNo longer taking part
Cincinnati Children's Hospital Medical CenterCincinnati, United StatesTaking people
Cleveland Clinic FoundationCleveland, United StatesTaking people
Rainbow Babies and Childrens HospitalCleveland, United StatesTaking people
Prisma Health Richland HospitalColumbia, United StatesTaking people
Nationwide Children's HospitalColumbus, United StatesTaking people
Driscoll Children's HospitalCorpus Christi, United StatesTaking people
Medical City Dallas HospitalDallas, United StatesTaking people
UT Southwestern/Simmons Cancer Center-DallasDallas, United StatesTaking people
Geisinger Medical CenterDanville, United StatesTaking people
Dayton Children's HospitalDayton, United StatesTaking people
Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical CenterDenver, United StatesTaking people
Blank Children's HospitalDes Moines, United StatesTaking people
Children's Hospital of MichiganDetroit, United StatesTaking people
Kaiser Permanente Downey Medical CenterDowney, United StatesTaking people
Duke University Medical CenterDurham, United StatesTaking people
El Paso Children's HospitalEl Paso, United StatesTaking people
Inova Fairfax HospitalFalls Church, United StatesTaking people
Sanford Broadway Medical CenterFargo, United StatesTaking people
Broward Health Medical CenterFort Lauderdale, United StatesTaking people
Golisano Children's Hospital of Southwest FloridaFort Myers, United StatesTaking people
Cook Children's Medical CenterFort Worth, United StatesTaking people
UF Health Cancer Institute - GainesvilleGainesville, United StatesTaking people
Corewell Health Grand Rapids Hospitals - Helen DeVos Children's HospitalGrand Rapids, United StatesTaking people
BI-LO Charities Children's Cancer CenterGreenville, United StatesTaking people
East Carolina UniversityGreenville, United StatesTaking people
Hackensack University Medical CenterHackensack, United StatesTaking people
Connecticut Children's Medical CenterHartford, United StatesTaking people
Penn State Children's HospitalHershey, United StatesTaking people
Memorial Regional Hospital/Joe DiMaggio Children's HospitalHollywood, United StatesTaking people
Kapiolani Medical Center for Women and ChildrenHonolulu, United StatesTaking people
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer CenterHouston, United StatesTaking people
UT MD Anderson Cancer CenterHouston, United StatesTaking people
Ascension Saint Vincent Indianapolis HospitalIndianapolis, United StatesTaking people
Riley Hospital for ChildrenIndianapolis, United StatesTaking people
University of Iowa/Holden Comprehensive Cancer CenterIowa City, United StatesTaking people
University of Mississippi Medical CenterJackson, United StatesTaking people
Nemours Children's Clinic-JacksonvilleJacksonville, United StatesTaking people
Bronson Methodist HospitalKalamazoo, United StatesTaking people
Children's Mercy Hospitals and ClinicsKansas City, United StatesTaking people
East Tennessee Childrens HospitalKnoxville, United StatesTaking people
Alliance for Childhood Diseases/Cure 4 the Kids FoundationLas Vegas, United StatesTaking people
Summerlin Hospital Medical CenterLas Vegas, United StatesTaking people
Dartmouth Hitchcock Medical Center/Dartmouth Cancer CenterLebanon, United StatesTaking people
University of Kentucky/Markey Cancer CenterLexington, United StatesTaking people
Arkansas Children's HospitalLittle Rock, United StatesTaking people
Loma Linda University Medical CenterLoma Linda, United StatesTaking people
Miller Children's and Women's Hospital Long BeachLong Beach, United StatesTaking people
Cedars-Sinai Medical CenterLos Angeles, United StatesTaking people
Children's Hospital Los AngelesLos Angeles, United StatesTaking people
Mattel Children's Hospital UCLALos Angeles, United StatesTaking people
Norton Children's HospitalLouisville, United StatesTaking people
Covenant Children's HospitalLubbock, United StatesTaking people
UMC Cancer Center / UMC Health SystemLubbock, United StatesTaking people
Atrium Health NavicentMacon, United StatesTaking people
Valley Children's HospitalMadera, United StatesTaking people
University of Wisconsin Carbone Cancer Center - University HospitalMadison, United StatesTaking people
Marshfield Medical Center-MarshfieldMarshfield, United StatesTaking people
Loyola University Medical CenterMaywood, United StatesTaking people
Saint Jude Children's Research HospitalMemphis, United StatesTaking people
Nicklaus Children's HospitalMiami, United StatesTaking people
University of Miami Miller School of Medicine-Sylvester Cancer CenterMiami, United StatesTaking people
Children's Hospital of WisconsinMilwaukee, United StatesTaking people
Children's Hospitals and Clinics of Minnesota - MinneapolisMinneapolis, United StatesTaking people
University of Minnesota/Masonic Cancer CenterMinneapolis, United StatesTaking people
USA Health Strada Patient Care CenterMobile, United StatesTaking people
Morristown Medical CenterMorristown, United StatesTaking people
The Children's Hospital at TriStar CentennialNashville, United StatesTaking people
Vanderbilt University/Ingram Cancer CenterNashville, United StatesTaking people
Jersey Shore Medical CenterNeptune City, United StatesTaking people
Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University HospitalNew Brunswick, United StatesTaking people
Yale UniversityNew Haven, United StatesTaking people
The Steven and Alexandra Cohen Children's Medical Center of New YorkNew Hyde Park, United StatesTaking people
Children's Hospital New OrleansNew Orleans, United StatesTaking people
Ochsner Medical Center JeffersonNew Orleans, United StatesTaking people
Laura and Isaac Perlmutter Cancer Center at NYU LangoneNew York, United StatesTaking people
Memorial Sloan-Kettering Cancer CenterNew York, United StatesTaking people
Mount Sinai HospitalNew York, United StatesTaking people
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer CenterNew York, United StatesTaking people
Newark Beth Israel Medical CenterNewark, United StatesTaking people
Children's Hospital of The King's DaughtersNorfolk, United StatesTaking people
Advocate Children's Hospital-Oak LawnOak Lawn, United StatesTaking people
Kaiser Permanente-OaklandOakland, United StatesTaking people
UCSF Benioff Children's Hospital OaklandOakland, United StatesTaking people
University of Oklahoma Health Sciences CenterOklahoma City, United StatesTaking people
Children's Hospital and Medical Center of OmahaOmaha, United StatesTaking people
University of Nebraska Medical CenterOmaha, United StatesTaking people
Children's Hospital of Orange CountyOrange, United StatesTaking people
AdventHealth OrlandoOrlando, United StatesTaking people
Arnold Palmer Hospital for ChildrenOrlando, United StatesTaking people
Nemours Children's HospitalOrlando, United StatesTaking people
Lucile Packard Children's Hospital Stanford UniversityPalo Alto, United StatesTaking people
Advocate Children's Hospital-Park RidgePark Ridge, United StatesTaking people
Nemours Children's Clinic - PensacolaPensacola, United StatesTaking people
Sacred Heart HospitalPensacola, United StatesNo longer taking part
OSF Children's Hospital of IllinoisPeoria, United StatesTaking people
Children's Hospital of PhiladelphiaPhiladelphia, United StatesTaking people
Saint Christopher's Hospital for ChildrenPhiladelphia, United StatesTaking people
Phoenix Childrens HospitalPhoenix, United StatesTaking people
Children's Hospital of Pittsburgh of UPMCPittsburgh, United StatesTaking people
Oregon Health and Science UniversityPortland, United StatesTaking people
Rhode Island HospitalProvidence, United StatesTaking people
Renown Regional Medical CenterReno, United StatesTaking people
VCU Massey Comprehensive Cancer CenterRichmond, United StatesTaking people
Carilion Children'sRoanoke, United StatesTaking people
Mayo Clinic in RochesterRochester, United StatesTaking people
University of RochesterRochester, United StatesTaking people
Corewell Health Children'sRoyal Oak, United StatesTaking people
University of California Davis Comprehensive Cancer CenterSacramento, United StatesTaking people
Primary Children's HospitalSalt Lake City, United StatesTaking people
Children's Hospital of San AntonioSan Antonio, United StatesTaking people
Methodist Children's Hospital of South TexasSan Antonio, United StatesTaking people
University of Texas Health Science Center at San AntonioSan Antonio, United StatesTaking people
Naval Medical Center -San DiegoSan Diego, United StatesTaking people
Rady Children's Hospital - San DiegoSan Diego, United StatesTaking people
UCSF Medical Center-Mission BaySan Francisco, United StatesTaking people
Memorial Health University Medical CenterSavannah, United StatesTaking people
Maine Children's Cancer ProgramScarborough, United StatesTaking people
Seattle Children's HospitalSeattle, United StatesTaking people
Sanford USD Medical Center - Sioux FallsSioux Falls, United StatesTaking people
Providence Sacred Heart Medical Center and Children's HospitalSpokane, United StatesTaking people
Southern Illinois University School of MedicineSpringfield, United StatesTaking people
Cardinal Glennon Children's Medical CenterSt Louis, United StatesTaking people
Mercy Hospital Saint LouisSt Louis, United StatesTaking people
Washington University School of MedicineSt Louis, United StatesTaking people
Johns Hopkins All Children's HospitalSt. Petersburg, United StatesTaking people
State University of New York Upstate Medical UniversitySyracuse, United StatesTaking people
Madigan Army Medical CenterTacoma, United StatesTaking people
Mary Bridge Children's Hospital and Health CenterTacoma, United StatesTaking people
Saint Joseph's Hospital/Children's Hospital-TampaTampa, United StatesTaking people
Scott and White Memorial HospitalTemple, United StatesTaking people
Montefiore Medical Center - Moses CampusThe Bronx, United StatesTaking people
ProMedica Toledo Hospital/Russell J Ebeid Children's HospitalToledo, United StatesTaking people
New York Medical CollegeValhalla, United StatesTaking people
Children's National Medical CenterWashington D.C., United StatesTaking people
MedStar Georgetown University HospitalWashington D.C., United StatesTaking people
Saint Mary's Medical CenterWest Palm Beach, United StatesTaking people
Wesley Medical CenterWichita, United StatesTaking people
Alfred I duPont Hospital for ChildrenWilmington, United StatesTaking people
Northwestern Medicine Central DuPage HospitalWinfield, United StatesTaking people
Wake Forest University Health SciencesWinston-Salem, United StatesTaking people
UMass Memorial Medical Center - University CampusWorcester, United StatesTaking people

Questions to ask the study team

How often do I need to come in, and for how long each time?
Are travel costs paid?
Can I keep my own doctor?
What happens if I want to stop?

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Trial details

Who runs it: Children's Oncology Group
Trial code: NCT05304585
Record updated: 25 August 2026
Original description: Rhabdomyosarcoma is a type of cancer that occurs in the soft tissues in the body. This phase III trial aims to maintain excellent outcomes in patients with very low risk rhabdomyosarcoma (VLR-RMS) while decreasing the burden of therapy using treatment with 24 weeks of vincristine and dactinomycin (VA) and examines the use of centralized molecular risk stratification in the treatment of rhabdomyosarcoma. Another aim of the study it to find out how well patients with low risk rhabdomyosarcoma (LR-RMS) respond to standard chemotherapy when patients with VLR-RMS and patients who have rhabdomyosarcoma with DNA mutations get separate treatment. Finally, this study examines the effect of therapy intensification in patients who have RMS cancer with DNA mutations to see if their outcomes can be improved.Read full original descriptionShow less
A Prospective Phase 3 Study of Patients With Newly Diagnosed Very Low-Risk and Low-Risk Fusion Negative Rhabdomyosarcoma
Rhabdomyosarcoma is a type of cancer that occurs in the soft tissues in the body. This phase III trial aims to maintain excellent outcomes in patients with very low risk rhabdomyosarcoma (VLR-RMS) while decreasing the burden of therapy using treatment with 24 weeks of vincristine and dactinomycin (VA) and examines the use of centralized molecular risk stratification in the treatment of rhabdomyosarcoma. Another aim of the study it to find out how well patients with low risk rhabdomyosarcoma (LR-RMS) respond to standard chemotherapy when patients with VLR-RMS and patients who have rhabdomyosarcoma with DNA mutations get separate treatment. Finally, this study examines the effect of therapy intensification in patients who have RMS cancer with DNA mutations to see if their outcomes can be improved.
Inclusion: All patients must be enrolled on APEC14B1 (NCT02402244) and consented to the Molecular Characterization Initiative (Part A) prior to enrollment and treatment on ARST2032 (this trial); Patients must be =< 21 years at the time of enrollment; Patients must have newly diagnosed embryonal rhabdomyosarcoma (ERMS), spindle cell/sclerosing RMS, or FOXO1 fusion negative alveolar rhabdomyosarcoma (ARMS) (institutional FOXO1 fusion results are acceptable). RMS types included under ERMS include those classified in the 1995 International Classification of Rhabdomyosarcoma (ICR) as ERMS (classic, spindle cell, and botryoid variants), which are reclassified in the 2020 World Health Organization (WHO) classification as ERMS (classic, dense and botryoid variants) and spindle cell/sclerosing RMS (encompassing the historical spindle cell ERMS variant and the newly recognized sclerosing RMS variant). Enrollment in APEC14B1 is required for all patients; All patients will be evaluated for stage and clinical group. Note that clinical group designation assigned at the time of enrollment on study remains unchanged regardless of any second-look operation that may be performed; Patients will be eligible for the very low-risk stratum (Regimen VA) if they have Stage 1, CG I disease; Patients will be eligible for the low-risk stratum (Regimen VAC/VA) if they have Stage 1, CG II disease, Stage 2, CG I or II disease, or Stage 1, CG III (orbit only) disease; Paratesticular Tumors: Staging ipsilateral retroperitoneal lymph node sampling (SIRLNS) is required for all patients >= 10 years of age with paratesticular tumors who do not have gross nodal involvement on imaging; Extremity Tumors: Regional lymph node sampling is required for histologic evaluation in patients with extremity tumors; Clinically or radiographically enlarged nodes must be sampled for histologic evaluation; Patients must have a Lansky (for patients =< 16 years of age) or Karnofsky (for patients > 16 years of age) performance status score of >= 50. Patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing performance score; Peripheral absolute neutrophil count (ANC) >= 750/uL (within 7 days prior to enrollment); Platelet count >= 75,000/uL (transfusion independent) (within 7 days prior to enrollment); Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 mL/min/1.73 m\^2 or a serum creatinine (within 7 days prior to enrollment) based on age/gender as follows:; Age: 1 month to < 6 months; Maximum serum creatinine (mg/dL): 0.4 (male) : 0.4 (female); Age: 6 months to < 1 year; Maximum serum creatinine (mg/dL): 0.5 (male) : 0.5 (female); Age: 1 to < 2 years; Maximum serum creatinine (mg/dL): 0.6 (male) : 0.6 (female); Age: 2 to < 6 years; Maximum serum creatinine (mg/dL): 0.8 (male) : 0.8 (female); Age: 6 to < 10 years; Maximum serum creatinine (mg/dL): 1 (male) : 1 (female); Age: 10 to < 13 years; Maximum serum creatinine (mg/dL): 1.2 (male) : 1.2 (female); Age: 13 to < 16 years; Maximum serum creatinine (mg/dL): 1.5 (male) : 1.4 (female); Age >= 16 years; Maximum serum creatinine (mg/dL): 1.7 (male) : 1.4 (female); Total bilirubin =< 1.5 x upper limit of normal (ULN) for age (within 7 days prior to enrollment), and; If there is evidence of biliary obstruction by the tumor, then the total bilirubin must be < 3 x ULN for age; Note: For the purpose of this study, the ULN for SGPT (ALT) has been set to the value of 45 U/L; Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) =< 135 U/L; If there is evidence of biliary obstruction by the tumor, then the total bilirubin must be < 3 x ULN for age; Note: For the purpose of this study, the ULN for SGPT (ALT) has been set to the value of 45 U/L; All patients and/or their parents or legal guardians must sign a written informed consent; All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met.
Exclusion: Patients who have received chemotherapy or radiation for non-malignant conditions (e.g., autoimmune diseases) are eligible. Patients must discontinue chemotherapy for non-malignant conditions prior to starting protocol therapy; Vincristine is sensitive substrate of the CYP450 3A4 isozyme. Patients must not have received drugs that are moderate to strong CYP3A4 inhibitors and inducers within 7 days prior to study enrollment; Patients unable to undergo radiation therapy, if necessary, as specified in the protocol; Female patients who are pregnant since fetal toxicities and teratogenic effects have been noted for several of the study drugs. A pregnancy test is required for female patients of childbearing potential; Patients who have received prior chemotherapy and/or radiation therapy for cancer prior to enrollment. Surgical resection alone of previous cancer(s) is permitted; Evidence of uncontrolled infection; Lactating females who plan to breastfeed their infants; Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participation.
ClinicalTrials.gov NCT05304585