Combination Chemotherapy With or Without Temsirolimus in Treating Patients With Intermediate Risk Rhabdomyosarcoma
A Randomized Phase 3 Study of Vincristine, Dactinomycin, Cyclophosphamide (VAC) Alternating With Vincristine and Irinotecan (VI) Versus VAC/VI Plus Temsirolimus (TORI, Torisel, NSC# 683864) in Patients With Intermediate Risk (IR) Rhabdomyosarcoma (RMS)
3 other identifiers
interventional
325
5 countries
383
Brief Summary
This randomized phase III trial studies how well combination chemotherapy (vincristine sulfate, dactinomycin, cyclophosphamide alternated with vincristine sulfate and irinotecan hydrochloride or vinorelbine) works compared to combination chemotherapy plus temsirolimus in treating patients with rhabdomyosarcoma (cancer that forms in the soft tissues, such as muscle), and has an intermediate chance of coming back after treatment (intermediate risk). Drugs used 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. Combination chemotherapy and temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether chemotherapy plus temsirolimus is more effective than chemotherapy alone in treating patients with intermediate-risk rhabdomyosarcoma.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jun 2016
Longer than P75 for phase_3
383 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 2, 2015
CompletedFirst Posted
Study publicly available on registry
October 5, 2015
CompletedStudy Start
First participant enrolled
June 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2023
CompletedResults Posted
Study results publicly available
October 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
October 27, 2026
ExpectedMay 1, 2026
April 1, 2026
7.1 years
October 2, 2015
July 1, 2024
April 30, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Event-free Survival (EFS)
The Kaplan-Meier method will used to estimate 3-year EFS between the randomized treatment groups (Regimen A (VAC/VI) vs. Regimen B (VAC/VI/Temsirolimus)) using the log-rank test. EFS event is defined as the time from study entry until first occurrence of progression, relapse, second malignancy, or death.
Up to 3 years from study entry
Secondary Outcomes (1)
Overall Survival (OS)
Up to 3 years from study entry
Other Outcomes (4)
Frequency of Circulating Tumor DNA (ctDNA) at Diagnosis and Subsequent Time-points
Up to 10 years
Patient Outcome Based on Their Forkhead Box O1 Protein (FOXO1) Partner, by Evaluating PAX3 vs. PAX7 in All Patients Found to be FOXO1 Fusion Positive
Up to 10 years
Patient Outcome Based on Their [F18]-Fluorodeoxy-D-glucose-positron Emission Tomography (FDG-positron Emission Tomography [PET]) Response
At week 9
- +1 more other outcomes
Study Arms (3)
Regimen A (VAC/VI)
EXPERIMENTALPatients receive vincristine sulfate IV over 1 minute on day 1 of weeks 1-13, 16, 17, 19, 20, 22-26, 28, 31-34, 37, 38, and 40, dactinomycin IV over 1-5 or 10-15 minutes on day 1 of weeks 1, 7, 13, 22, 28, 34, and 40, cyclophosphamide IV over 60 minutes on day 1 of weeks 1, 7, 13, 22, 28, 34, and 40, irinotecan hydrochloride IV over 90 minutes on days 1-5 of weeks 4, 10, 16, 19, 25, 31, and 37. Patients also undergo primary site RT beginning at week 13 or metastatic site RT beginning at week 43 for up to 6.5 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients then receive vinorelbine IV over 6-10 minutes on days 1, 8, and 15 and cyclophosphamide PO QD on days 1-28. Cycles repeats every 28 days for 24 weeks in the absence of disease progression or unacceptable toxicity.
Regimen B (VAC/VI/temsirolimus)
EXPERIMENTALPatients receive vincristine sulfate IV over 1 minute on day 1 of weeks 1-13, 16, 17, 19, 20, 22-26, 28, 31-34, 37, 38, and 40, dactinomycin IV over 1-5 or 10-15 minutes on day 1 of weeks 1, 7, 13, 22, 28, 34, and 40, cyclophosphamide IV over 60 minutes on day 1 of weeks 1, 7, 13, 22, 28, 34, and 40, irinotecan hydrochloride IV over 90 minutes on days 1-5 of weeks 4, 10, 16, 19, 25, 31, and 37 and temsirolimus IV over 30-60 minutes on day 1 of weeks 1-12 and 21-42. Patients also undergo RT as in Regimen A. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients then receive vinorelbine IV over 6-10 minutes on days 1, 8, and 15 and cyclophosphamide PO QD on days 1-28. Cycles repeats every 28 days for 24 weeks in the absence of disease progression or unacceptable toxicity.
Regimen C (FOXO1 fusion negative, VAC/VA)
EXPERIMENTALPatients receive vincristine sulfate IV over 1 minute on day 1 of weeks 1-10 and 13-22, dactinomycin IV over 1-5 or 10-15 minutes on day 1 of weeks 1, 4, 7, 10, 13, 16, 19, and 22, cyclophosphamide IV over 60 minutes on day 1 of weeks 1, 4, 7, and 10. Patients undergo RT beginning at week 13 for up to 6.5 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.
Interventions
Given IV
Given IV and PO
Given IV
Correlative studies
Ancillary studies
Undergo RT
Given IV
Given IV
Given IV
Eligibility Criteria
You may qualify if:
- Feasibility Phase: Patients must be \< 21 years of age at the time of enrollment; please note: the feasibility phase is complete, effective with amendment #1
- Efficacy Phase: Patients must be =\< 40 years of age at the time of enrollment
- Patients with newly diagnosed RMS of any subtype, except adult-type pleomorphic, based upon institutional histopathologic classification, are eligible to enroll on the study based upon stage, group, and age, as below
- RMS types included under embryonal rhabdomyosarcoma (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 2013 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); classification of alveolar rhabdomyosarcoma (ARMS) in the 2013 WHO classification is the same as in the ICR and includes classic and solid variants
- ERMS
- Stage 1, group III (non-orbit)
- Stage 3, group I/II
- Stage 2/3, group III
- Stage 4, group IV, \< 10 years old
- ARMS:
- Stages 1-3, groups I-III
- Specimen Submission: Patients must have sufficient tissue available for the required biology study
- Lansky performance status score \>= 50 for patients =\< 16 years of age; Karnofsky performance status score \>= 50 for patients \> 16 years of age
- Peripheral absolute neutrophil count (ANC) \>= 750/uL
- Platelet count \>= 75,000/uL
- +13 more criteria
You may not qualify if:
- Patients who have previously received temsirolimus, another mTOR inhibitor, or any other investigational agent
- Patients who have received any chemotherapy (excluding steroids) and/or RT prior to this enrollment
- Patients with uncontrolled hyperglycemia
- Patients with uncontrolled hyperlipidemia
- Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participation and for at least 3 months after treatment is completed
- Female patients who are pregnant are not eligible since fetal toxicities or teratogenic effects have been noted for several of the study drugs; Note: A pregnancy test is required for female patients of childbearing potential prior to study entry
- Lactating females who plan to breastfeed their infants are not eligible
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (383)
Children's Hospital of Alabama
Birmingham, Alabama, 35233, United States
USA Health Strada Patient Care Center
Mobile, Alabama, 36604, United States
Anchorage Associates in Radiation Medicine
Anchorage, Alaska, 98508, United States
Anchorage Radiation Therapy Center
Anchorage, Alaska, 99504, United States
Alaska Breast Care and Surgery LLC
Anchorage, Alaska, 99508, United States
Alaska Oncology and Hematology LLC
Anchorage, Alaska, 99508, United States
Alaska Women's Cancer Care
Anchorage, Alaska, 99508, United States
Anchorage Oncology Centre
Anchorage, Alaska, 99508, United States
Katmai Oncology Group
Anchorage, Alaska, 99508, United States
Providence Alaska Medical Center
Anchorage, Alaska, 99508, United States
Kingman Regional Medical Center
Kingman, Arizona, 86401, United States
Banner Children's at Desert
Mesa, Arizona, 85202, United States
Phoenix Childrens Hospital
Phoenix, Arizona, 85016, United States
Mayo Clinic Hospital in Arizona
Phoenix, Arizona, 85054, United States
Mayo Clinic in Arizona
Scottsdale, Arizona, 85259, United States
Banner University Medical Center - Tucson
Tucson, Arizona, 85719, United States
Arkansas Children's Hospital
Little Rock, Arkansas, 72202-3591, United States
Kaiser Permanente-Anaheim
Anaheim, California, 92806, United States
PCR Oncology
Arroyo Grande, California, 93420, United States
Kaiser Permanente-Bellflower
Bellflower, California, 90706, United States
Providence Saint Joseph Medical Center/Disney Family Cancer Center
Burbank, California, 91505, United States
Kaiser Permanente Downey Medical Center
Downey, California, 90242, United States
Kaiser Permanente-Fontana
Fontana, California, 92335, United States
Loma Linda University Medical Center
Loma Linda, California, 92354, United States
Children's Hospital Los Angeles
Los Angeles, California, 90027, United States
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, 90027, United States
Mattel Children's Hospital UCLA
Los Angeles, California, 90095, United States
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, 90095, United States
Valley Children's Hospital
Madera, California, 93636, United States
UCSF Benioff Children's Hospital Oakland
Oakland, California, 94609, United States
Kaiser Permanente-Oakland
Oakland, California, 94611, United States
Children's Hospital of Orange County
Orange, California, 92868, United States
Lucile Packard Children's Hospital Stanford University
Palo Alto, California, 94304, United States
Kaiser Permanente-Roseville
Roseville, California, 95661, United States
Sutter Medical Center Sacramento
Sacramento, California, 95816, United States
University of California Davis Comprehensive Cancer Center
Sacramento, California, 95817, United States
Kaiser Permanente-San Diego Mission
San Diego, California, 92108, United States
Rady Children's Hospital - San Diego
San Diego, California, 92123, United States
Naval Medical Center -San Diego
San Diego, California, 92134, United States
UCSF Medical Center-Mission Bay
San Francisco, California, 94158, United States
Kaiser Permanente Medical Center - Santa Clara
Santa Clara, California, 95051, United States
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Torrance, California, 90502, United States
Children's Hospital Colorado
Aurora, Colorado, 80045, United States
Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center
Denver, Colorado, 80218, United States
Connecticut Children's Medical Center
Hartford, Connecticut, 06106, United States
Smilow Cancer Center/Yale-New Haven Hospital
New Haven, Connecticut, 06510, United States
Yale University
New Haven, Connecticut, 06520, United States
Smilow Cancer Hospital Care Center-Trumbull
Trumbull, Connecticut, 06611, United States
Alfred I duPont Hospital for Children
Wilmington, Delaware, 19803, United States
Kaiser Permanente-Capitol Hill Medical Center
Washington D.C., District of Columbia, 20002, United States
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, 20007, United States
Children's National Medical Center
Washington D.C., District of Columbia, 20010, United States
Sibley Memorial Hospital
Washington D.C., District of Columbia, 20016, United States
Broward Health Medical Center
Fort Lauderdale, Florida, 33316, United States
Golisano Children's Hospital of Southwest Florida
Fort Myers, Florida, 33908, United States
UF Health Cancer Institute - Gainesville
Gainesville, Florida, 32610, United States
Memorial Regional Hospital/Joe DiMaggio Children's Hospital
Hollywood, Florida, 33021, United States
Nemours Children's Clinic-Jacksonville
Jacksonville, Florida, 32207, United States
Palms West Radiation Therapy
Loxahatchee Groves, Florida, 33470, United States
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, 33136, United States
Nicklaus Children's Hospital
Miami, Florida, 33155, United States
Miami Cancer Institute
Miami, Florida, 33176, United States
AdventHealth Orlando
Orlando, Florida, 32803, United States
Arnold Palmer Hospital for Children
Orlando, Florida, 32806, United States
Nemours Children's Hospital
Orlando, Florida, 32827, United States
Nemours Children's Clinic - Pensacola
Pensacola, Florida, 32504, United States
Sacred Heart Hospital
Pensacola, Florida, 32504, United States
Johns Hopkins All Children's Hospital
St. Petersburg, Florida, 33701, United States
Tampa General Hospital
Tampa, Florida, 33606, United States
Saint Joseph's Hospital/Children's Hospital-Tampa
Tampa, Florida, 33607, United States
Saint Mary's Medical Center
West Palm Beach, Florida, 33407, United States
Children's Healthcare of Atlanta - Arthur M Blank Hospital
Atlanta, Georgia, 30329, United States
Augusta University Medical Center
Augusta, Georgia, 30912, United States
Atrium Health Navicent
Macon, Georgia, 31201, United States
Memorial Health University Medical Center
Savannah, Georgia, 31404, United States
Straub Clinic and Hospital
Honolulu, Hawaii, 96813, United States
Kaiser Permanente Moanalua Medical Center
Honolulu, Hawaii, 96819, United States
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, 96826, United States
Saint Luke's Cancer Institute - Boise
Boise, Idaho, 83712, United States
Saint Luke's Cancer Institute - Fruitland
Fruitland, Idaho, 83619, United States
Saint Luke's Cancer Institute - Meridian
Meridian, Idaho, 83642, United States
Saint Luke's Cancer Institute - Nampa
Nampa, Idaho, 83687, United States
Saint Luke's Cancer Institute - Twin Falls
Twin Falls, Idaho, 83301, United States
Lurie Children's Hospital-Chicago
Chicago, Illinois, 60611, United States
John H Stroger Jr Hospital of Cook County
Chicago, Illinois, 60612, United States
Rush MD Anderson Cancer Center
Chicago, Illinois, 60612, United States
University of Illinois
Chicago, Illinois, 60612, United States
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, 60637, United States
Loyola University Medical Center
Maywood, Illinois, 60153, United States
Advocate Children's Hospital-Oak Lawn
Oak Lawn, Illinois, 60453, United States
Advocate Children's Hospital-Park Ridge
Park Ridge, Illinois, 60068, United States
Saint Jude Midwest Affiliate
Peoria, Illinois, 61637, United States
Saint John's Hospital
Springfield, Illinois, 62702, United States
Southern Illinois University School of Medicine
Springfield, Illinois, 62702, United States
Springfield Memorial Hospital
Springfield, Illinois, 62781, United States
Riley Hospital for Children
Indianapolis, Indiana, 46202, United States
Ascension Saint Vincent Indianapolis Hospital
Indianapolis, Indiana, 46260, United States
Blank Children's Hospital
Des Moines, Iowa, 50309, United States
Iowa Methodist Medical Center
Des Moines, Iowa, 50309, United States
Iowa Lutheran Hospital
Des Moines, Iowa, 50316, United States
University of Iowa/Holden Comprehensive Cancer Center
Iowa City, Iowa, 52242, United States
University of Kentucky/Markey Cancer Center
Lexington, Kentucky, 40536, United States
Norton Children's Hospital
Louisville, Kentucky, 40202, United States
Children's Hospital New Orleans
New Orleans, Louisiana, 70118, United States
Ochsner Medical Center Jefferson
New Orleans, Louisiana, 70121, United States
Eastern Maine Medical Center
Bangor, Maine, 04401, United States
Maine Children's Cancer Program
Scarborough, Maine, 04074, United States
University of Maryland/Greenebaum Cancer Center
Baltimore, Maryland, 21201, United States
Sinai Hospital of Baltimore
Baltimore, Maryland, 21215, United States
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland, 21287, United States
Walter Reed National Military Medical Center
Bethesda, Maryland, 20889-5600, United States
Tufts Children's Hospital
Boston, Massachusetts, 02111, United States
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215, United States
UMass Memorial Medical Center - University Campus
Worcester, Massachusetts, 01655, United States
C S Mott Children's Hospital
Ann Arbor, Michigan, 48109, United States
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, 48109, United States
Bronson Battle Creek
Battle Creek, Michigan, 49017, United States
Wayne State University/Karmanos Cancer Institute
Detroit, Michigan, 48201, United States
Henry Ford Health Saint John Hospital
Detroit, Michigan, 48236, United States
Michigan State University
East Lansing, Michigan, 48823, United States
Hurley Medical Center
Flint, Michigan, 48503, United States
Corewell Health Grand Rapids Hospitals - Butterworth Hospital
Grand Rapids, Michigan, 49503, United States
Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital
Grand Rapids, Michigan, 49503, United States
Trinity Health Grand Rapids Hospital
Grand Rapids, Michigan, 49503, United States
Bronson Methodist Hospital
Kalamazoo, Michigan, 49007, United States
West Michigan Cancer Center
Kalamazoo, Michigan, 49007, United States
Beacon Kalamazoo
Kalamazoo, Michigan, 49048, United States
University of Michigan Health - Sparrow Lansing
Lansing, Michigan, 48912, United States
Trinity Health Muskegon Hospital
Muskegon, Michigan, 49444, United States
Corewell Health Lakeland Hospitals - Niles Hospital
Niles, Michigan, 49120, United States
Huron Medical Center PC
Port Huron, Michigan, 48060, United States
Lake Huron Medical Center
Port Huron, Michigan, 48060, United States
Corewell Health Reed City Hospital
Reed City, Michigan, 49677, United States
Corewell Health Children's
Royal Oak, Michigan, 48073, United States
Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center
Saint Joseph, Michigan, 49085, United States
Corewell Health Lakeland Hospitals - Saint Joseph Hospital
Saint Joseph, Michigan, 49085, United States
Munson Medical Center
Traverse City, Michigan, 49684, United States
University of Michigan Health - West
Wyoming, Michigan, 49519, United States
Essentia Health Cancer Center
Duluth, Minnesota, 55805, United States
Children's Hospitals and Clinics of Minnesota - Minneapolis
Minneapolis, Minnesota, 55404, United States
University of Minnesota/Masonic Cancer Center
Minneapolis, Minnesota, 55455, United States
Mayo Clinic in Rochester
Rochester, Minnesota, 55905, United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216, United States
Siteman Cancer Center at Saint Peters Hospital
City of Saint Peters, Missouri, 63376, United States
University of Missouri Children's Hospital
Columbia, Missouri, 65212, United States
Siteman Cancer Center at West County Hospital
Creve Coeur, Missouri, 63141, United States
Children's Mercy Hospitals and Clinics
Kansas City, Missouri, 64108, United States
Cardinal Glennon Children's Medical Center
St Louis, Missouri, 63104, United States
Barnes-Jewish Hospital
St Louis, Missouri, 63110, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Mercy Hospital Saint Louis
St Louis, Missouri, 63141, United States
Saint Patrick Hospital - Community Hospital
Missoula, Montana, 59802, United States
Children's Hospital and Medical Center of Omaha
Omaha, Nebraska, 68114, United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198, United States
Carson Tahoe Regional Medical Center
Carson City, Nevada, 89703, United States
Cancer and Blood Specialists-Henderson
Henderson, Nevada, 89052, United States
Comprehensive Cancer Centers of Nevada - Henderson
Henderson, Nevada, 89052, United States
Comprehensive Cancer Centers of Nevada-Horizon Ridge
Henderson, Nevada, 89052, United States
Las Vegas Cancer Center-Henderson
Henderson, Nevada, 89052, United States
Comprehensive Cancer Centers of Nevada-Southeast Henderson
Henderson, Nevada, 89074, United States
Las Vegas Urology - Green Valley
Henderson, Nevada, 89074, United States
Las Vegas Urology - Pebble
Henderson, Nevada, 89074, United States
Oncology Las Vegas - Henderson
Henderson, Nevada, 89074, United States
Urology Specialists of Nevada - Green Valley
Henderson, Nevada, 89074, United States
Las Vegas Urology - Pecos
Las Vegas, Nevada, 89074, United States
Desert West Surgery
Las Vegas, Nevada, 89102, United States
OptumCare Cancer Care at Charleston
Las Vegas, Nevada, 89102, United States
University Medical Center of Southern Nevada
Las Vegas, Nevada, 89102, United States
Cancer and Blood Specialists-Shadow
Las Vegas, Nevada, 89106, United States
Radiation Oncology Centers of Nevada Central
Las Vegas, Nevada, 89106, United States
Urology Specialists of Nevada - Central
Las Vegas, Nevada, 89106, United States
HealthCare Partners Medical Group Oncology/Hematology-Maryland Parkway
Las Vegas, Nevada, 89109, United States
Sunrise Hospital and Medical Center
Las Vegas, Nevada, 89109, United States
HealthCare Partners Medical Group Oncology/Hematology-San Martin
Las Vegas, Nevada, 89113, United States
Las Vegas Urology - Sunset
Las Vegas, Nevada, 89113, United States
Urology Specialists of Nevada - Southwest
Las Vegas, Nevada, 89113, United States
Radiation Oncology Centers of Nevada Southeast
Las Vegas, Nevada, 89119, United States
Cancer Therapy and Integrative Medicine
Las Vegas, Nevada, 89121, United States
Ann M Wierman MD LTD
Las Vegas, Nevada, 89128, United States
Cancer and Blood Specialists-Tenaya
Las Vegas, Nevada, 89128, United States
Comprehensive Cancer Centers of Nevada - Northwest
Las Vegas, Nevada, 89128, United States
HealthCare Partners Medical Group Oncology/Hematology-Tenaya
Las Vegas, Nevada, 89128, United States
Las Vegas Urology - Cathedral Rock
Las Vegas, Nevada, 89128, United States
Las Vegas Urology - Smoke Ranch
Las Vegas, Nevada, 89128, United States
Oncology Las Vegas - Tenaya
Las Vegas, Nevada, 89128, United States
OptumCare Cancer Care at MountainView
Las Vegas, Nevada, 89128, United States
Urology Specialists of Nevada - Northwest
Las Vegas, Nevada, 89128, United States
Alliance for Childhood Diseases/Cure 4 the Kids Foundation
Las Vegas, Nevada, 89135, United States
Comprehensive Cancer Centers of Nevada - Town Center
Las Vegas, Nevada, 89144, United States
Comprehensive Cancer Centers of Nevada-Summerlin
Las Vegas, Nevada, 89144, United States
Summerlin Hospital Medical Center
Las Vegas, Nevada, 89144, United States
Las Vegas Cancer Center-Medical Center
Las Vegas, Nevada, 89148-2405, United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, 89148, United States
HealthCare Partners Medical Group Oncology/Hematology-Centennial Hills
Las Vegas, Nevada, 89149, United States
Comprehensive Cancer Centers of Nevada - Central Valley
Las Vegas, Nevada, 89169, United States
University Cancer Center
Las Vegas, Nevada, 89169, United States
OptumCare Cancer Care at Fort Apache
Las Vegas, Nevada, 89183, United States
Hope Cancer Care of Nevada-Pahrump
Pahrump, Nevada, 89048, United States
Renown Regional Medical Center
Reno, Nevada, 89502, United States
Saint Mary's Regional Medical Center
Reno, Nevada, 89503, United States
Radiation Oncology Associates
Reno, Nevada, 89509, United States
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
Lebanon, New Hampshire, 03756, United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
Morristown Medical Center
Morristown, New Jersey, 07960, United States
Saint Peter's University Hospital
New Brunswick, New Jersey, 08901, United States
Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital
New Brunswick, New Jersey, 08903, United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903, United States
Newark Beth Israel Medical Center
Newark, New Jersey, 07112, United States
Saint Joseph's Regional Medical Center
Paterson, New Jersey, 07503, United States
Presbyterian Hospital
Albuquerque, New Mexico, 87106, United States
Albany Medical Center
Albany, New York, 12208, United States
Maimonides Medical Center
Brooklyn, New York, 11219, United States
Roswell Park Cancer Institute
Buffalo, New York, 14263, United States
Glens Falls Hospital
Glens Falls, New York, 12801, United States
NYU Langone Hospital - Long Island
Mineola, New York, 11501, United States
The Steven and Alexandra Cohen Children's Medical Center of New York
New Hyde Park, New York, 11040, United States
Laura and Isaac Perlmutter Cancer Center at NYU Langone
New York, New York, 10016, United States
Mount Sinai Hospital
New York, New York, 10029, United States
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
New York, New York, 10032, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
University of Rochester
Rochester, New York, 14642, United States
Stony Brook University Medical Center
Stony Brook, New York, 11794, United States
State University of New York Upstate Medical University
Syracuse, New York, 13210, United States
Montefiore Medical Center-Einstein Campus
The Bronx, New York, 10461, United States
Montefiore Medical Center-Weiler Hospital
The Bronx, New York, 10461, United States
Children's Hospital at Montefiore
The Bronx, New York, 10467, United States
Montefiore Medical Center - Moses Campus
The Bronx, New York, 10467, United States
New York Medical College
Valhalla, New York, 10595, United States
Westchester Medical Center
Valhalla, New York, 10595, United States
Mission Hospital
Asheville, North Carolina, 28801, United States
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27599, United States
Carolinas Medical Center/Levine Cancer Institute
Charlotte, North Carolina, 28203, United States
Novant Health Presbyterian Medical Center
Charlotte, North Carolina, 28204, United States
Novant Health Carolina Surgical - Randolph
Charlotte, North Carolina, 28207, United States
Oncology Specialists of Charlotte
Charlotte, North Carolina, 28207, United States
Southern Oncology Specialists-Charlotte
Charlotte, North Carolina, 28262, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
East Carolina University
Greenville, North Carolina, 27834, United States
Novant Health Cancer Institute - Huntersville
Huntersville, North Carolina, 28078, United States
Novant Health Presbyterian Medical Center Huntersville
Huntersville, North Carolina, 28078, United States
Southern Oncology Specialists-Huntersville
Huntersville, North Carolina, 28078, United States
Matthews Radiation Oncology Center
Matthews, North Carolina, 28105, United States
Novant Health Cancer Institute - Matthews
Matthews, North Carolina, 28105, United States
Novant Health Cancer Institute - Mooresville
Mooresville, North Carolina, 28117, United States
Novant Health Cancer Institute - Rowan
Salisbury, North Carolina, 28144, United States
Rowan Regional Medical Center
Salisbury, North Carolina, 28144, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157, United States
Sanford Broadway Medical Center
Fargo, North Dakota, 58122, United States
Children's Hospital Medical Center of Akron
Akron, Ohio, 44308, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229, United States
Rainbow Babies and Childrens Hospital
Cleveland, Ohio, 44106, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Nationwide Children's Hospital
Columbus, Ohio, 43205, United States
Dayton Children's Hospital
Dayton, Ohio, 45404, United States
ProMedica Flower Hospital
Sylvania, Ohio, 43560, United States
ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital
Toledo, Ohio, 43606, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104, United States
Saint Charles Health System
Bend, Oregon, 97701, United States
Clackamas Radiation Oncology Center
Clackamas, Oregon, 97015, United States
Providence Cancer Institute Clackamas Clinic
Clackamas, Oregon, 97015, United States
Bay Area Hospital
Coos Bay, Oregon, 97420, United States
Providence Newberg Medical Center
Newberg, Oregon, 97132, United States
Providence Portland Medical Center
Portland, Oregon, 97213, United States
Providence Saint Vincent Medical Center
Portland, Oregon, 97225, United States
Legacy Emanuel Children's Hospital
Portland, Oregon, 97227, United States
Oregon Health and Science University
Portland, Oregon, 97239, United States
Lehigh Valley Hospital-Cedar Crest
Allentown, Pennsylvania, 18103, United States
Lehigh Valley Hospital - Muhlenberg
Bethlehem, Pennsylvania, 18017, United States
Geisinger Medical Center
Danville, Pennsylvania, 17822, United States
Penn State Children's Hospital
Hershey, Pennsylvania, 17033, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
Saint Christopher's Hospital for Children
Philadelphia, Pennsylvania, 19134, United States
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, 15224, United States
Rhode Island Hospital
Providence, Rhode Island, 02903, United States
Prisma Health Cancer Institute - Spartanburg
Boiling Springs, South Carolina, 29316, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Prisma Health Cancer Institute - Laurens
Clinton, South Carolina, 29325, United States
Prisma Health Richland Hospital
Columbia, South Carolina, 29203, United States
Prisma Health Cancer Institute - Easley
Easley, South Carolina, 29640, United States
Saint Francis Hospital
Greenville, South Carolina, 29601, United States
BI-LO Charities Children's Cancer Center
Greenville, South Carolina, 29605, United States
Prisma Health Cancer Institute - Butternut
Greenville, South Carolina, 29605, United States
Prisma Health Cancer Institute - Faris
Greenville, South Carolina, 29605, United States
Saint Francis Cancer Center
Greenville, South Carolina, 29607, United States
Prisma Health Cancer Institute - Eastside
Greenville, South Carolina, 29615, United States
Prisma Health Cancer Institute - Greer
Greer, South Carolina, 29650, United States
Prisma Health Cancer Institute - Seneca
Seneca, South Carolina, 29672, United States
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota, 57117-5134, United States
T C Thompson Children's Hospital
Chattanooga, Tennessee, 37403, United States
East Tennessee Childrens Hospital
Knoxville, Tennessee, 37916, United States
The Children's Hospital at TriStar Centennial
Nashville, Tennessee, 37203, United States
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, 37232, United States
Texas Tech University Health Sciences Center-Amarillo
Amarillo, Texas, 79106, United States
Dell Children's Medical Center of Central Texas
Austin, Texas, 78723, United States
Driscoll Children's Hospital
Corpus Christi, Texas, 78411, United States
Medical City Dallas Hospital
Dallas, Texas, 75230, United States
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas, 75390, United States
El Paso Children's Hospital
El Paso, Texas, 79905, United States
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Houston, Texas, 77030, United States
M D Anderson Cancer Center
Houston, Texas, 77030, United States
Covenant Children's Hospital
Lubbock, Texas, 79410, United States
UMC Cancer Center / UMC Health System
Lubbock, Texas, 79415, United States
Texas Tech University Health Sciences Center-Lubbock
Lubbock, Texas, 79430, United States
Children's Hospital of San Antonio
San Antonio, Texas, 78207, United States
Cancer Therapy and Research Center at The UT Health Science Center at San Antonio
San Antonio, Texas, 78229, United States
Methodist Children's Hospital of South Texas
San Antonio, Texas, 78229, United States
University Hospital
San Antonio, Texas, 78229, United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229, United States
Scott and White Memorial Hospital
Temple, Texas, 76508, United States
Primary Children's Hospital
Salt Lake City, Utah, 84113, United States
Central Vermont Medical Center/National Life Cancer Treatment
Berlin Corners, Vermont, 05602, United States
University of Vermont Medical Center
Burlington, Vermont, 05401, United States
University of Vermont and State Agricultural College
Burlington, Vermont, 05405, United States
University of Virginia Cancer Center
Charlottesville, Virginia, 22908, United States
Inova Fairfax Hospital
Falls Church, Virginia, 22042, United States
Children's Hospital of The King's Daughters
Norfolk, Virginia, 23507, United States
Naval Medical Center - Portsmouth
Portsmouth, Virginia, 23708-2197, United States
VCU Massey Comprehensive Cancer Center
Richmond, Virginia, 23298, United States
Providence Regional Cancer System-Aberdeen
Aberdeen, Washington, 98520, United States
Overlake Medical Center
Bellevue, Washington, 98004, United States
PeaceHealth Saint Joseph Medical Center
Bellingham, Washington, 98225, United States
Providence Regional Cancer System-Centralia
Centralia, Washington, 98531, United States
Swedish Cancer Institute-Edmonds
Edmonds, Washington, 98026, United States
Providence Regional Cancer Partnership
Everett, Washington, 98201, United States
Swedish Cancer Institute-Issaquah
Issaquah, Washington, 98029, United States
Kadlec Clinic Hematology and Oncology
Kennewick, Washington, 99336, United States
Providence Regional Cancer System-Lacey
Lacey, Washington, 98503, United States
PeaceHealth Saint John Medical Center
Longview, Washington, 98632, United States
Pacific Gynecology Specialists
Seattle, Washington, 98104, United States
Seattle Children's Hospital
Seattle, Washington, 98105, United States
Swedish Medical Center-Ballard Campus
Seattle, Washington, 98107, United States
Kaiser Permanente Washington
Seattle, Washington, 98112, United States
Swedish Medical Center-Cherry Hill
Seattle, Washington, 98122-5711, United States
Swedish Medical Center-First Hill
Seattle, Washington, 98122, United States
University of Washington Medical Center - Montlake
Seattle, Washington, 98195, United States
Providence Regional Cancer System-Shelton
Shelton, Washington, 98584, United States
MultiCare Deaconess Cancer and Blood Specialty Center - Downtown
Spokane, Washington, 99204, United States
Providence Sacred Heart Medical Center and Children's Hospital
Spokane, Washington, 99204, United States
MultiCare Deaconess Cancer and Blood Specialty Center - North
Spokane, Washington, 99218, United States
MultiCare Deaconess Cancer and Blood Specialty Center - Valley
Spokane Valley, Washington, 99216, United States
Mary Bridge Children's Hospital and Health Center
Tacoma, Washington, 98405, United States
Madigan Army Medical Center
Tacoma, Washington, 98431, United States
PeaceHealth Southwest Medical Center
Vancouver, Washington, 98664, United States
Providence Saint Mary Regional Cancer Center
Walla Walla, Washington, 99362, United States
North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
Yakima, Washington, 98902, United States
Providence Regional Cancer System-Yelm
Yelm, Washington, 98597, United States
United Hospital Center
Bridgeport, West Virginia, 26330, United States
West Virginia University Charleston Division
Charleston, West Virginia, 25304, United States
WVUH-Berkely Medical Center
Martinsburg, West Virginia, 25401, United States
West Virginia University Healthcare
Morgantown, West Virginia, 26506, United States
Camden Clark Medical Center
Parkersburg, West Virginia, 26101, United States
Gundersen Lutheran Medical Center
La Crosse, Wisconsin, 54601, United States
University of Wisconsin Carbone Cancer Center - University Hospital
Madison, Wisconsin, 53792, United States
Marshfield Medical Center-Marshfield
Marshfield, Wisconsin, 54449, United States
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, 53226, United States
John Hunter Children's Hospital
Hunter Regional Mail Centre, New South Wales, 2310, Australia
Sydney Children's Hospital
Randwick, New South Wales, 2031, Australia
The Children's Hospital at Westmead
Westmead, New South Wales, 2145, Australia
Queensland Children's Hospital
South Brisbane, Queensland, 4101, Australia
Princess Margaret Hospital for Children
Perth, Western Australia, 6008, Australia
Perth Children's Hospital
Perth, Western Australia, 6009, Australia
Alberta Children's Hospital
Calgary, Alberta, T3B 6A8, Canada
University of Alberta Hospital
Edmonton, Alberta, T6G 2B7, Canada
British Columbia Children's Hospital
Vancouver, British Columbia, V6H 3V4, Canada
CancerCare Manitoba
Winnipeg, Manitoba, R3E 0V9, Canada
Janeway Child Health Centre
St. John's, Newfoundland and Labrador, A1B 3V6, Canada
IWK Health Centre
Halifax, Nova Scotia, B3K 6R8, Canada
McMaster Children's Hospital at Hamilton Health Sciences
Hamilton, Ontario, L8N 3Z5, Canada
Kingston Health Sciences Centre
Kingston, Ontario, K7L 2V7, Canada
Children's Hospital
London, Ontario, N6A 5W9, Canada
Children's Hospital of Eastern Ontario
Ottawa, Ontario, K1H 8L1, Canada
Hospital for Sick Children
Toronto, Ontario, M5G 1X8, Canada
The Montreal Children's Hospital of the MUHC
Montreal, Quebec, H3H 1P3, Canada
Centre Hospitalier Universitaire Sainte-Justine
Montreal, Quebec, H3T 1C5, Canada
Jim Pattison Children's Hospital
Saskatoon, Saskatchewan, S7N 0W8, Canada
Saskatoon Cancer Centre
Saskatoon, Saskatchewan, S7N 4H4, Canada
CHU de Quebec-Centre Hospitalier de l'Universite Laval (CHUL)
Québec, G1V 4G2, Canada
Starship Children's Hospital
Grafton, Auckland, 1145, New Zealand
Christchurch Hospital
Christchurch, 8011, New Zealand
HIMA San Pablo Oncologic Hospital
Caguas, 00726, Puerto Rico
San Jorge Children's Hospital
San Juan, 00912, Puerto Rico
University Pediatric Hospital
San Juan, 00926, Puerto Rico
Related Publications (2)
Winsnes K, Bradley JA, Gao Z, Gupta AA, Rothstein DH, Shenoy A, Venkatramani R, Xue W, Arndt C. Intermediate Risk Rhabdomyosarcoma in Very Young Children (Less Than or Equal to 24 Months) Treated on the Prior Children's Oncology Group Protocol ARST1431. Pediatr Blood Cancer. 2026 Jun;73(6):e70293. doi: 10.1002/1545-5017.70293. Epub 2026 Mar 31.
PMID: 41914453DERIVEDGupta AA, Xue W, Harrison DJ, Hawkins DS, Dasgupta R, Wolden S, Shulkin B, Qumseya A, Routh JC, MacDonald T, Feinberg S, Crompton B, Rudzinski ER, Arnold M, Venkatramani R. Addition of temsirolimus to chemotherapy in children, adolescents, and young adults with intermediate-risk rhabdomyosarcoma (ARST1431): a randomised, open-label, phase 3 trial from the Children's Oncology Group. Lancet Oncol. 2024 Jul;25(7):912-921. doi: 10.1016/S1470-2045(24)00255-9.
PMID: 38936378DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Results Reporting Coordinator
- Organization
- Children's Oncology Group
Study Officials
- PRINCIPAL INVESTIGATOR
Abha A Gupta
Children's Oncology Group
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 2, 2015
First Posted
October 5, 2015
Study Start
June 1, 2016
Primary Completion
June 30, 2023
Study Completion (Estimated)
October 27, 2026
Last Updated
May 1, 2026
Results First Posted
October 1, 2024
Record last verified: 2026-04