Vincristine, Dactinomycin, and Cyclophosphamide With or Without Radiation Therapy in Treating Patients With Newly Diagnosed Low-Risk Rhabdomyosarcoma
5 other identifiers
interventional
390
6 countries
163
Brief Summary
This phase III trial is studying how well combination chemotherapy and radiation therapy work in treating patients with newly diagnosed low-risk rhabdomyosarcoma. Drugs used in chemotherapy, such as vincristine, dactinomycin, and cyclophosphamide, work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy with radiation therapy may kill more tumor cells. It is not yet known which treatment regimen is more effective in treating low-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 Sep 2004
Longer than P75 for phase_3
163 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
January 9, 2004
CompletedFirst Posted
Study publicly available on registry
January 12, 2004
CompletedStudy Start
First participant enrolled
September 4, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 13, 2012
CompletedResults Posted
Study results publicly available
April 11, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2021
CompletedNovember 19, 2021
November 1, 2021
7.9 years
January 9, 2004
December 16, 2013
November 17, 2021
Conditions
Outcome Measures
Primary Outcomes (3)
Percentage of Patients With Low-risk Rhabdomyosarcoma in Subset 1 Failure Free at 5 Years Following Study Entry
Kaplan Meier estimate of failure free survival at 5 years, where failure free survival is defined as the time to relapse, progression, second malignancy, and death whichever occurs first.
From enrollment up to 5 years
Percentage of Patients With Stage 1, Clinical Group IIB or C (Node Positive) or Stage 2 Failure Free at 5 Years Following Study Entry
Kaplan Meier estimate of failure free survival at 5 years, where failure free survival is defined as the time to relapse, progression, second malignancy, and death whichever occurs first.
From enrollment up to 5 years
Percentage of Patients With Low-risk Rhabdomyosarcoma in Subset 2 Failure Free at 5 Years Following Study Entry
Kaplan Meier estimate of failure free survival at 5 years, where failure free survival is defined as the time to relapse, progression, second malignancy, and death whichever occurs first.
From enrollment up to 5 years
Secondary Outcomes (3)
Cumulative Incidence of Patients Who Receive Reduced Doses of Radiation Therapy
From enrollment up to 5 years
Percentage of Patients With Delayed Surgical Procedures
At 13 weeks after induction
Cumulative Incidence of Group III Patients Who Received With Reduced Radiotherapy Dose
From enrollment up to 20 weeks
Study Arms (2)
Regimen I (chemotherapy, radiotherapy)
EXPERIMENTALPatients receive VAC chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 1-9 and dactinomycin IV over 1 minute and cyclophosphamide IV over 1 hour on day 1 of weeks 1, 4, 7, and 10; VA chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 13-21 and dactinomycin IV over 1 minute on day 1 of weeks 13, 16, 19, and 22 (dactinomycin is omitted during radiation therapy); and radiation therapy, 5 days a week, beginning on week 13 and continuing for 4-7 weeks, depending on prescribed dose. Some patients do not receive radiation therapy; some start it at week 24. (closed to accrual as of 08/13/2010)
Regimen II (chemotherapy, radiotherapy, surgery)
EXPERIMENTALPatients receive VAC chemotherapy and radiation therapy as in regimen I and VA chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 13-21, 25-33, and 37-45 and dactinomycin IV over 1 minute on day 1 of weeks 13, 16, 19, 22, 25, 28, 31, 34, 37, 40, 43, and 46 (dactinomycin is omitted during radiation therapy). Some patients do not receive radiation therapy; some start it at week 13 and some at week 24. Some patients have conventional surgery (second-look) at Week 13 (closed to accrual as of 9/23/2011).
Interventions
Some patients may undergo second-look surgery
Given IV
Given IV
Given IV
Undergo radiotherapy
Eligibility Criteria
You may qualify if:
- Histologically confirmed newly diagnosed embryonal rhabdomyosarcoma (RMS), botryoid or spindle cell variants of embryonal RMS, or embryonal ectomesenchymoma, meeting criteria for 1 of the following subsets:
- Subset 1, defined by meeting 1 of the following criteria (closed to accrual as of 08/13/2010):
- Stage 1 and clinical group I (completely resected) or II (microscopic residual disease and/or regional lymph node involvement) disease
- Stage 1 and clinical group III (gross residual disease) disease arising in the orbit
- Stage 2 and clinical group I or II disease
- Subset 2, defined by meeting 1 of the following criteria (closed to accrual as of 09/23/2011):
- Stage 1 and clinical group III disease arising in a non-orbit site
- Stage 3 and clinical group I or II disease
- Prior staging ipsilateral retroperitoneal lymph node dissection required for all patients age 10 and over with paratesticular tumors and patients under 10 years of age with clinically or radiographically involved lymph nodes (except when extensive lymph node involvement is identified by imaging studies)
- If there is extensive gross node involvement only confirmatory node biopsy is recommended and the patient is classified as Clinical Group III
- Prior regional lymph node sampling required for patients with extremity tumors
- None of the following diagnoses:
- Intermediate-risk embryonal RMS
- Metastatic embryonal RMS
- Alveolar RMS
- +25 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Children's Oncology Grouplead
- National Cancer Institute (NCI)collaborator
Study Sites (163)
University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
Phoenix Childrens Hospital
Phoenix, Arizona, 85016, United States
University of Arizona Health Sciences Center
Tucson, Arizona, 85724, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205, United States
Children's Oncology Group
Arcadia, California, 91006-3776, United States
Southern California Permanente Medical Group
Downey, California, 90242, United States
Loma Linda University Medical Center
Loma Linda, California, 92354, United States
Miller Children's Hospital
Long Beach, California, 90806, United States
Children's Hospital Los Angeles
Los Angeles, California, 90027, United States
Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
Children's Hospital Central California
Madera, California, 93636-8762, United States
Children's Hospital and Research Center at Oakland
Oakland, California, 94609-1809, United States
Kaiser Permanente-Oakland
Oakland, California, 94611, United States
Childrens Hospital of Orange County
Orange, California, 92868-3874, United States
Lucile Packard Children's Hospital Stanford University
Palo Alto, California, 94304, United States
UC Davis Comprehensive Cancer Center
Sacramento, California, 95817, United States
Rady Children's Hospital - San Diego
San Diego, California, 92123, United States
University of California San Francisco Medical Center-Parnassus
San Francisco, California, 94143, 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
Children's National Medical Center
Washington D.C., District of Columbia, 20010, United States
Broward Health Medical Center
Fort Lauderdale, Florida, 33316, United States
Memorial Healthcare System - Joe DiMaggio Children's Hospital
Hollywood, Florida, 33021, United States
Nemours Children's Clinic - Jacksonville
Jacksonville, Florida, 32207-8426, United States
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, 33136, United States
Miami Children's Hospital
Miami, Florida, 33155, United States
Baptist Hospital of Miami
Miami, Florida, 33176, United States
M D Anderson Cancer Center- Orlando
Orlando, Florida, 32806, United States
Nemours Children's Clinic - Pensacola
Pensacola, Florida, 32504, United States
All Children's Hospital
St. Petersburg, Florida, 33701, United States
Saint Joseph Children's Hospital of Tampa
Tampa, Florida, 33607, United States
Saint Mary's Hospital
West Palm Beach, Florida, 33407, United States
Children's Healthcare of Atlanta - Egleston
Atlanta, Georgia, 30322, United States
Memorial Health University Medical Center
Savannah, Georgia, 31403, United States
University of Hawaii
Honolulu, Hawaii, 96813, United States
Tripler Army Medical Center
Honolulu, Hawaii, 96859, United States
Saint Luke's Mountain States Tumor Institute
Boise, Idaho, 83712, United States
University of Illinois
Chicago, Illinois, 60612, United States
Childrens Memorial Hospital
Chicago, Illinois, 60614, United States
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, 60637-1470, United States
Advocate Hope Children's Hospital
Oak Lawn, Illinois, 60453, United States
Advocate Lutheran General Hospital
Park Ridge, Illinois, 60068, United States
Saint Jude Midwest Affiliate
Peoria, Illinois, 61602, United States
Southern Illinois University
Springfield, Illinois, 62702, United States
Indiana University Medical Center
Indianapolis, Indiana, 46202, United States
Raymond Blank Children's Hospital
Des Moines, Iowa, 50309, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242, United States
University of Kentucky
Lexington, Kentucky, 40536, United States
Kosair Children's Hospital
Louisville, Kentucky, 40202, United States
Tulane University Health Sciences Center
New Orleans, Louisiana, 70112, United States
Children's Hospital-Main Campus
New Orleans, Louisiana, 70118, 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, 21201-1595, United States
Sinai Hospital of Baltimore
Baltimore, Maryland, 21215, United States
Johns Hopkins University
Baltimore, Maryland, 21287-8936, United States
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115, United States
Baystate Medical Center
Springfield, Massachusetts, 01199, United States
C S Mott Children's Hospital
Ann Arbor, Michigan, 48109, United States
Wayne State University
Detroit, Michigan, 48202, United States
Hurley Medical Center
Flint, Michigan, 48502, United States
Helen DeVos Children's Hospital at Spectrum Health
Grand Rapids, Michigan, 49503, United States
Michigan State University - Breslin Cancer Center
Lansing, Michigan, 48910, United States
William Beaumont Hospital
Royal Oak, Michigan, 48073, United States
Children's Hospitals and Clinics of Minnesota - Minneapolis
Minneapolis, Minnesota, 55404, United States
University of Minnesota Medical Center-Fairview
Minneapolis, Minnesota, 55455, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216, United States
The Childrens Mercy Hospital
Kansas City, Missouri, 64108, United States
Cardinal Glennon Children's Medical Center
St Louis, Missouri, 63104, United States
Washington University School of Medicine
St Louis, Missouri, 63110, 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
Nevada Cancer Research Foundation CCOP
Las Vegas, Nevada, 89106, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756, United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
UMDNJ - Robert Wood Johnson University Hospital
New Brunswick, New Jersey, 08903, United States
Newark Beth Israel Medical Center
Newark, New Jersey, 07112, United States
University of New Mexico Cancer Center
Albuquerque, New Mexico, 87106, United States
Albany Medical Center
Albany, New York, 12208, United States
Brooklyn Hospital Center
Brooklyn, New York, 11201, United States
Roswell Park Cancer Institute
Buffalo, New York, 14263, United States
The Steven and Alexandra Cohen Children's Medical Center of New York
New Hyde Park, New York, 11040, United States
Mount Sinai Medical Center
New York, New York, 10029, United States
Columbia University Medical 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
State University of New York Upstate Medical University
Syracuse, New York, 13210, United States
Montefiore Medical Center
The Bronx, New York, 10467-2490, United States
New York Medical College
Valhalla, New York, 10595, United States
Mission Hospitals Inc
Asheville, North Carolina, 28801, United States
University of North Carolina
Chapel Hill, North Carolina, 27599, United States
Presbyterian Hospital
Charlotte, North Carolina, 28204, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157, 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
The Children's Medical Center of Dayton
Dayton, Ohio, 45404, United States
Legacy Emanuel Hospital and Health Center
Portland, Oregon, 97227, United States
Oregon Health and Science University
Portland, Oregon, 97239, United States
Lehigh Valley Hospital - Muhlenberg
Bethlehem, Pennsylvania, 18017, United States
Geisinger Medical Center
Danville, Pennsylvania, 17822-2001, United States
Penn State Hershey 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
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Greenville Cancer Treatment Center
Greenville, South Carolina, 29605, United States
T C Thompson Children's Hospital
Chattanooga, Tennessee, 37403, United States
East Tennessee Childrens Hospital
Knoxville, Tennessee, 37916, United States
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105, United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232, United States
Driscoll Children's Hospital
Corpus Christi, Texas, 78411, United States
Medical City Dallas Hospital
Dallas, Texas, 75230, United States
University of Texas Southwestern Medical Center
Dallas, Texas, 75390, United States
Cook Children's Medical Center
Fort Worth, Texas, 76104, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
M D Anderson Cancer Center
Houston, Texas, 77030, United States
Covenant Children's Hospital
Lubbock, Texas, 79410, United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229-3900, United States
Methodist Children's Hospital of South Texas
San Antonio, Texas, 78229, United States
Scott and White Memorial Hospital
Temple, Texas, 76508, United States
Primary Children's Medical Center
Salt Lake City, Utah, 84113, United States
University of Vermont
Burlington, Vermont, 05401, United States
University of Virginia
Charlottesville, Virginia, 22908, United States
Inova Fairfax Hospital
Falls Church, Virginia, 22042, United States
Childrens Hospital-King's Daughters
Norfolk, Virginia, 23507, United States
Virginia Commonwealth University
Richmond, Virginia, 23298, United States
Seattle Children's Hospital
Seattle, Washington, 98105, United States
Providence Sacred Heart Medical Center and Children's Hospital
Spokane, Washington, 99204, United States
West Virginia University Charleston
Charleston, West Virginia, 25304, United States
Saint Vincent Hospital
Green Bay, Wisconsin, 54301, United States
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, 53792, United States
Midwest Children's Cancer Center
Milwaukee, Wisconsin, 53226, United States
Sydney Children's Hospital
Randwick, New South Wales, 2031, Australia
The Children's Hospital at Westmead
Sydney, New South Wales, 2145, Australia
Sydney West Area Health Service-Westmead Hospital
Westmead, New South Wales, 2145, Australia
Royal Brisbane and Women's Hospital
Herston, Queensland, 4029, Australia
Women's and Children's Hospital-Adelaide
North Adelaide, South Australia, 5006, Australia
Royal Children's Hospital
Parkville, Victoria, 3052, Australia
Princess Margaret Hospital for Children
Perth, Western Australia, 6008, 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
Chedoke-McMaster Hospitals
Hamilton, Ontario, L8S 4L8, Canada
Cancer Centre of Southeastern Ontario at Kingston General Hospital
Kingston, Ontario, K7L 5P9, 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
Hospital Sainte-Justine
Montreal, Quebec, H3T 1C5, Canada
Centre Hospitalier Universitaire de Quebec
Ste-Foy, Quebec, G1V 4G2, Canada
Allan Blair Cancer Centre
Regina, Saskatchewan, S4T 7T1, Canada
Starship Children's Hospital
Grafton, Auckland, 1145, New Zealand
Christchurch Hospital
Christchurch, 8011, New Zealand
San Jorge Children's Hospital
Santurce, 00912, Puerto Rico
Swiss Pediatric Oncology Group - Geneva
Geneva, 1205, Switzerland
Swiss Pediatric Oncology Group - Lausanne
Lausanne, 1011, Switzerland
Related Publications (2)
Woolson RF (1981) Rank-tests and a one-sample log-rank test for comparing observed survival-data to a standard population. Biometrics 37: 687-696.
BACKGROUNDProia AD. Spindle Cell/Sclerosing Rhabdomyosarcoma of the Orbit. Ophthalmic Plast Reconstr Surg. 2023 Jan-Feb 01;39(1):e17-e20. doi: 10.1097/IOP.0000000000002252. Epub 2022 Jul 13.
PMID: 35829629DERIVED
Related Links
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
David Walterhouse, MD
Children's Oncology Group
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 9, 2004
First Posted
January 12, 2004
Study Start
September 4, 2004
Primary Completion
August 13, 2012
Study Completion
September 30, 2021
Last Updated
November 19, 2021
Results First Posted
April 11, 2014
Record last verified: 2021-11