ClinicalTrials.gov record
A Study to Compare Early Use of Vinorelbine and Maintenance Therapy for Patients With High Risk Rhabdomyosarcoma
ClinicalTrials.gov ID: NCT04994132
Public ClinicalTrials.gov record NCT04994132. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized Phase 3 Trial of Vinorelbine, Dactinomycin, and Cyclophosphamide (VINO-AC) Plus Maintenance Chemotherapy With Vinorelbine and Oral Cyclophosphamide (VINO-CPO) vs Vincristine, Dactinomycin and Cyclophosphamide (VAC) Plus VINO-CPO Maintenance in Patients With High Risk Rhabdomyosarcoma (HR-RMS)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This phase III trial compares the safety and effect of adding vinorelbine to vincristine, dactinomycin, and cyclophosphamide (VAC) for the treatment of patients with high risk rhabdomyosarcoma (RMS). High risk refers to cancer that is likely to recur (come back) after treatment or spread to other parts of the body. This study will also examine if adding maintenance therapy after VAC therapy, with or without vinorelbine, will help get rid of the cancer and/or lower the chance that the cancer comes back. Vinorelbine and vincristine are in a class of medications called vinca alkaloids. They work by stopping cancer cells from growing and dividing and may kill them. Dactinomycin is a type of antibiotic that is only used in cancer chemotherapy. It works by damaging the cell's deoxyribonucleic acid (DNA) and may kill cancer cells. Cyclophosphamide is in a class of medications called alkylating agents. It works by damaging the cell's DNA and may kill cancer cells. It may also lower the body's immune response. Vinorelbine, vincristine, dactinomycin and cyclophosphamide are chemotherapy medications that work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. This trial may have the potential to eliminate rhabdomyosarcoma for a long time or for the rest of patient's life.
Study identification
- NCT ID
- NCT04994132
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 113 participants
Conditions and interventions
Conditions
Interventions
- Biospecimen Collection Procedure
- Bone Marrow Aspiration Procedure
- Bone Marrow Biopsy Procedure
- Bone Scan Procedure
- Computed Tomography Procedure
- Cyclophosphamide Drug
- Dactinomycin Biological
- Magnetic Resonance Imaging Procedure
- Positron Emission Tomography Procedure
- Radiation Therapy Radiation
- Vincristine Sulfate Drug
- Vinorelbine Tartrate Drug
- X-Ray Imaging Procedure
Procedure · Drug · Biological + 1 more
Eligibility (public fields only)
- Age range
- Up to 50 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 14, 2021 (Actual)
- Primary completion
- Jun 30, 2026 (Actual)
- Completion
- Jul 1, 2027 (Estimated)
- Last update posted
- Jul 30, 2026
2021 – 2027
United States locations
- U.S. sites
- 228
- U.S. states
- 46
- U.S. cities
- 163
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Children's Hospital of Alabama | Birmingham | Alabama | 35233 | — |
| USA Health Strada Patient Care Center | Mobile | Alabama | 36604 | — |
| Providence Alaska Medical Center | Anchorage | Alaska | 99508 | — |
| Kingman Regional Medical Center | Kingman | Arizona | 86401 | — |
| Banner Children's at Desert | Mesa | Arizona | 85202 | — |
| Phoenix Childrens Hospital | Phoenix | Arizona | 85016 | — |
| Banner University Medical Center - Tucson | Tucson | Arizona | 85719 | — |
| Arkansas Children's Hospital | Little Rock | Arkansas | 72202-3591 | — |
| Kaiser Permanente-Anaheim | Anaheim | California | 92806 | — |
| PCR Oncology | Arroyo Grande | California | 93420 | — |
| Kaiser Permanente-Bellflower | Bellflower | California | 90706 | — |
| Kaiser Permanente Downey Medical Center | Downey | California | 90242 | — |
| City of Hope Comprehensive Cancer Center | Duarte | California | 91010 | — |
| Kaiser Permanente-Fontana | Fontana | California | 92335 | — |
| Loma Linda University Medical Center | Loma Linda | California | 92354 | — |
| Miller Children's and Women's Hospital Long Beach | Long Beach | California | 90806 | — |
| Children's Hospital Los Angeles | Los Angeles | California | 90027 | — |
| Kaiser Permanente Los Angeles Medical Center | Los Angeles | California | 90027 | — |
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | — |
| Mattel Children's Hospital UCLA | Los Angeles | California | 90095 | — |
| Valley Children's Hospital | Madera | California | 93636 | — |
| UCSF Benioff Children's Hospital Oakland | Oakland | California | 94609 | — |
| Kaiser Permanente-Oakland | Oakland | California | 94611 | — |
| Children's Hospital of Orange County | Orange | California | 92868 | — |
| Lucile Packard Children's Hospital Stanford University | Palo Alto | California | 94304 | — |
| University of California Davis Comprehensive Cancer Center | Sacramento | California | 95817 | — |
| Kaiser Permanente-San Diego Zion | San Diego | California | 92120 | — |
| Rady Children's Hospital - San Diego | San Diego | California | 92123 | — |
| Naval Medical Center -San Diego | San Diego | California | 92134 | — |
| UCSF Medical Center-Mission Bay | San Francisco | California | 94158 | — |
| Children's Hospital Colorado | Aurora | Colorado | 80045 | — |
| Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center | Denver | Colorado | 80218 | — |
| Connecticut Children's Medical Center | Hartford | Connecticut | 06106 | — |
| Smilow Cancer Center/Yale-New Haven Hospital | New Haven | Connecticut | 06510 | — |
| Yale University | New Haven | Connecticut | 06520 | — |
| Alfred I duPont Hospital for Children | Wilmington | Delaware | 19803 | — |
| MedStar Georgetown University Hospital | Washington D.C. | District of Columbia | 20007 | — |
| Children's National Medical Center | Washington D.C. | District of Columbia | 20010 | — |
| Broward Health Medical Center | Fort Lauderdale | Florida | 33316 | — |
| Golisano Children's Hospital of Southwest Florida | Fort Myers | Florida | 33908 | — |
| UF Health Cancer Institute - Gainesville | Gainesville | Florida | 32610 | — |
| Memorial Regional Hospital/Joe DiMaggio Children's Hospital | Hollywood | Florida | 33021 | — |
| Nemours Children's Clinic-Jacksonville | Jacksonville | Florida | 32207 | — |
| University of Miami Miller School of Medicine-Sylvester Cancer Center | Miami | Florida | 33136 | — |
| Nicklaus Children's Hospital | Miami | Florida | 33155 | — |
| Arnold Palmer Hospital for Children | Orlando | Florida | 32806 | — |
| Nemours Children's Hospital | Orlando | Florida | 32827 | — |
| Sacred Heart Hospital | Pensacola | Florida | 32504 | — |
| Tampa General Hospital | Tampa | Florida | 33606 | — |
| Saint Joseph's Hospital/Children's Hospital-Tampa | Tampa | Florida | 33607 | — |
| Saint Mary's Medical Center | West Palm Beach | Florida | 33407 | — |
| Children's Healthcare of Atlanta - Arthur M Blank Hospital | Atlanta | Georgia | 30329 | — |
| Augusta University Medical Center | Augusta | Georgia | 30912 | — |
| Atrium Health Navicent | Macon | Georgia | 31201 | — |
| Memorial Health University Medical Center | Savannah | Georgia | 31404 | — |
| Kapiolani Medical Center for Women and Children | Honolulu | Hawaii | 96826 | — |
| Saint Luke's Cancer Institute - Boise | Boise | Idaho | 83712 | — |
| Lurie Children's Hospital-Chicago | Chicago | Illinois | 60611 | — |
| University of Illinois | Chicago | Illinois | 60612 | — |
| University of Chicago Comprehensive Cancer Center | Chicago | Illinois | 60637 | — |
| Loyola University Medical Center | Maywood | Illinois | 60153 | — |
| Advocate Children's Hospital-Oak Lawn | Oak Lawn | Illinois | 60453 | — |
| Advocate Children's Hospital-Park Ridge | Park Ridge | Illinois | 60068 | — |
| OSF Children's Hospital of Illinois | Peoria | Illinois | 61637 | — |
| Saint John's Hospital | Springfield | Illinois | 62702 | — |
| Southern Illinois University School of Medicine | Springfield | Illinois | 62702 | — |
| Northwestern Medicine Central DuPage Hospital | Winfield | Illinois | 60190 | — |
| Riley Hospital for Children | Indianapolis | Indiana | 46202 | — |
| Ascension Saint Vincent Indianapolis Hospital | Indianapolis | Indiana | 46260 | — |
| Blank Children's Hospital | Des Moines | Iowa | 50309 | — |
| University of Iowa/Holden Comprehensive Cancer Center | Iowa City | Iowa | 52242 | — |
| University of Kentucky/Markey Cancer Center | Lexington | Kentucky | 40536 | — |
| Norton Children's Hospital | Louisville | Kentucky | 40202 | — |
| Children's Hospital New Orleans | New Orleans | Louisiana | 70118 | — |
| Ochsner Medical Center Jefferson | New Orleans | Louisiana | 70121 | — |
| Eastern Maine Medical Center | Bangor | Maine | 04401 | — |
| Maine Children's Cancer Program | Scarborough | Maine | 04074 | — |
| Sinai Hospital of Baltimore | Baltimore | Maryland | 21215 | — |
| Johns Hopkins University/Sidney Kimmel Cancer Center | Baltimore | Maryland | 21287 | — |
| Walter Reed National Military Medical Center | Bethesda | Maryland | 20889-5600 | — |
| Tufts Children's Hospital | Boston | Massachusetts | 02111 | — |
| Tufts Medical Center | Boston | Massachusetts | 02111 | — |
| Massachusetts General Hospital Cancer Center | Boston | Massachusetts | 02114 | — |
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02215 | — |
| UMass Memorial Medical Center - University Campus | Worcester | Massachusetts | 01655 | — |
| C S Mott Children's Hospital | Ann Arbor | Michigan | 48109 | — |
| Bronson Battle Creek | Battle Creek | Michigan | 49017 | — |
| Children's Hospital of Michigan | Detroit | Michigan | 48201 | — |
| Michigan State University | East Lansing | Michigan | 48823 | — |
| Corewell Health Grand Rapids Hospitals - Butterworth Hospital | Grand Rapids | Michigan | 49503 | — |
| Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital | Grand Rapids | Michigan | 49503 | — |
| Trinity Health Grand Rapids Hospital | Grand Rapids | Michigan | 49503 | — |
| Bronson Methodist Hospital | Kalamazoo | Michigan | 49007 | — |
| West Michigan Cancer Center | Kalamazoo | Michigan | 49007 | — |
| Beacon Kalamazoo | Kalamazoo | Michigan | 49048 | — |
| Trinity Health Muskegon Hospital | Muskegon | Michigan | 49444 | — |
| Corewell Health Lakeland Hospitals - Niles Hospital | Niles | Michigan | 49120 | — |
| Cancer and Hematology Centers of Western Michigan - Norton Shores | Norton Shores | Michigan | 49444 | — |
| Corewell Health Reed City Hospital | Reed City | Michigan | 49677 | — |
| Corewell Health Children's | Royal Oak | Michigan | 48073 | — |
| Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center | Saint Joseph | Michigan | 49085 | — |
| Corewell Health Lakeland Hospitals - Saint Joseph Hospital | Saint Joseph | Michigan | 49085 | — |
| Munson Medical Center | Traverse City | Michigan | 49684 | — |
| University of Michigan Health - West | Wyoming | Michigan | 49519 | — |
| Children's Hospitals and Clinics of Minnesota - Minneapolis | Minneapolis | Minnesota | 55404 | — |
| University of Minnesota/Masonic Cancer Center | Minneapolis | Minnesota | 55455 | — |
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | — |
| University of Mississippi Medical Center | Jackson | Mississippi | 39216 | — |
| University of Missouri Children's Hospital | Columbia | Missouri | 65212 | — |
| Children's Mercy Hospitals and Clinics | Kansas City | Missouri | 64108 | — |
| Cardinal Glennon Children's Medical Center | St Louis | Missouri | 63104 | — |
| Washington University School of Medicine | St Louis | Missouri | 63110 | — |
| Mercy Hospital Saint Louis | St Louis | Missouri | 63141 | — |
| Children's Hospital and Medical Center of Omaha | Omaha | Nebraska | 68114 | — |
| University of Nebraska Medical Center | Omaha | Nebraska | 68198 | — |
| Comprehensive Cancer Centers of Nevada - Henderson | Henderson | Nevada | 89052 | — |
| Oncology Las Vegas - Henderson | Henderson | Nevada | 89074 | — |
| OptumCare Cancer Care at Charleston | Las Vegas | Nevada | 89102 | — |
| Radiation Oncology Centers of Nevada Central | Las Vegas | Nevada | 89106 | — |
| Radiation Oncology Centers of Nevada Southeast | Las Vegas | Nevada | 89119 | — |
| Comprehensive Cancer Centers of Nevada - Northwest | Las Vegas | Nevada | 89128 | — |
| Oncology Las Vegas - Tenaya | Las Vegas | Nevada | 89128 | — |
| OptumCare Cancer Care at MountainView | Las Vegas | Nevada | 89128 | — |
| Alliance for Childhood Diseases/Cure 4 the Kids Foundation | Las Vegas | Nevada | 89135 | — |
| Comprehensive Cancer Centers of Nevada - Town Center | Las Vegas | Nevada | 89144 | — |
| Comprehensive Cancer Centers of Nevada-Summerlin | Las Vegas | Nevada | 89144 | — |
| Comprehensive Cancer Centers of Nevada | Las Vegas | Nevada | 89148 | — |
| Comprehensive Cancer Centers of Nevada - Central Valley | Las Vegas | Nevada | 89169 | — |
| OptumCare Cancer Care at Fort Apache | Las Vegas | Nevada | 89183 | — |
| Renown Regional Medical Center | Reno | Nevada | 89502 | — |
| Saint Mary's Regional Medical Center | Reno | Nevada | 89503 | — |
| Radiation Oncology Associates | Reno | Nevada | 89509 | — |
| Cancer Care Specialists - Reno | Reno | Nevada | 89511 | — |
| Hackensack University Medical Center | Hackensack | New Jersey | 07601 | — |
| Morristown Medical Center | Morristown | New Jersey | 07960 | — |
| Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital | New Brunswick | New Jersey | 08903 | — |
| Newark Beth Israel Medical Center | Newark | New Jersey | 07112 | — |
| Saint Joseph's Regional Medical Center | Paterson | New Jersey | 07503 | — |
| Albany Medical Center | Albany | New York | 12208 | — |
| Maimonides Medical Center | Brooklyn | New York | 11219 | — |
| Roswell Park Cancer Institute | Buffalo | New York | 14263 | — |
| The Steven and Alexandra Cohen Children's Medical Center of New York | New Hyde Park | New York | 11040 | — |
| Mount Sinai Hospital | New York | New York | 10029 | — |
| NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center | New York | New York | 10032 | — |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | — |
| NYP/Weill Cornell Medical Center | New York | New York | 10065 | — |
| Stony Brook University Medical Center | Stony Brook | New York | 11794 | — |
| State University of New York Upstate Medical University | Syracuse | New York | 13210 | — |
| Montefiore Medical Center-Einstein Campus | The Bronx | New York | 10461 | — |
| Montefiore Medical Center-Weiler Hospital | The Bronx | New York | 10461 | — |
| Montefiore Medical Center - Moses Campus | The Bronx | New York | 10467 | — |
| New York Medical College | Valhalla | New York | 10595 | — |
| Westchester Medical Center | Valhalla | New York | 10595 | — |
| Mission Hospital | Asheville | North Carolina | 28801 | — |
| Carolinas Medical Center/Levine Cancer Institute | Charlotte | North Carolina | 28203 | — |
| Novant Health Presbyterian Medical Center | Charlotte | North Carolina | 28204 | — |
| East Carolina University | Greenville | North Carolina | 27834 | — |
| Wake Forest University Health Sciences | Winston-Salem | North Carolina | 27157 | — |
| Sanford Broadway Medical Center | Fargo | North Dakota | 58122 | — |
| Children's Hospital Medical Center of Akron | Akron | Ohio | 44308 | — |
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | — |
| Rainbow Babies and Childrens Hospital | Cleveland | Ohio | 44106 | — |
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | — |
| Nationwide Children's Hospital | Columbus | Ohio | 43205 | — |
| Dayton Children's Hospital | Dayton | Ohio | 45404 | — |
| ProMedica Flower Hospital | Sylvania | Ohio | 43560 | — |
| ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital | Toledo | Ohio | 43606 | — |
| University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | 73104 | — |
| Legacy Emanuel Children's Hospital | Portland | Oregon | 97227 | — |
| Oregon Health and Science University | Portland | Oregon | 97239 | — |
| Lehigh Valley Hospital-Cedar Crest | Allentown | Pennsylvania | 18103 | — |
| Geisinger Medical Center | Danville | Pennsylvania | 17822 | — |
| Penn State Children's Hospital | Hershey | Pennsylvania | 17033 | — |
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | — |
| Saint Christopher's Hospital for Children | Philadelphia | Pennsylvania | 19134 | — |
| Children's Hospital of Pittsburgh of UPMC | Pittsburgh | Pennsylvania | 15224 | — |
| Rhode Island Hospital | Providence | Rhode Island | 02903 | — |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | — |
| Prisma Health Richland Hospital | Columbia | South Carolina | 29203 | — |
| Saint Francis Hospital | Greenville | South Carolina | 29601 | — |
| BI-LO Charities Children's Cancer Center | Greenville | South Carolina | 29605 | — |
| Prisma Health Cancer Institute - Faris | Greenville | South Carolina | 29605 | — |
| Saint Francis Cancer Center | Greenville | South Carolina | 29607 | — |
| Prisma Health Cancer Institute - Eastside | Greenville | South Carolina | 29615 | — |
| Prisma Health Cancer Institute - Greer | Greer | South Carolina | 29650 | — |
| Prisma Health Cancer Institute - Seneca | Seneca | South Carolina | 29672 | — |
| Sanford USD Medical Center - Sioux Falls | Sioux Falls | South Dakota | 57117-5134 | — |
| T C Thompson Children's Hospital | Chattanooga | Tennessee | 37403 | — |
| East Tennessee Childrens Hospital | Knoxville | Tennessee | 37916 | — |
| Saint Jude Children's Research Hospital | Memphis | Tennessee | 38105 | — |
| The Children's Hospital at TriStar Centennial | Nashville | Tennessee | 37203 | — |
| Vanderbilt University/Ingram Cancer Center | Nashville | Tennessee | 37232 | — |
| Texas Tech University Health Sciences Center-Amarillo | Amarillo | Texas | 79106 | — |
| Dell Children's Medical Center of Central Texas | Austin | Texas | 78723 | — |
| Driscoll Children's Hospital | Corpus Christi | Texas | 78411 | — |
| Medical City Dallas Hospital | Dallas | Texas | 75230 | — |
| UT Southwestern/Simmons Cancer Center-Dallas | Dallas | Texas | 75390 | — |
| El Paso Children's Hospital | El Paso | Texas | 79905 | — |
| Cook Children's Medical Center | Fort Worth | Texas | 76104 | — |
| Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center | Houston | Texas | 77030 | — |
| UT MD Anderson Cancer Center | Houston | Texas | 77030 | — |
| Covenant Children's Hospital | Lubbock | Texas | 79410 | — |
| UMC Cancer Center / UMC Health System | Lubbock | Texas | 79415 | — |
| Children's Hospital of San Antonio | San Antonio | Texas | 78207 | — |
| Methodist Children's Hospital of South Texas | San Antonio | Texas | 78229 | — |
| Scott and White Memorial Hospital | Temple | Texas | 76508 | — |
| Primary Children's Hospital | Salt Lake City | Utah | 84113 | — |
| University of Vermont and State Agricultural College | Burlington | Vermont | 05405 | — |
| University of Virginia Cancer Center | Charlottesville | Virginia | 22908 | — |
| Inova Fairfax Hospital | Falls Church | Virginia | 22042 | — |
| Children's Hospital of The King's Daughters | Norfolk | Virginia | 23507 | — |
| Naval Medical Center - Portsmouth | Portsmouth | Virginia | 23708-2197 | — |
| VCU Massey Comprehensive Cancer Center | Richmond | Virginia | 23298 | — |
| Carilion Children's | Roanoke | Virginia | 24014 | — |
| Overlake Medical Center | Bellevue | Washington | 98004 | — |
| Valley Medical Center | Renton | Washington | 98055 | — |
| Seattle Children's Hospital | Seattle | Washington | 98105 | — |
| Providence Sacred Heart Medical Center and Children's Hospital | Spokane | Washington | 99204 | — |
| Mary Bridge Children's Hospital and Health Center | Tacoma | Washington | 98405 | — |
| Madigan Army Medical Center | Tacoma | Washington | 98431 | — |
| North Star Lodge Cancer Center at Yakima Valley Memorial Hospital | Yakima | Washington | 98902 | — |
| West Virginia University Charleston Division | Charleston | West Virginia | 25304 | — |
| West Virginia University Healthcare | Morgantown | West Virginia | 26506 | — |
| Saint Vincent Hospital Cancer Center Green Bay | Green Bay | Wisconsin | 54301 | — |
| Saint Vincent Hospital Cancer Center at Saint Mary's | Green Bay | Wisconsin | 54303 | — |
| University of Wisconsin Carbone Cancer Center - University Hospital | Madison | Wisconsin | 53792 | — |
| Marshfield Medical Center-Marshfield | Marshfield | Wisconsin | 54449 | — |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 22 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04994132, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 30, 2026 · Synced Oct 18, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04994132 live on ClinicalTrials.gov.