A Study Comparing Higher Dose Chemotherapy Over a Shorter Amount of Time to Lower Dose Chemotherapy Plus Maintenance Over a Longer Amount of Time in Patients With Newly Diagnosed Intermediate-Risk Rhabdomyosarcoma (IR RMS)
Public ClinicalTrials.gov record NCT07466316. 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 Study to Compare VAC (Higher Cyclophosphamide Dose and Intensity) Versus VAC/VI (Lower Cyclophosphamide Dose and Intensity) Plus Maintenance Therapy in Patients With Newly Diagnosed Intermediate-Risk Rhabdomyosarcoma
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This phase III trial compares higher dose chemotherapy, with vincristine, dactinomycin and cyclophosphamide, over a shorter amount of time to lower dose chemotherapy plus maintenance, with vincristine, dactinomycin, cyclophosphamide, irinotecan and vinorelbine, over a longer amount of time, along with standard of care surgery and radiation, in patients with newly diagnosed intermediate risk rhabdomyosarcoma. Vincristine and vinorelbine are in a class of medications called vinca alkaloids. They work by stopping tumor cells from growing and dividing and may kill them. Dactinomycin is a type of antibiotic that is only used in cancer chemotherapy (antineoplastic antibiotic). It works by damaging the cell's DNA and may kill tumor cells. Cyclophosphamide is in a class of medications called alkylating agents. It works by damaging the cell's DNA and may kill tumor cells. It may also lower the body's immune response. Irinotecan is in a class of antineoplastic medications called topoisomerase I inhibitors. It blocks a certain enzyme needed for cell division and DNA repair and may kill tumor cells. It is not yet known if the higher dose chemotherapy over a shorter amount of time or the lower dose chemotherapy with maintenance over a longer amount of time is more effective in the treatment of patient with newly diagnosed, intermediate risk rhabdomyosarcoma.
Study identification
- NCT ID
- NCT07466316
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 342 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
- Irinotecan Hydrochloride Drug
- Lumbar Puncture Procedure
- Lymph Node Biopsy Procedure
- Magnetic Resonance Imaging Procedure
- Positron Emission Tomography Procedure
- Radiation Therapy Radiation
- Resection Procedure
- Survey Administration Other
- Vincristine Sulfate Drug
- Vinorelbine Tartrate Drug
Procedure · Drug · Biological + 2 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
- Jul 13, 2026
- Primary completion
- Mar 30, 2031
- Completion
- Mar 30, 2031
- Last update posted
- Aug 24, 2026
2026 – 2031
United States locations
- U.S. sites
- 86
- U.S. states
- 33
- U.S. cities
- 74
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Children's Hospital of Alabama | Birmingham | Alabama | 35233 | Recruiting |
| USA Health Strada Patient Care Center | Mobile | Alabama | 36604 | Recruiting |
| Arkansas Children's Hospital | Little Rock | Arkansas | 72202-3591 | Recruiting |
| City of Hope Comprehensive Cancer Center | Duarte | California | 91010 | Recruiting |
| Loma Linda University Medical Center | Loma Linda | California | 92354 | Recruiting |
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | Recruiting |
| Mattel Children's Hospital UCLA | Los Angeles | California | 90095 | Recruiting |
| Valley Children's Hospital | Madera | California | 93636 | Recruiting |
| Kaiser Permanente-Oakland | Oakland | California | 94611 | Recruiting |
| Children's Hospital of Orange County | Orange | California | 92868 | Recruiting |
| Children's Hospital Colorado | Aurora | Colorado | 80045 | Recruiting |
| Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center | Denver | Colorado | 80218 | Recruiting |
| Connecticut Children's Medical Center | Hartford | Connecticut | 06106 | Recruiting |
| Alfred I duPont Hospital for Children | Wilmington | Delaware | 19803 | Recruiting |
| Golisano Children's Hospital of Southwest Florida | Fort Myers | Florida | 33908 | Recruiting |
| Memorial Regional Hospital/Joe DiMaggio Children's Hospital | Hollywood | Florida | 33021 | Recruiting |
| Nemours Children's Clinic-Jacksonville | Jacksonville | Florida | 32207 | Recruiting |
| Nemours Children's Hospital | Orlando | Florida | 32827 | Recruiting |
| Nemours Children's Clinic - Pensacola | Pensacola | Florida | 32504 | Recruiting |
| Johns Hopkins All Children's Hospital | St. Petersburg | Florida | 33701 | Recruiting |
| Saint Mary's Medical Center | West Palm Beach | Florida | 33407 | Recruiting |
| Children's Healthcare of Atlanta - Arthur M Blank Hospital | Atlanta | Georgia | 30329 | Recruiting |
| Lurie Children's Hospital-Chicago | Chicago | Illinois | 60611 | Recruiting |
| University of Illinois | Chicago | Illinois | 60612 | Recruiting |
| Riley Hospital for Children | Indianapolis | Indiana | 46202 | Recruiting |
| Blank Children's Hospital | Des Moines | Iowa | 50309 | Recruiting |
| Wesley Medical Center | Wichita | Kansas | 67214 | Recruiting |
| University of Kentucky/Markey Cancer Center | Lexington | Kentucky | 40536 | Not yet recruiting |
| Norton Children's Hospital | Louisville | Kentucky | 40202 | Recruiting |
| MaineHealth Coastal Cancer Treatment Center | Bath | Maine | 04530 | Recruiting |
| MaineHealth Maine Medical Center - Portland | Portland | Maine | 04102 | Recruiting |
| MaineHealth Cancer Care Center of York County | Sanford | Maine | 04073 | Recruiting |
| Maine Children's Cancer Program | Scarborough | Maine | 04074 | Recruiting |
| MaineHealth Maine Medical Center- Scarborough | Scarborough | Maine | 04074 | Recruiting |
| Sinai Hospital of Baltimore | Baltimore | Maryland | 21215 | Recruiting |
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02215 | Recruiting |
| UMass Memorial Medical Center - University Campus | Worcester | Massachusetts | 01655 | Recruiting |
| Bronson Battle Creek | Battle Creek | Michigan | 49017 | Recruiting |
| Corewell Health Grand Rapids Hospitals - Butterworth Hospital | Grand Rapids | Michigan | 49503 | Recruiting |
| Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital | Grand Rapids | Michigan | 49503 | Recruiting |
| Trinity Health Grand Rapids Hospital | Grand Rapids | Michigan | 49503 | Recruiting |
| Bronson Methodist Hospital | Kalamazoo | Michigan | 49007 | Recruiting |
| West Michigan Cancer Center | Kalamazoo | Michigan | 49007 | Recruiting |
| Beacon Kalamazoo | Kalamazoo | Michigan | 49048 | Recruiting |
| Trinity Health Muskegon Hospital | Muskegon | Michigan | 49444 | Recruiting |
| Corewell Health Lakeland Hospitals - Niles Hospital | Niles | Michigan | 49120 | Recruiting |
| Cancer and Hematology Centers of Western Michigan - Norton Shores | Norton Shores | Michigan | 49444 | Suspended |
| Corewell Health Reed City Hospital | Reed City | Michigan | 49677 | Recruiting |
| Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center | Saint Joseph | Michigan | 49085 | Recruiting |
| Corewell Health Lakeland Hospitals - Saint Joseph Hospital | Saint Joseph | Michigan | 49085 | Recruiting |
| Munson Medical Center | Traverse City | Michigan | 49684 | Recruiting |
| University of Michigan Health - West | Wyoming | Michigan | 49519 | Recruiting |
| University of Mississippi Medical Center | Jackson | Mississippi | 39216 | Recruiting |
| Children's Mercy Hospitals and Clinics | Kansas City | Missouri | 64108 | Recruiting |
| Mercy Hospital Saint Louis | St Louis | Missouri | 63141 | Recruiting |
| Children's Hospital and Medical Center of Omaha | Omaha | Nebraska | 68114 | Recruiting |
| University of Nebraska Medical Center | Omaha | Nebraska | 68198 | Recruiting |
| Renown Regional Medical Center | Reno | Nevada | 89502 | Recruiting |
| Albany Medical Center | Albany | New York | 12208 | Recruiting |
| University of Rochester | Rochester | New York | 14642 | Recruiting |
| Montefiore Medical Center - Moses Campus | The Bronx | New York | 10467 | Recruiting |
| Mission Hospital | Asheville | North Carolina | 28801 | Recruiting |
| Children's Hospital Medical Center of Akron | Akron | Ohio | 44308 | Recruiting |
| ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital | Toledo | Ohio | 43606 | Recruiting |
| Legacy Emanuel Children's Hospital | Portland | Oregon | 97227 | Recruiting |
| Lehigh Valley Hospital-Cedar Crest | Allentown | Pennsylvania | 18103 | Recruiting |
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | Recruiting |
| Saint Christopher's Hospital for Children | Philadelphia | Pennsylvania | 19134 | Recruiting |
| Children's Hospital of Pittsburgh of UPMC | Pittsburgh | Pennsylvania | 15224 | Recruiting |
| Rhode Island Hospital | Providence | Rhode Island | 02903 | Recruiting |
| East Tennessee Childrens Hospital | Knoxville | Tennessee | 37916 | Recruiting |
| The Children's Hospital at TriStar Centennial | Nashville | Tennessee | 37203 | Recruiting |
| Dell Children's Medical Center of Central Texas | Austin | Texas | 78723 | Recruiting |
| Driscoll Children's Hospital | Corpus Christi | Texas | 78411 | Recruiting |
| UT Southwestern/Simmons Cancer Center-Dallas | Dallas | Texas | 75390 | Recruiting |
| Methodist Children's Hospital of South Texas | San Antonio | Texas | 78229 | Recruiting |
| University of Texas Health Science Center at San Antonio | San Antonio | Texas | 78229 | Recruiting |
| Primary Children's Hospital | Salt Lake City | Utah | 84113 | Recruiting |
| University of Virginia Cancer Center | Charlottesville | Virginia | 22908 | Recruiting |
| Inova Fairfax Hospital | Falls Church | Virginia | 22042 | Recruiting |
| Children's Hospital of The King's Daughters | Norfolk | Virginia | 23507 | Recruiting |
| Seattle Children's Hospital | Seattle | Washington | 98105 | Recruiting |
| Mary Bridge Children's Hospital and Health Center | Tacoma | Washington | 98405 | Recruiting |
| University of Wisconsin Carbone Cancer Center - Eastpark Medical Center | Madison | Wisconsin | 53718 | Recruiting |
| University of Wisconsin Carbone Cancer Center - University Hospital | Madison | Wisconsin | 53792 | Recruiting |
| Children's Hospital of Wisconsin | Milwaukee | Wisconsin | 53226 | Recruiting |
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 1 non-U.S. site.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07466316, 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 Aug 24, 2026 · Synced Sep 1, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT07466316 live on ClinicalTrials.gov.