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NCT05304585 · ClinicalTrials.gov registry record · Phase 3
Chemotherapy for the Treatment of Patients With Newly Diagnosed Very Low-Risk and Low Risk Fusion Negative Rhabdomyosarcoma
A Phase 3 study of Embryonal Rhabdomyosarcoma and Spindle Cell/Sclerosing Rhabdomyosarcoma, sponsored by Children's Oncology Group.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 205
- Enrollment target
- 20
- Study locations
NCT05304585: Recruiting Phase 3 study of Embryonal Rhabdomyosarcoma and Spindle Cell/Sclerosing Rhabdomyosarcoma, sponsored by Children's Oncology Group.
NCT05304585 is a Phase 3 study of Embryonal Rhabdomyosarcoma and Spindle Cell/Sclerosing Rhabdomyosarcoma that is actively recruiting participants, run by Children's Oncology Group. The registered enrollment target is 205 participants, below the 448-participant average among 3 other Embryonal Rhabdomyosarcoma trials with a reported enrollment target (54% lower). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05304585, a Phase 3 study of Embryonal Rhabdomyosarcoma and Spindle Cell/Sclerosing Rhabdomyosarcoma, is actively recruiting participants, sponsored by Children's Oncology Group.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 205 participants
- Enrollment target
- 20
- Study locations
Study Summary
Rhabdomyosarcoma is a type of cancer that occurs in the soft tissues in the body. This phase III trial aims to maintain excellent outcomes in patients with very low risk rhabdomyosarcoma (VLR-RMS) while decreasing the burden of therapy using treatment with 24 weeks of vincristine and dactinomycin (VA) and examines the use of centralized molecular risk stratification in the treatment of rhabdomyosarcoma. Another aim of the study it to find out how well patients with low risk rhabdomyosarcoma (LR-RMS) respond to standard chemotherapy when patients with VLR-RMS and patients who have rhabdomyosarcoma with DNA mutations get separate treatment. Finally, this study examines the effect of therapy intensification in patients who have RMS cancer with DNA mutations to see if their outcomes can be improved.
Primary Outcome
The Kaplan-Meier method will be used to estimate 3-year FFS along with 80% log-minus-log transformed confidence limits for very low risk (VLR) patients.
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- PROCEDURE Computed Tomography
- PROCEDURE Biopsy Procedure
- PROCEDURE Bone Scan
- BIOLOGICAL Dactinomycin
Study Locations (20)
California
- Kaiser Permanente Downey Medical Center - Downey
- Loma Linda University Medical Center - Loma Linda
- Miller Children's and Women's Hospital Long Beach - Long Beach
- Children's Hospital Los Angeles - Los Angeles
- Cedars Sinai Medical Center - Los Angeles
- Mattel Children's Hospital UCLA - Los Angeles
- Valley Children's Hospital - Madera
- UCSF Benioff Children's Hospital Oakland - Oakland
- Kaiser Permanente-Oakland - Oakland
- Children's Hospital of Orange County - Orange
- Lucile Packard Children's Hospital Stanford University - Palo Alto
- University of California Davis Comprehensive Cancer Center - Sacramento
- Rady Children's Hospital - San Diego - San Diego
- Naval Medical Center -San Diego - San Diego
- UCSF Medical Center-Mission Bay - San Francisco
Alabama
- Children's Hospital of Alabama - Birmingham
- USA Health Strada Patient Care Center - Mobile
Arizona
- Phoenix Childrens Hospital - Phoenix
Arkansas
- Arkansas Children's Hospital - Little Rock
Colorado
- Children's Hospital Colorado - Aurora
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 205 participants |
| Start Date | 2022-08-04 |
| Est. Completion | 2030-06-30 |
| Phase | Phase 3 |
What NCT05304585 shows while recruiting
NCT05304585 is an interventional study that assigns participants to a tested intervention. The registered 205 participants enrollment target is mid-sized for trials with a published cap, below the 448-participant average among 3 other Embryonal Rhabdomyosarcoma trials with a reported enrollment target (54% lower).
The record links to 3 conditions, with Embryonal Rhabdomyosarcoma appearing as the primary indexed condition, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT05304585 names 20 study sites across 5 states, led by California, Alabama, Arizona.
Frequently Asked Questions
What is clinical trial NCT05304585 about?
NCT05304585 is a clinical study titled "Chemotherapy for the Treatment of Patients With Newly Diagnosed Very Low-Risk and Low Risk Fusion Negative Rhabdomyosarcoma". Rhabdomyosarcoma is a type of cancer that occurs in the soft tissues in the body. This phase III trial aims to maintain excellent outcomes in patients with very low risk rhabdomyosarcoma (VLR-RMS) while decreasing the burden of therapy using treatment with 24 weeks of vincristine and dactinomycin (V...
What is the current status of trial NCT05304585?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 205 participants. The study started on 2022-08-04. Estimated completion is 2030-06-30.
What conditions does trial NCT05304585 study?
This clinical trial studies the following conditions: Embryonal Rhabdomyosarcoma, Spindle Cell/Sclerosing Rhabdomyosarcoma, Fusion-Negative Alveolar Rhabdomyosarcoma.
What interventions are being tested in trial NCT05304585?
The interventions under investigation include: Cyclophosphamide (DRUG), Computed Tomography (PROCEDURE), Biopsy Procedure (PROCEDURE), Bone Scan (PROCEDURE), Dactinomycin (BIOLOGICAL).
Who is sponsoring clinical trial NCT05304585?
This trial is sponsored by Children's Oncology Group, which has 342 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05304585 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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