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NCT04994132 · ClinicalTrials.gov registry record · Phase 3
A Study to Compare Early Use of Vinorelbine and Maintenance Therapy for Patients With High Risk Rhabdomyosarcoma
A Phase 3 study of Embryonal Rhabdomyosarcoma and Alveolar Rhabdomyosarcoma, sponsored by Children's Oncology Group.
- Active
- Registry status
- Phase 3
- Development phase
- 118
- Enrollment target
- 20
- Study locations
NCT04994132: Active Phase 3 study of Embryonal Rhabdomyosarcoma and Alveolar Rhabdomyosarcoma, sponsored by Children's Oncology Group.
NCT04994132 is a Phase 3 study of Embryonal Rhabdomyosarcoma and Alveolar Rhabdomyosarcoma that is active but no longer recruiting, run by Children's Oncology Group. The registered enrollment target is 118 participants, below the 477-participant average among 3 other Embryonal Rhabdomyosarcoma trials with a reported enrollment target (75% lower). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04994132, a Phase 3 study of Embryonal Rhabdomyosarcoma and Alveolar Rhabdomyosarcoma, is active but no longer recruiting, sponsored by Children's Oncology Group.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 118 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Primary Outcome
Will be estimated using the Kaplan-Meier method and will be compared between the two regimens using a log-rank test.
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Bone Marrow Aspiration
- PROCEDURE Bone Marrow Biopsy
- PROCEDURE Computed Tomography
- PROCEDURE Bone Scan
Study Locations (20)
California
- Kaiser Permanente-Anaheim - Anaheim
- PCR Oncology - Arroyo Grande
- Kaiser Permanente-Bellflower - Bellflower
- Kaiser Permanente Downey Medical Center - Downey
- City of Hope Comprehensive Cancer Center - Duarte
- Kaiser Permanente-Fontana - Fontana
- 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
- Kaiser Permanente Los Angeles Medical Center - Los Angeles
- Cedars Sinai Medical Center - Los Angeles
- Mattel Children's Hospital UCLA - Los Angeles
Arizona
- Kingman Regional Medical Center - Kingman
- Banner Children's at Desert - Mesa
- Phoenix Childrens Hospital - Phoenix
- Banner University Medical Center - Tucson - Tucson
Alabama
- Children's Hospital of Alabama - Birmingham
- USA Health Strada Patient Care Center - Mobile
Alaska
- Providence Alaska Medical Center - Anchorage
Arkansas
- Arkansas Children's Hospital - Little Rock
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 118 participants |
| Start Date | 2021-09-14 |
| Est. Completion | 2026-06-30 |
| Phase | Phase 3 |
What the registry record for NCT04994132 still lists
NCT04994132 is an interventional study that assigns participants to a tested intervention. The registered 118 participants enrollment target is mid-sized for trials with a published cap, below the 477-participant average among 3 other Embryonal Rhabdomyosarcoma trials with a reported enrollment target (75% lower).
The record links to 8 conditions, with Embryonal Rhabdomyosarcoma appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT04994132 names 20 study sites across 5 states, led by California, Arizona, Alabama.
Frequently Asked Questions
What is clinical trial NCT04994132 about?
NCT04994132 is a clinical study titled "A Study to Compare Early Use of Vinorelbine and Maintenance Therapy for Patients With High Risk Rhabdomyosarcoma". 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 pa...
What is the current status of trial NCT04994132?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 118 participants. The study started on 2021-09-14. Estimated completion is 2026-06-30.
What conditions does trial NCT04994132 study?
This clinical trial studies the following conditions: Embryonal Rhabdomyosarcoma, Alveolar Rhabdomyosarcoma, Spindle Cell/Sclerosing Rhabdomyosarcoma, Botryoid-Type Embryonal Rhabdomyosarcoma, Spindle Cell Rhabdomyosarcoma.
What interventions are being tested in trial NCT04994132?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Bone Marrow Aspiration (PROCEDURE), Bone Marrow Biopsy (PROCEDURE), Computed Tomography (PROCEDURE), Bone Scan (PROCEDURE).
Who is sponsoring clinical trial NCT04994132?
This trial is sponsored by Children's Oncology Group, which has 342 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04994132 being conducted?
This trial has 20 study locations across Alabama, Alaska, Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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