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NCT04388839 · ClinicalTrials.gov registry record · Phase 2
Evolutionary Therapy for Rhabdomyosarcoma
A Phase 2 study of Rhabdomyosarcoma, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- Active
- Registry status
- Phase 2
- Development phase
- 12
- Enrollment target
- 18
- Study locations
NCT04388839: Active Phase 2 study of Rhabdomyosarcoma, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
NCT04388839 is a Phase 2 study of Rhabdomyosarcoma that is active but no longer recruiting, run by H. Lee Moffitt Cancer Center and Research Institute. The registered enrollment target is 12 participants, below the 69-participant average among 35 other Rhabdomyosarcoma trials with a reported enrollment target (83% lower). The trial reports 18 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04388839, a Phase 2 study of Rhabdomyosarcoma, is active but no longer recruiting, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 12 participants
- Enrollment target
- 18
- Study locations
Study Summary
This clinical trial will evaluate 4 different strategies of chemotherapy schedules in newly diagnosed participants with metastatic Fusion Positive (alveolar) Rhabdomyosarcoma. The participant and their physician will choose from: Arm A) a first strike therapy, Arm B) a first strike-second strike (maintenance) therapy, Arm C) an adaptively timed therapy, and Arm D) conventional chemotherapy.
Primary Outcome
Participants who choose the first strike treatment will have event free survival assessed at 3 years after initiating treatment. Event free survival is defined as time from treatment initiation to event which includes (1) any recurrence (local or regional, or distant) and (2) death due to any cause.
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- DRUG Vincristine
- DRUG Vinorelbine
- DRUG Actinomycin D
- DRUG Cyclophosphamide Pill
Study Locations (18)
Florida
- University of Florida - Gainesville
- University of Miami - Sylvester Comprehensive Cancer Center - Miami
- Johns Hopkins All Children's Hospital - St. Petersburg
- Moffitt Cancer Center - Tampa
North Carolina
- University of North Carolina Lineberger Comprehensive Cancer Center - Chapel Hill
- Carolinas Medical Center, Levine Cancer Institute - Charlotte
- Duke Children's Hospital - Durham
New York
- Roswell Park Comprehensive Cancer Center - Buffalo
- Montefiore Medical Cancer Center - The Bronx
Ohio
- Cleveland Clinic - Cleveland
- Nationwide Children's Hospital - Columbus
Texas
- University of Texas Southwestern Medical Center - Dallas
- MD Anderson - Houston
Alabama
- University of Alabama at Birmingham Comprehensive Cancer Center - Birmingham
Colorado
- Children's Hospital of Colorado - Aurora
Connecticut
- Connecticut Children's Medical Center - Hartford
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2020-12-29 |
| Est. Completion | 2027-08 |
| Phase | Phase 2 |
What the registry record for NCT04388839 still lists
NCT04388839 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 69-participant average among 35 other Rhabdomyosarcoma trials with a reported enrollment target (83% lower).
The record links to 1 condition, with Rhabdomyosarcoma appearing as the primary indexed condition, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT04388839 lists 18 locations in 10 states (Florida, North Carolina, New York).
Frequently Asked Questions
What is clinical trial NCT04388839 about?
NCT04388839 is a clinical study titled "Evolutionary Therapy for Rhabdomyosarcoma". This clinical trial will evaluate 4 different strategies of chemotherapy schedules in newly diagnosed participants with metastatic Fusion Positive (alveolar) Rhabdomyosarcoma. The participant and their physician will choose from: Arm A) a first strike therapy, Arm B) a first strike-second strike (ma...
What is the current status of trial NCT04388839?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 12 participants. The study started on 2020-12-29. Estimated completion is 2027-08.
What conditions does trial NCT04388839 study?
This clinical trial studies the following conditions: Rhabdomyosarcoma.
What interventions are being tested in trial NCT04388839?
The interventions under investigation include: Cyclophosphamide (DRUG), Vincristine (DRUG), Vinorelbine (DRUG), Actinomycin D (DRUG), Cyclophosphamide Pill (DRUG).
Who is sponsoring clinical trial NCT04388839?
This trial is sponsored by H. Lee Moffitt Cancer Center and Research Institute, which has 502 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04388839 being conducted?
This trial has 18 study locations across Alabama, Colorado, Connecticut, Florida, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04388839's enrollment target sits among peer trials
12 35th of 35 the lowest of 35 other Rhabdomyosarcoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Rhabdomyosarcoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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