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NCT06820957 · ClinicalTrials.gov registry record · Phase 2
Testing a New Combination of Anti-cancer Drugs in Patients Newly Diagnosed With Ewing Sarcoma Who Have Cancer That Has Spread to Other Parts of the Body
A Phase 2 study of Metastatic Ewing Sarcoma and CIC-Rearranged Sarcoma, sponsored by Children's Oncology Group.
- Active
- Registry status
- Phase 2
- Development phase
- 437
- Enrollment target
- 9
- Study locations
NCT06820957: Active Phase 2 study of Metastatic Ewing Sarcoma and CIC-Rearranged Sarcoma, sponsored by Children's Oncology Group.
NCT06820957 is a Phase 2 study of Metastatic Ewing Sarcoma and CIC-Rearranged Sarcoma that is active but no longer recruiting, run by Children's Oncology Group. The registered enrollment target is 437 participants, above the 116-participant average among 3 other Metastatic Ewing Sarcoma trials with a reported enrollment target (277% higher). The trial reports 9 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06820957, a Phase 2 study of Metastatic Ewing Sarcoma and CIC-Rearranged Sarcoma, is active but no longer recruiting, sponsored by Children's Oncology Group.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 437 participants
- Enrollment target
- 9
- Study locations
Study Summary
This phase II/III trial compares the effect of vincristine, irinotecan, and regorafenib (VIrR) in combination with vincristine, doxorubicin, cyclophosphamide (VDC), ifosfamide and etoposide (IE) to usual treatment with VDC/IE for the treatment of newly diagnosed Ewing sarcoma or other round cell sarcomas that have spread from where they first started (primary site) to other places in the body (metastatic). Vincristine is in a class of medications called vinca alkaloids. It works by stopping tumor cells from growing and dividing and may kill them. Irinotecan is in a class of antineoplastic medications called topoisomerase I inhibitors. It blocks a certain enzyme needed for cell division and deoxyribonucleic acid (DNA) repair and may kill tumor cells. Regorafenib, a type of kinase inhibitor and a type of antiangiogenesis agent, blocks certain proteins, which may help keep tumor cells from growing. It may also prevent the growth of new blood vessels that tumors need to grow. Doxorubicin is in a class of medications called anthracyclines. Doxorubicin damages the cell's DNA and may kill tumor cells. It also blocks a certain enzyme needed for cell division and DNA repair. 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. Ifosfamide, a type of alkylating agent and a type of antimetabolite, attaches to DNA in cells and may kill tumor cells. Etoposide is in a class of medications known as podophyllotoxin derivatives. It blocks a certain enzyme needed for cell division and DNA repair and may kill tumor cells. Giving VIrR/VDC/IE may be more effective than usual treatment with VDC/IE in treating patients with newly diagnosed metastatic Ewing sarcoma or other round cell sarcomas.
Primary Outcome
Analysis will be done by associating each patient's outcome with the individual's randomized treatment assignment. The associated statistical tests will be stratified according to grouping.
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Bone Marrow Aspiration
- PROCEDURE Bone Marrow Biopsy
- PROCEDURE Computed Tomography
- PROCEDURE Biopsy Procedure
Study Locations (9)
Illinois
- Lurie Children's Hospital-Chicago - Chicago
- Saint Jude Midwest Affiliate - Peoria
South Carolina
- Prisma Health Richland Hospital - Columbia
- BI-LO Charities Children's Cancer Center - Greenville
Alabama
- Children's Hospital of Alabama - Birmingham
Hawaii
- Kapiolani Medical Center for Women and Children - Honolulu
New York
- NYU Langone Hospital - Long Island - Mineola
Pennsylvania
- Saint Christopher's Hospital for Children - Philadelphia
Tennessee
- East Tennessee Childrens Hospital - Knoxville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 437 participants |
| Start Date | 2025-11-10 |
| Est. Completion | 2027-12-31 |
| Phase | Phase 2 |
What the registry record for NCT06820957 still lists
NCT06820957 is an interventional study that assigns participants to a tested intervention. The registered 437 participants enrollment target is mid-sized for trials with a published cap, above the 116-participant average among 3 other Metastatic Ewing Sarcoma trials with a reported enrollment target (277% higher).
The record links to 7 conditions, with Metastatic Ewing Sarcoma appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT06820957 lists 9 locations in 7 states (Illinois, South Carolina, Alabama).
Frequently Asked Questions
What is clinical trial NCT06820957 about?
NCT06820957 is a clinical study titled "Testing a New Combination of Anti-cancer Drugs in Patients Newly Diagnosed With Ewing Sarcoma Who Have Cancer That Has Spread to Other Parts of the Body". This phase II/III trial compares the effect of vincristine, irinotecan, and regorafenib (VIrR) in combination with vincristine, doxorubicin, cyclophosphamide (VDC), ifosfamide and etoposide (IE) to usual treatment with VDC/IE for the treatment of newly diagnosed Ewing sarcoma or other round cell sar...
What is the current status of trial NCT06820957?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 437 participants. The study started on 2025-11-10. Estimated completion is 2027-12-31.
What conditions does trial NCT06820957 study?
This clinical trial studies the following conditions: Metastatic Ewing Sarcoma, CIC-Rearranged Sarcoma, Round Cell Sarcoma With EWSR1-non-ETS Fusion, Metastatic High Grade Sarcoma, Metastatic Undifferentiated Round Cell Sarcoma.
What interventions are being tested in trial NCT06820957?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Bone Marrow Aspiration (PROCEDURE), Bone Marrow Biopsy (PROCEDURE), Computed Tomography (PROCEDURE), Biopsy Procedure (PROCEDURE).
Who is sponsoring clinical trial NCT06820957?
This trial is sponsored by Children's Oncology Group, which has 342 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06820957 being conducted?
This trial has 9 study locations across Alabama, Hawaii, Illinois, New York, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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