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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

StatusTerminated
PhasePhase 2/3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial terminated Sponsor's reason: Drug supply issues Lead sponsor: Children's Oncology Group to Children's Oncology Group · Study completion date changed from estimate of Aug 19, 2027 to Sep 22, 2026 · Study sites: 9 to 8 · 2 more Show 5 more changesShow less
    • Lead sponsor: Children's Oncology Group to Children's Oncology Group
    • Study completion date changed from estimate of Aug 19, 2027 to Sep 22, 2026
    • Study sites: 9 to 8
    • Eligibility criteria expanded, about 62 words
    • Secondary endpoints: details revised at 1 of 6 entries
  2. Completion pushed from Jul 1, 2027 to Aug 19, 2027v12
  3. Enrollment reduced: 437 → 2 participants Primary completion moved earlier from Dec 31, 2027 to Jun 30, 2026 · Completion moved earlier from Dec 31, 2027 to Jul 1, 2027v11 Show 2 more changesShow less
    • Primary completion moved earlier from Dec 31, 2027 to Jun 30, 2026
    • Completion moved earlier from Dec 31, 2027 to Jul 1, 2027
  4. Re-verified, no change to tracked fieldsv10
  5. Secondary endpoints: 7 to 6 Study sites revised (9)v9 Show 1 more changeShow less
    • Study sites revised (9)

    See this version in full on ClinicalTrials.gov ↗

Show 7 earlier versionsHide 7 earlier versions
  1. Primary and study completion dates: Jul 15, 2032 to Dec 31, 2027v8
  2. Re-verified, no change to tracked fieldsv7
  3. Trial status: Recruiting to Active, Not Recruiting Study sites: 5 to 9 · Start date changed from estimate of Jul 17, 2026 to Nov 10, 2025v6 Show 2 more changesShow less
    • Study sites: 5 to 9
    • Start date changed from estimate of Jul 17, 2026 to Nov 10, 2025
  4. Trial status: Not Yet Recruiting to Recruiting Start date: Dec 12, 2025 to Jul 17, 2026 · Study sites: 0 to 5 · Secondary endpoints: details revised at 1 of 7 entries · 1 morev5 Show 4 more changesShow less
    • Start date: Dec 12, 2025 to Jul 17, 2026
    • Study sites: 0 to 5
    • Secondary endpoints: details revised at 1 of 7 entries
    • Eligibility criteria expanded, about 5 words

    See this version in full on ClinicalTrials.gov ↗

  5. Start date: Sep 13, 2025 to Dec 12, 2025v4
  6. Start date: Jul 15, 2025 to Sep 13, 2025v3
  7. Start date: Apr 15, 2025 to Jul 15, 2025 Interventions: Biopsy (Procedure), Biospecimen Collection (Procedure), Bone Marrow Aspiration (Procedure), Bone Marrow Biopsy (Procedure), Computed… to Biopsy Procedure (Procedure), Biospecimen Collection (Procedure), Bone Marrow Aspiration (Procedure), Bone Marrow Biopsy (Procedure)…v2 Show 1 more changeShow less
    • Interventions: Biopsy (Procedure), Biospecimen Collection (Procedure), Bone Marrow Aspiration (Procedure), Bone Marrow Biopsy (Procedure), Computed… to Biopsy Procedure (Procedure), Biospecimen Collection (Procedure), Bone Marrow Aspiration (Procedure), Bone Marrow Biopsy (Procedure)…
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06820957
Lead Sponsor Children's Oncology Group
Conditions CIC-Rearranged Sarcoma, Metastatic Ewing Sarcoma, Metastatic High Grade Sarcoma, Metastatic Undifferentiated Round Cell Sarcoma, Metastatic Undifferentiated Sarcoma, Not Otherwise Specified, Round Cell Sarcoma With EWSR1-non-ETS Fusion, Sarcoma With BCOR Genetic Alterations
Enrollment 2 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov