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A Study Using Risk Factors to Determine Treatment for Children With Favorable Histology Wilms Tumors (FHWT)

StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial sites expanded: 159 → 169 locations Eligibility criteria revisedv20 Show 1 more changeShow less
    • Eligibility criteria revised

    See this version in full on ClinicalTrials.gov ↗

  2. Trial sites expanded: 153 → 159 locationsv19
  3. Site details revised at 1 of 153 sitesv18
  4. Eligibility criteria expanded, about 21 words Secondary endpoints: details revised at 1 of 1 entry · Study description expanded, about 10 wordsv17 Show 2 more changesShow less
    • Secondary endpoints: details revised at 1 of 1 entry
    • Study description expanded, about 10 words

    See this version in full on ClinicalTrials.gov ↗

  5. Study sites: 148 to 153v16
Show 14 earlier versionsHide 14 earlier versions
  1. Study sites: 118 to 148v15
  2. Study sites: 106 to 118v14
  3. Study sites: 90 to 106v13
  4. Study sites: 69 to 90 Eligibility criteria expanded, about 104 words · Study description expanded, about 14 wordsv12 Show 2 more changesShow less
    • Eligibility criteria expanded, about 104 words
    • Study description expanded, about 14 words

    See this version in full on ClinicalTrials.gov ↗

  5. Primary endpoint revised Study sites: 40 to 69 · Eligibility criteria shortened, about 81 words · Secondary endpoint revised · 2 morev11 Show 5 more changesShow less
    • Study sites: 40 to 69
    • Eligibility criteria shortened, about 81 words
    • Secondary endpoint revised
    • Study description expanded, about 379 words
    • Study arms: 46 to 48

    See this version in full on ClinicalTrials.gov ↗

  6. Study sites: 8 to 40v10
  7. Study sites: 7 to 8v9
  8. Study sites: 1 to 7 Start date changed from estimate of Dec 23, 2025 to Apr 15, 2025v8 Show 1 more changeShow less
    • Start date changed from estimate of Dec 23, 2025 to Apr 15, 2025
  9. Trial status: Not Yet Recruiting to Recruiting Start date: Mar 31, 2025 to Dec 23, 2025 · Study sites: 0 to 1v7 Show 2 more changesShow less
    • Start date: Mar 31, 2025 to Dec 23, 2025
    • Study sites: 0 to 1
  10. Primary endpoint revised Eligibility criteria expanded, about 115 words · Secondary endpoint revisedv6 Show 2 more changesShow less
    • Eligibility criteria expanded, about 115 words
    • Secondary endpoint revised

    See this version in full on ClinicalTrials.gov ↗

  11. Start date: Dec 31, 2024 to Mar 31, 2025v5
  12. Start date: Sep 10, 2024 to Dec 31, 2024v4
  13. Start date: Jun 12, 2024 to Sep 10, 2024v3
  14. Re-verified, no change to tracked fieldsv2
  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 III trial studies using risk factors in determining treatment for children with favorable tissue (histology) Wilms tumors (FHWT). Wilms Tumor is the most common type of kidney cancer in children, and FHWT is the most common subtype. Previous large clinical trials have established treatment plans that are likely to cure most children with FHWT, however some children still have their cancer come back (called relapse) and not all survive. Previous research has identified features of FHWT that are associated with higher or lower risks of relapse. The term "risk" refers to the chance of the cancer coming back after treatment. Using results of tumor histology tests, biology tests, and response to therapy may be able to improve treatment for children with FHWT.
Trial Details
NCT Number NCT06401330
Lead Sponsor Children's Oncology Group
Conditions Stage I Mixed Cell Type Kidney Wilms Tumor, Stage II Mixed Cell Type Kidney Wilms Tumor, Stage III Mixed Cell Type Kidney Wilms Tumor, Stage IV Mixed Cell Type Kidney Wilms Tumor
Enrollment 1,656 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov