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A Multi-institutional Study for Treatment of Children With Newly Diagnosed Hepatoblastoma Using a Modified PHITT Strategy

StatusRecruiting
PhasePhase 3
Started
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Record History

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  1. Primary completion date: Mar 31, 2026 to Mar 31, 2027v10
  2. Re-verified, no change to tracked fieldsv9
  3. Collaborators: 2 to 1v8
  4. 3 versions Re-verified since Jul 23, 2022, no change to tracked fieldsv5-v7
  5. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Feb 20, 2021 to Mar 1, 2021
    • Site details revised
    v4
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  1. Primary endpoints revised (2)
    • Interventions: Biopsy (Procedure), Block 1 to 3 Group D (Drug), Cisplatin, 5-Fluorouracil, Vincristine, Doxorubicin-Group C (Drug), Consolidation -Group… to Biopsy (Procedure), Block 1 to 3 (Cisplatin, Doxorubicin) Group D (Drug), Cisplatin, 5-Fluorouracil, Vincristine, Doxorubicin-Group C…
    • Secondary endpoints revised (2)
    v3
  2. Primary completion date: Mar 31, 2025 to Mar 31, 2026v2 Show 7 more changesShow less
    • Start date: Jun 1, 2020 to Feb 20, 2021
    • Trial status: Recruiting to Not Yet Recruiting
    • Study completion date: Sep 30, 2025 to Sep 30, 2027
    • Interventions: Sodium Thiosulfate Injection (Drug) to Biopsy (Procedure), Block 1 to 3 Group D (Drug), Cisplatin, 5-Fluorouracil, Vincristine, Doxorubicin-Group C (Drug), Consolidation -Group…
    • Site details revised
    • Study arms: 8 to 4
    • Study title expanded, about 2 words
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
A Phase 3 multi-institutional study for treatment of children with newly diagnosed hepatoblastoma using a modified Paediatric Hepatic International Tumour Trial (PHITT) strategy incorporating a randomized assessment of sodium thiosulfate as auditory protection for children with localized disease, and response adapted therapy for patients with metastatic disease
Trial Details
NCT Number NCT04478292
Lead Sponsor Shanghai Children's Medical Center
Collaborators: Shanghai Children's Hospital
Conditions
(from sponsor)		 Hepatoblastoma
Related terms Hepatoblastoma
Enrollment 330 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov