deltatrials
Active Not Recruiting PHASE3 INTERVENTIONAL 5-arm NCT00980460

Risk-Based Therapy in Treating Younger Patients With Newly Diagnosed Liver Cancer

Treatment of Children With All Stages of Hepatoblastoma With Temsirolimus (NSC#683864) Added to High Risk Stratum Treatment

Sponsor: National Cancer Institute (NCI)

Conditions PRETEXT I Hepatoblastoma PRETEXT II Hepatoblastoma PRETEXT III Hepatoblastoma PRETEXT IV Hepatoblastoma
Interventions Cisplatin Dexrazoxane Doxorubicin Hydrochloride Fluorouracil Irinotecan Hydrochloride Laboratory Biomarker Analysis Liver Transplantation Temsirolimus Therapeutic Conventional Surgery Vincristine Sulfate
Updated 68 times since 2017 Last updated: Mar 12, 2026 Started: Sep 14, 2009 Primary completion: Jun 30, 2020 Completion: Mar 19, 2026
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE3 trial investigates PRETEXT I Hepatoblastoma and PRETEXT II Hepatoblastoma and is currently ongoing. National Cancer Institute (NCI) leads this study, which shows 68 recorded versions since 2009 — indicating substantial longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshot~Feb 2017 – ~Mar 2017 · 28 days · monthly snapshot~Mar 2017 – ~May 2017 · 2 months · monthly snapshot~May 2017 – ~Jun 2017 · 31 days · monthly snapshot~Jun 2017 – ~Dec 2017 · 6 months · monthly snapshot~Dec 2017 – ~Jun 2018 · 6 months · monthly snapshot~Jun 2018 – ~Jul 2018 · 30 days · monthly snapshot~Jul 2018 – ~Aug 2018 · 31 days · monthly snapshot~Aug 2018 – ~Sep 2018 · 31 days · monthly snapshot~Sep 2018 – ~Oct 2018 · 30 days · monthly snapshot~Oct 2018 – ~Nov 2018 · 31 days · monthly snapshot~Nov 2018 – ~Dec 2018 · 30 days · monthly snapshot~Dec 2018 – ~Jan 2019 · 31 days · monthly snapshot~Jan 2019 – ~Mar 2019 · 59 days · monthly snapshot~Mar 2019 – ~Apr 2019 · 31 days · monthly snapshot~Apr 2019 – ~May 2019 · 30 days · monthly snapshot~May 2019 – ~Jun 2019 · 31 days · monthly snapshot~Jun 2019 – ~Jul 2019 · 30 days · monthly snapshot~Jul 2019 – ~Aug 2019 · 31 days · monthly snapshot~Aug 2019 – ~Sep 2019 · 31 days · monthly snapshot~Sep 2019 – ~Oct 2019 · 30 days · monthly snapshot~Oct 2019 – ~Nov 2019 · 31 days · monthly snapshot~Nov 2019 – ~Dec 2019 · 30 days · monthly snapshot~Dec 2019 – ~Jan 2020 · 31 days · monthly snapshot~Jan 2020 – ~Feb 2020 · 31 days · monthly snapshot~Feb 2020 – ~Mar 2020 · 29 days · monthly snapshot~Mar 2020 – ~Apr 2020 · 31 days · monthly snapshot~Apr 2020 – ~May 2020 · 30 days · monthly snapshot~May 2020 – ~Jun 2020 · 31 days · monthly snapshot~Jun 2020 – ~Jul 2020 · 30 days · monthly snapshot~Jul 2020 – ~Aug 2020 · 31 days · monthly snapshot~Aug 2020 – ~Sep 2020 · 31 days · monthly snapshot~Sep 2020 – ~Oct 2020 · 30 days · monthly snapshot~Oct 2020 – ~Nov 2020 · 31 days · monthly snapshot~Nov 2020 – ~Dec 2020 · 30 days · monthly snapshot~Dec 2020 – ~Jan 2021 · 31 days · monthly snapshot~Jan 2021 – ~Feb 2021 · 31 days · monthly snapshot~Feb 2021 – ~Mar 2021 · 28 days · monthly snapshot~Mar 2021 – ~Apr 2021 · 31 days · monthly snapshot~Apr 2021 – ~May 2021 · 30 days · monthly snapshot~May 2021 – ~Jun 2021 · 31 days · monthly snapshot~Jun 2021 – ~Jan 2022 · 7 months · monthly snapshot~Jan 2022 – ~Feb 2022 · 31 days · monthly snapshot~Feb 2022 – ~May 2022 · 3 months · monthly snapshot~May 2022 – ~Jul 2022 · 2 months · monthly snapshot~Jul 2022 – ~Sep 2022 · 2 months · monthly snapshot~Sep 2022 – ~Feb 2023 · 5 months · monthly snapshot~Feb 2023 – ~Jun 2023 · 4 months · monthly snapshot~Jun 2023 – ~Sep 2023 · 3 months · monthly snapshot~Sep 2023 – ~Oct 2023 · 30 days · monthly snapshot~Oct 2023 – ~Nov 2023 · 31 days · monthly snapshot~Nov 2023 – ~Dec 2023 · 30 days · monthly snapshot~Dec 2023 – ~Feb 2024 · 2 months · monthly snapshot~Feb 2024 – ~May 2024 · 3 months · monthly snapshot~May 2024 – ~Jun 2024 · 31 days · monthly snapshot~Jun 2024 – ~Jul 2024 · 30 days · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Oct 2024 · 30 days · monthly snapshot~Oct 2024 – ~Nov 2024 · 31 days · monthly snapshot~Nov 2024 – ~Feb 2025 · 3 months · monthly snapshot~Feb 2025 – ~Mar 2025 · 28 days · monthly snapshot~Mar 2025 – ~May 2025 · 2 months · monthly snapshot~May 2025 – ~Aug 2025 · 3 months · monthly snapshot~Aug 2025 – ~Sep 2025 · 31 days · monthly snapshot~Sep 2025 – ~Dec 2025 · 3 months · monthly snapshot~Dec 2025 – ~Mar 2026 · 3 months · monthly snapshot~Jan 2026 – present · 3 months · monthly snapshot~Mar 2026 – present · 44 days · monthly snapshot

Change History

68 versions recorded

  1. Mar 2026 — Present [monthly]

    Active Not Recruiting PHASE3

  2. Jan 2026 — Present [monthly]

    Active Not Recruiting PHASE3

  3. Dec 2025 — Mar 2026 [monthly]

    Active Not Recruiting PHASE3

  4. Sep 2025 — Dec 2025 [monthly]

    Active Not Recruiting PHASE3

  5. Aug 2025 — Sep 2025 [monthly]

    Active Not Recruiting PHASE3

▶ Show 63 earlier versions

  1. May 2025 — Aug 2025 [monthly]

    Active Not Recruiting PHASE3

  2. Mar 2025 — May 2025 [monthly]

    Active Not Recruiting PHASE3

  3. Feb 2025 — Mar 2025 [monthly]

    Active Not Recruiting PHASE3

  4. Nov 2024 — Feb 2025 [monthly]

    Active Not Recruiting PHASE3

  5. Oct 2024 — Nov 2024 [monthly]

    Active Not Recruiting PHASE3

  6. Sep 2024 — Oct 2024 [monthly]

    Active Not Recruiting PHASE3

  7. Jul 2024 — Sep 2024 [monthly]

    Active Not Recruiting PHASE3

  8. Jun 2024 — Jul 2024 [monthly]

    Active Not Recruiting PHASE3

  9. May 2024 — Jun 2024 [monthly]

    Active Not Recruiting PHASE3

  10. Feb 2024 — May 2024 [monthly]

    Active Not Recruiting PHASE3

  11. Dec 2023 — Feb 2024 [monthly]

    Active Not Recruiting PHASE3

  12. Nov 2023 — Dec 2023 [monthly]

    Active Not Recruiting PHASE3

  13. Oct 2023 — Nov 2023 [monthly]

    Active Not Recruiting PHASE3

  14. Sep 2023 — Oct 2023 [monthly]

    Active Not Recruiting PHASE3

  15. Jun 2023 — Sep 2023 [monthly]

    Active Not Recruiting PHASE3

  16. Feb 2023 — Jun 2023 [monthly]

    Active Not Recruiting PHASE3

  17. Sep 2022 — Feb 2023 [monthly]

    Active Not Recruiting PHASE3

  18. Jul 2022 — Sep 2022 [monthly]

    Active Not Recruiting PHASE3

  19. May 2022 — Jul 2022 [monthly]

    Active Not Recruiting PHASE3

  20. Feb 2022 — May 2022 [monthly]

    Active Not Recruiting PHASE3

  21. Jan 2022 — Feb 2022 [monthly]

    Active Not Recruiting PHASE3

  22. Jun 2021 — Jan 2022 [monthly]

    Active Not Recruiting PHASE3

  23. May 2021 — Jun 2021 [monthly]

    Active Not Recruiting PHASE3

  24. Apr 2021 — May 2021 [monthly]

    Active Not Recruiting PHASE3

  25. Mar 2021 — Apr 2021 [monthly]

    Active Not Recruiting PHASE3

  26. Feb 2021 — Mar 2021 [monthly]

    Active Not Recruiting PHASE3

  27. Jan 2021 — Feb 2021 [monthly]

    Active Not Recruiting PHASE3

  28. Dec 2020 — Jan 2021 [monthly]

    Active Not Recruiting PHASE3

  29. Nov 2020 — Dec 2020 [monthly]

    Active Not Recruiting PHASE3

  30. Oct 2020 — Nov 2020 [monthly]

    Active Not Recruiting PHASE3

  31. Sep 2020 — Oct 2020 [monthly]

    Active Not Recruiting PHASE3

  32. Aug 2020 — Sep 2020 [monthly]

    Active Not Recruiting PHASE3

  33. Jul 2020 — Aug 2020 [monthly]

    Active Not Recruiting PHASE3

  34. Jun 2020 — Jul 2020 [monthly]

    Active Not Recruiting PHASE3

  35. May 2020 — Jun 2020 [monthly]

    Active Not Recruiting PHASE3

  36. Apr 2020 — May 2020 [monthly]

    Active Not Recruiting PHASE3

  37. Mar 2020 — Apr 2020 [monthly]

    Active Not Recruiting PHASE3

  38. Feb 2020 — Mar 2020 [monthly]

    Active Not Recruiting PHASE3

  39. Jan 2020 — Feb 2020 [monthly]

    Active Not Recruiting PHASE3

  40. Dec 2019 — Jan 2020 [monthly]

    Active Not Recruiting PHASE3

  41. Nov 2019 — Dec 2019 [monthly]

    Active Not Recruiting PHASE3

  42. Oct 2019 — Nov 2019 [monthly]

    Active Not Recruiting PHASE3

  43. Sep 2019 — Oct 2019 [monthly]

    Active Not Recruiting PHASE3

  44. Aug 2019 — Sep 2019 [monthly]

    Active Not Recruiting PHASE3

  45. Jul 2019 — Aug 2019 [monthly]

    Active Not Recruiting PHASE3

  46. Jun 2019 — Jul 2019 [monthly]

    Active Not Recruiting PHASE3

  47. May 2019 — Jun 2019 [monthly]

    Active Not Recruiting PHASE3

  48. Apr 2019 — May 2019 [monthly]

    Active Not Recruiting PHASE3

  49. Mar 2019 — Apr 2019 [monthly]

    Active Not Recruiting PHASE3

  50. Jan 2019 — Mar 2019 [monthly]

    Active Not Recruiting PHASE3

  51. Dec 2018 — Jan 2019 [monthly]

    Active Not Recruiting PHASE3

  52. Nov 2018 — Dec 2018 [monthly]

    Active Not Recruiting PHASE3

  53. Oct 2018 — Nov 2018 [monthly]

    Active Not Recruiting PHASE3

  54. Sep 2018 — Oct 2018 [monthly]

    Active Not Recruiting PHASE3

  55. Aug 2018 — Sep 2018 [monthly]

    Active Not Recruiting PHASE3

    Status: Suspended → Active Not Recruiting

  56. Jul 2018 — Aug 2018 [monthly]

    Suspended PHASE3

  57. Jun 2018 — Jul 2018 [monthly]

    Suspended PHASE3

    Status: Recruiting → Suspended

  58. Dec 2017 — Jun 2018 [monthly]

    Recruiting PHASE3

  59. Jun 2017 — Dec 2017 [monthly]

    Recruiting PHASE3

  60. May 2017 — Jun 2017 [monthly]

    Recruiting PHASE3

  61. Mar 2017 — May 2017 [monthly]

    Recruiting PHASE3

  62. Feb 2017 — Mar 2017 [monthly]

    Recruiting PHASE3

  63. Jan 2017 — Feb 2017 [monthly]

    Recruiting PHASE3

    First recorded

Sep 2009

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • National Cancer Institute (NCI)
Data source: National Cancer Institute (NCI)

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Akron, United States , Albany, United States , Albuquerque, United States , Ann Arbor, United States , Asheville, United States , Atlanta, United States , Aurora, United States , Austin, United States , Baltimore, United States , Bangor, United States and 145 more locations