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Cisplatin and Combination Chemotherapy in Treating Children and Young Adults With Hepatoblastoma or Liver Cancer After Surgery

StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 3 months later Dec 31, 2026 → Mar 31, 2027
See other at-risk trials from Children's Oncology Group

Record History

The 50 most recent of 66 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Re-verified, no change to tracked fieldsv66
  2. Primary and study completion pushed from Dec 31, 2026 to Mar 31, 2027v65
  3. Study sites revised (205)v64 See this version in full on ClinicalTrials.gov ↗
  4. Study sites revised (205)v63 See this version in full on ClinicalTrials.gov ↗
  5. Re-verified, no change to tracked fieldsv62
Show 45 earlier versionsHide 45 earlier versions
  1. Study sites revised (205)v61 See this version in full on ClinicalTrials.gov ↗
  2. Study sites revised (205)v60 See this version in full on ClinicalTrials.gov ↗
  3. 3 versions Re-verified since Mar 18, 2025, no change to tracked fieldsv57-v59
  4. Study sites revised (205)v56 See this version in full on ClinicalTrials.gov ↗
  5. Primary and study completion dates: Jun 30, 2026 to Dec 31, 2026v55
  6. Study sites revised (205)v54 See this version in full on ClinicalTrials.gov ↗
  7. Phase: Phase 2/3 to Phase 3 Interventions: Carboplatin (Drug), Cisplatin (Drug), Doxorubicin (Drug), Etoposide (Drug), Fluorouracil (Drug), Gemcitabine (Drug), Irinotecan (Drug)… to Biospecimen Collection (Procedure), Carboplatin (Drug), Cisplatin (Drug), Doxorubicin (Drug), Etoposide (Drug), Fluorouracil (Drug)… · Study description expanded, about 8 words · Study sites revised (205)v53 Show 3 more changesShow less
    • Interventions: Carboplatin (Drug), Cisplatin (Drug), Doxorubicin (Drug), Etoposide (Drug), Fluorouracil (Drug), Gemcitabine (Drug), Irinotecan (Drug)… to Biospecimen Collection (Procedure), Carboplatin (Drug), Cisplatin (Drug), Doxorubicin (Drug), Etoposide (Drug), Fluorouracil (Drug)…
    • Study description expanded, about 8 words
    • Study sites revised (205)

    See this version in full on ClinicalTrials.gov ↗

  8. Re-verified, no change to tracked fieldsv52
  9. Study sites revised (205)v51 See this version in full on ClinicalTrials.gov ↗
  10. 2 versions Re-verified since Feb 27, 2024, no change to tracked fieldsv49-v50
  11. Trial status: Recruiting to Active, Not Recruiting Site details revised at 205 of 205 sitesv48 Show 1 more changeShow less
    • Site details revised at 205 of 205 sites
  12. Site details revised at 7 of 205 sitesv47
  13. Study sites: 204 to 205v46
  14. Primary and study completion dates: Jun 30, 2025 to Jun 30, 2026 Start date: May 23, 2018 to May 24, 2018 · Site details revised at 6 of 204 sitesv45 Show 2 more changesShow less
    • Start date: May 23, 2018 to May 24, 2018
    • Site details revised at 6 of 204 sites
  15. Site details revised at 5 of 204 sitesv44
  16. Site details revised at 6 of 204 sitesv43
  17. Study sites: 203 to 204v42
  18. Study sites: 202 to 203v41
  19. Site details revised at 3 of 202 sitesv40
  20. Study sites revised (202)v39 See this version in full on ClinicalTrials.gov ↗
  21. Study sites: 201 to 202v38
  22. Site details revised at 3 of 201 sitesv37
  23. Site details revised at 4 of 201 sitesv36
  24. Site details revised at 3 of 201 sitesv35
  25. Study sites: 200 to 201v34
  26. Interventions: Carboplatin (Drug), Cisplatin (Drug), Doxorubicin (Drug), Etoposide (Drug), Fluorouracil (Drug), Gemcitabine (Drug), Irinotecan (Drug)… to Carboplatin (Drug), Cisplatin (Drug), Doxorubicin (Drug), Etoposide (Drug), Fluorouracil (Drug), Gemcitabine (Drug), Irinotecan (Drug)…v33
  27. Site details revised at 8 of 200 sitesv32
  28. Study description expanded, about 46 words Site details revised at 12 of 200 sites · Study arms: 14 to 15v31 Show 2 more changesShow less
    • Site details revised at 12 of 200 sites
    • Study arms: 14 to 15

    See this version in full on ClinicalTrials.gov ↗

  29. Study sites revised (200)v30 See this version in full on ClinicalTrials.gov ↗
  30. Site details revised at 3 of 200 sitesv29
  31. Study sites: 199 to 200v28
  32. Enrollment target: 1220 to 537 Study sites: 197 to 199v27 Show 1 more changeShow less
    • Study sites: 197 to 199
  33. Site contacts updated at 4 of 197 sitesv26
  34. Study sites: 195 to 197v25
  35. Study sites: 194 to 195 Study description expanded, about 22 words · Eligibility criteria shortened, about 2 wordsv24 Show 2 more changesShow less
    • Study description expanded, about 22 words
    • Eligibility criteria shortened, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  36. Study sites: 192 to 194v23
  37. Study sites: 190 to 192v22
  38. Study sites: 184 to 190v21
  39. Study sites: 181 to 184v20
  40. Re-verified, no change to tracked fieldsv19
  41. Study sites: 177 to 181v18
  42. Study sites: 174 to 177v17
  • 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 partially randomized phase II/III trial studies how well, in combination with surgery, cisplatin and combination chemotherapy works in treating children and young adults with hepatoblastoma or hepatocellular carcinoma. Drugs used in chemotherapy, such as cisplatin, doxorubicin, fluorouracil, vincristine sulfate, carboplatin, etoposide, irinotecan, sorafenib, gemcitabine and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving combination chemotherapy may kill more tumor cells than one type of chemotherapy alone.
Trial Details
NCT Number NCT03533582
Lead Sponsor Children's Oncology Group
Collaborators: National Cancer Institute (NCI)
Conditions Childhood Hepatocellular Carcinoma, Childhood Malignant Liver Neoplasm, Fibrolamellar Carcinoma, Hepatoblastoma, Hepatocellular Malignant Neoplasm, Not Otherwise Specified
Enrollment 537 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov