Paediatric Hepatic International Tumour Trial

Sponsor
University of Birmingham
Study ID
NCT03017326
Phase
PHASE3
Status
Active Not Recruiting

Conditions

  • Carcinoma, Hepatocellular
  • Hepatoblastoma

Eligibility Criteria

Sex
ALL
Age
N/A - 30 Years
Healthy Volunteers
Not accepted

Interventions

  • Cisplatin — DRUG
    Arms A and B - cisplatin is used alone Arms C, D, E and F - cisplatin us used in combination
  • Doxorubicin — DRUG
    Arms C, D and E used in combination
  • Carboplatin — DRUG
    Arms C and D used in combination
  • 5Fluorouracil — DRUG
    Arm C used alone
  • Vincristine — DRUG
    Arms C and D used in combination
  • Etoposide — DRUG
    Arm D used in combination
  • Irinotecan — DRUG
    Arm D used in combination
  • Gemcitabine — DRUG
    Arm F used in combination
  • Oxaliplatin — DRUG
    Arm F used in combination
  • Sorafenib — DRUG
    Arm used in combination

Study Details

The PHITT trial is an over-arching study for patients with Hepatoblastoma (HB) and Hepatocellular Carcinoma (HCC). This trial will use a risk-adapted approach to the treatment of children diagnosed with HB. Children with HCC will be included as a separate cohort.

Key Dates

Start date
Aug 24, 2017
Status verified
May 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2027

Study Design

Enrollment
450 participants (estimated)
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT

Arms

  • Other: Group A Very Low Risk HB
    Patients with well differentiated foetal histology will receive 2 cycles of Cisplatin (2x 100mg/m2). Patients will non-well differentiated histology will be followed up only (no intervention).
  • Active Comparator: Group B Low Risk HB
    Patients who are resected after 2 cycles of Cisplatin will be randomised to receive 4 or 6 cycles of Cisplatin overall (80mg/m2). Patients who are not resected will continue to receive up to 6 cycles of Cisplatin (80mg/m2) until resection.
  • Active Comparator: Group C Intermediate Risk HB
    Patients will be randomised to receive Cisplatin (80mg/m2), Carboplatin (500mg/m2) and Doxorubicin (60mg/m2) as SIOPEL-3HR (5 cycles), Cisplatin (100mg/m2), Doxorubicin (60mg/m2) 5-Fluorouracil (600mg/m2) and Vincristine (4.5mg/m2) as C5VD (6 cycles), or 6 cycles of high dose Cisplatin (100mg/m2)
  • Active Comparator: Group D High Risk HB
    Patients will receive SIOPEL-4 regimen (Cisplatin 70mg/m2, Doxorubicin 30mg/m2) then have surgery. Post surgery, patients with remaining metastases will be randomised to receive 6 cycles of either Carboplatin (500mg/m2) and Doxorubicin (40mg/m2) alternating with Carboplatin (800mg/m2) and Etoposide (400mg/m2), or Carboplatin (500mg/m2) and Doxorubicin (40mg/m2) alternating with Vincristine (3mg/m2) and Irinotecan (250mg/m2). Patients with no metastases will receive the standard treatment of 3 cycles of Carboplatin (500mg/m2) and Doxorubicin (40mg/m2).
  • Other: Group E Resected HCC
    Patients with an underlying predisposition to HCC through genetic, viral or metabolic conditions will be followed up (no intervention). De novo or fibrolamellar HCC patients will receive 4 cycles of PLADO regimen (Cisplatin (80mg/m2) and Doxorubicin (60mg/m2)) over 4 cycles.
  • Active Comparator: Group F Unresected HCC
    Patients will be randomised to receive up to 6 cycles of PLADO (Cisplatin 80mg/m2, Doxorubicin 60mg/m2) with Sorafenib (300mg/m2) or up to 8 cycles of PLADO with Sorafenib and GEMOX (Gemcitabine 1000mg/m2, Oxaliplatin 100mg/m2) with Sorafenib (300mg/m2)

Primary Outcome Measure

Event-free survival (EFS) [ Time Frame: From date of randomisation (or registration into the trial for non-randomised patients), until date of first failure event, assessed up to 6 years. ]

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