Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
450 participants
INTERVENTIONAL
2017-08-24
2027-08-01
Brief Summary
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Children with HCC will be included as a separate cohort.
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Detailed Description
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Patients with HCC will be divided into groups based on whether the tumour is resectable or unresectable and/or metastatic.
Evaluation of the biology of HB and HCC, using the identification/validation of novel and already reported prognostic biomarkers as well as toxicity biomarkers is a key strand of this trial, so patients in all risk groups can be registered. The trial is also designed to optimise the collection of clinically annotated biologic specimens and establish the world's largest repository of blood and tissue samples from paediatric patients with HB and HCC.
The trial includes 4 randomised comparisons addressing therapeutic questions. For low risk HB patients, outcome with a total of 4 cycles of treatment is not inferior to those receiving a total of 6 cycles of treatment.
For intermediate risk patients, 3 regimens will be compared for outcome and toxicity.
For high risk patients, 2 post induction regimens will be compared for outcome. For resected HCC patients, the addition of GEMOX to PLADO regimen will be compared.
In addition the following will be assessed:
* To validate a new global risk stratification, defined by Children's Hepatic Tumours International Collaboration (CHIC)
* To evaluate clinically relevant factors, including the following:
* Provide a comprehensive and highly-validated panel of diagnostic and prognostic biomarkers
* Determine if paediatric HCC is a biologically different entity to adult HCC
* Develop genomic and/or biomarker analysis to predict children who may have an increased risk of developing toxicity with chemotherapy.
* To establish a collection of clinically and pathologically-annotated biological samples.
* Evaluate a surgical planning tool for an impact on decision making processes in POST-TEXT III and IV HB
Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
NONE
Study Groups
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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).
Cisplatin
Arms A and B - cisplatin is used alone Arms C, D, E and F - cisplatin us used in combination
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.
Cisplatin
Arms A and B - cisplatin is used alone Arms C, D, E and F - cisplatin us used in combination
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)
Cisplatin
Arms A and B - cisplatin is used alone Arms C, D, E and F - cisplatin us used in combination
Doxorubicin
Arms C, D and E used in combination
Carboplatin
Arms C and D used in combination
5Fluorouracil
Arm C used alone
Vincristine
Arms C and D used in combination
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).
Cisplatin
Arms A and B - cisplatin is used alone Arms C, D, E and F - cisplatin us used in combination
Doxorubicin
Arms C, D and E used in combination
Carboplatin
Arms C and D used in combination
Vincristine
Arms C and D used in combination
Etoposide
Arm D used in combination
Irinotecan
Arm D used in combination
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.
Cisplatin
Arms A and B - cisplatin is used alone Arms C, D, E and F - cisplatin us used in combination
Doxorubicin
Arms C, D and E used in combination
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)
Cisplatin
Arms A and B - cisplatin is used alone Arms C, D, E and F - cisplatin us used in combination
Doxorubicin
Arms C, D and E used in combination
Gemcitabine
Arm F used in combination
Oxaliplatin
Arm F used in combination
Sorafenib
Arm used in combination
Interventions
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Cisplatin
Arms A and B - cisplatin is used alone Arms C, D, E and F - cisplatin us used in combination
Doxorubicin
Arms C, D and E used in combination
Carboplatin
Arms C and D used in combination
5Fluorouracil
Arm C used alone
Vincristine
Arms C and D used in combination
Etoposide
Arm D used in combination
Irinotecan
Arm D used in combination
Gemcitabine
Arm F used in combination
Oxaliplatin
Arm F used in combination
Sorafenib
Arm used in combination
Eligibility Criteria
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Inclusion Criteria
\*Histological confirmation of HB is required except in emergency situations where:
* a) the patient meets all other eligibility criteria, but is too ill to undergo a biopsy safely, the patient may be enrolled without a biopsy.
* b) there is anatomic or mechanical compromise of critical organ function by tumour (e.g., respiratory distress/failure, abdominal compartment syndrome, urinary obstruction, etc.)
* c) Uncorrectable coagulopathy
* Age ≤30 years
* Written informed consent for trial entry
Exclusion Criteria
* Recurrent disease
* Previously received a solid organ transplant; other than orthotopic liver transplantation (OLT).
* Uncontrolled infection
* Unable to follow or comply with the protocol for any reason
* Second malignancy
* Pregnant or breastfeeding women
30 Years
ALL
No
Sponsors
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Fundació Institut Germans Trias i Pujol
OTHER
University Hospital Munich
OTHER
University Hospital, Bonn
OTHER
University of Kiel
OTHER
University Hospital Tuebingen
OTHER
University of Padova
OTHER
Ludwig-Maximilians - University of Munich
OTHER
Medical University of Gdansk
OTHER
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
OTHER
Motol University Hospital
OTHER
Rennes University Hospital
OTHER
Children's University Hospital, Ireland
OTHER
University of Oslo
OTHER
Princess Maxima Center for Pediatric Oncology
OTHER
Andaluz Health Service
OTHER_GOV
Swiss Pediatric Oncology Group
OTHER
Gothia Forum - Center for Clinical Trial
OTHER
The Leeds Teaching Hospitals NHS Trust
OTHER
Bambino Gesù Hospital and Research Institute
OTHER
Newcastle University Centre for Cancer, Newcastle
UNKNOWN
Experimental Cancer Medicine Centres
OTHER
XenTech, Evry
UNKNOWN
University of Birmingham
OTHER
Responsible Party
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Principal Investigators
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Madhumita Dandapani, MD PhD
Role: PRINCIPAL_INVESTIGATOR
University of Nottingham
Marc Ansari, MD
Role: PRINCIPAL_INVESTIGATOR
University of Geneva
Locations
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St. Anna Kinderspital
Vienna, , Austria
Cliniques Universitaires Saint-Luc
Brussels, Woluwe-Saint-Lambert, Belgium
University Hospital Motol
Prague, , Czechia
Kuopio University Hospital
Kuopio, , Finland
CHU de Rennes
Rennes, , France
Ludwig-Maximillians-University Munich
Munich, , Germany
Children's Health Ireland Crumlin
Dublin, , Ireland
Schneider Children's Medical Center
Petah Tikva, , Israel
Prinses Maxima Center
Utrecht, , Netherlands
Oslo University Hospital
Nydalen, , Norway
Medical University of Gdansk
Gdansk, , Poland
University Hospital Reina Sofia
Córdoba, , Spain
Hopitaux Universitaires de Geneve
Geneva, , Switzerland
Royal Aberdeen Children's Hospital
Aberdeen, , United Kingdom
Royal Belfast Hospital for Sick Children
Belfast, , United Kingdom
Birmingham Children's Hospital
Birmingham, , United Kingdom
Bristol Royal Hospital for Children
Bristol, , United Kingdom
Addenbrooke's Hospital
Cambridge, , United Kingdom
Noah's Ark Children's Hospital for Wales
Cardiff, , United Kingdom
Royal Hospital for Children
Edinburgh, , United Kingdom
Royal Hospital for Children
Glasgow, , United Kingdom
Leeds General Infirmary
Leeds, , United Kingdom
Leicester Royal Infirmary
Leicester, , United Kingdom
Alder Hey Children's Hospital
Liverpool, , United Kingdom
Great Ormond Street Hospital
London, , United Kingdom
Royal Manchester Children's Hospital
Manchester, , United Kingdom
Great North Children's Hospital
Newcastle upon Tyne, , United Kingdom
Nottingham Children's Hospital
Nottingham, , United Kingdom
Oxford Children's Hospital
Oxford, , United Kingdom
Sheffield Children's Hospital
Sheffield, , United Kingdom
University Hospital Southampton
Southampton, , United Kingdom
The Royal Marsden Hospital
Sutton, , United Kingdom
Countries
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Other Identifiers
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RG_15-114
Identifier Type: -
Identifier Source: org_study_id
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