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Chemotherapy in Treating Children With Liver Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00003912
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : December 4, 2013
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which chemotherapy regimen is more effective in treating children with liver cancer.

PURPOSE: Randomized phase III trial to study the effectiveness of cisplatin with or without doxorubicin and the effectiveness of combining cisplatin, carboplatin, and doxorubicin in treating children who have liver cancer.

Condition or disease Intervention/treatment Phase
Liver Cancer Drug: carboplatin Drug: cisplatin Drug: doxorubicin hydrochloride Procedure: conventional surgery Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 260 participants
Allocation: Randomized
Primary Purpose: Treatment
Official Title: Liver Tumour Studies - Hepatoblastoma and Hepatocellular Carcinoma
Study Start Date : June 1998
Actual Study Completion Date : October 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Liver Cancer

Primary Outcome Measures :
  1. Tumor response
  2. Complete resection rate
  3. Overall survival
  4. Event-free survival
  5. Toxicity
  6. Response rate
  7. Resection rate

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically proven hepatoblastoma or hepatocellular carcinoma

    • Diagnostic surgical biopsy strongly recommended for all patients and mandatory for the following:

      • Children under 6 months of age
      • Children over 3 years of age
      • Patients with a normal serum alfa-fetoprotein (alfa-FP)
    • Compatible imaging and raised serum alfa-FP level mandatory if no biopsy performed
  • Standard risk disease:

    • Tumors involving no more than 3 hepatic sections
    • No extrahepatic abdominal disease
    • No metastases
  • High risk disease:

    • Tumors involving all 4 hepatic sections AND/OR
    • Evidence of extrahepatic metastases or abdominal disease
  • Presence or absence of metastatic disease must be documented by chest x-ray and/or lung CT scan



  • 16 and under at diagnosis

Performance status:

  • Not specified

Life expectancy:

  • Not specified


  • Not specified


  • Not specified


  • Not specified


Biologic therapy:

  • Not specified


  • Not specified

Endocrine therapy:

  • Not specified


  • Not specified


  • See Disease Characteristics
  • Prior surgery allowed

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00003912

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Azienda Ospedaliera di Padova
Padova, Italy, 35128
Sponsors and Collaborators
Societe Internationale d'Oncologie Pediatrique
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Study Chair: Giorgio Perilongo, MD Azienda Ospedaliera di Padova
Publications of Results:
Other Publications:
Brock P, Shafford E, Brugieres L, et al.: Metastatic hepatoblastoma (HB) treated with a dose intensive multiagent chemotherapy regimen, results from the second study of the Childhood Liver Tumour Strategy Group of the International Society of Pediatric Oncology- SIOPEL 2. [Abstract] Proceedings of the American Society of Clinical Oncology 21: A-1603, 2002.
Perilongo G, Shafford E, Brugieres L, et al.: Cisplatin (CDDP) alone and delayed surgery, an effective treatment for standard risk (SR) hepatoblastoma (HB), the most relevant finding of the SIOPEL2. [Abstract] Proceedings of the American Society of Clinical Oncology 21: A-1571, 2002.

Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00003912    
Other Study ID Numbers: CDR0000067091
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: December 4, 2013
Last Verified: December 2000
Keywords provided by National Cancer Institute (NCI):
stage I childhood liver cancer
stage II childhood liver cancer
stage III childhood liver cancer
stage IV childhood liver cancer
recurrent childhood liver cancer
childhood hepatoblastoma
childhood hepatocellular carcinoma
Additional relevant MeSH terms:
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Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Neoplasms, Complex and Mixed
Neoplasms by Histologic Type
Liposomal doxorubicin
Antineoplastic Agents
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action