We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Chemotherapy in Treating Children With Liver Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00003912
First Posted: January 27, 2003
Last Update Posted: December 4, 2013
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.
Information provided by:
National Cancer Institute (NCI)
  Purpose

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 Intervention Phase
Liver Cancer Drug: carboplatin Drug: cisplatin Drug: doxorubicin hydrochloride Procedure: conventional surgery Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
Official Title: Liver Tumour Studies - Hepatoblastoma and Hepatocellular Carcinoma

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Tumor response
  • Complete resection rate
  • Overall survival
  • Event-free survival
  • Toxicity
  • Response rate
  • Resection rate

Estimated Enrollment: 260
Study Start Date: June 1998
Study Completion Date: October 2009
  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age:

  • 16 and under at diagnosis

Performance status:

  • Not specified

Life expectancy:

  • Not specified

Hematopoietic:

  • Not specified

Hepatic:

  • Not specified

Renal:

  • Not specified

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • Not specified

Endocrine therapy:

  • Not specified

Radiotherapy:

  • Not specified

Surgery:

  • See Disease Characteristics
  • Prior surgery allowed
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00003912


Locations
Italy
Azienda Ospedaliera di Padova
Padova, Italy, 35128
Sponsors and Collaborators
Societe Internationale d'Oncologie Pediatrique
Investigators
Study Chair: Giorgio Perilongo, MD Azienda Ospedaliera di Padova
  More Information

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 ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00003912     History of Changes
Other Study ID Numbers: CDR0000067091
SIOP-SIOPEL-3
EU-98067
UKCCSG-LT-1998-01
First Submitted: November 1, 1999
First Posted: January 27, 2003
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:
Carcinoma, Hepatocellular
Liver Neoplasms
Hepatoblastoma
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Neoplasms, Complex and Mixed
Liposomal doxorubicin
Carboplatin
Doxorubicin
Antineoplastic Agents
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action