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Sponsored by: |
Societe Internationale d'Oncologie Pediatrique |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00003912 |
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 III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Active Control |
Official Title: | Liver Tumour Studies - Hepatoblastoma and Hepatocellular Carcinoma |
Estimated Enrollment: | 260 |
Study Start Date: | June 1998 |
Ages Eligible for Study: | up to 16 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically proven hepatoblastoma or hepatocellular carcinoma
Diagnostic surgical biopsy strongly recommended for all patients and mandatory for the following:
Standard risk disease:
High risk disease:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Study ID Numbers: | CDR0000067091, SIOP-SIOPEL-3, EU-98067, UKCCSG-LT-1998-01 |
Study First Received: | November 1, 1999 |
Last Updated: | May 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00003912 |
Health Authority: | United States: Federal Government |
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 |
Liver Diseases Digestive System Neoplasms Carcinoma, Hepatocellular Liver neoplasms Carboplatin Doxorubicin Recurrence Carcinoma |
Liver Neoplasms Digestive System Diseases Cisplatin Gastrointestinal Neoplasms Hepatoblastoma Adenocarcinoma Neoplasms, Glandular and Epithelial Hepatocellular carcinoma |
Neoplasms Neoplasms by Site Neoplasms by Histologic Type Antineoplastic Agents |
Therapeutic Uses Antibiotics, Antineoplastic Pharmacologic Actions Neoplasms, Complex and Mixed |