Chemotherapy in Treating Children With Liver Cancer

• Status: Completed
• Trial end date: 2009-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Societe Internationale d'Oncologie Pediatrique
• Treatments: Carboplatin; Doxorubicin; Liposomal doxorubicin

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