Clinical Trial: Chemotherapy in Treating Children With Liver Cancer

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Liver Tumour Studies - Hepatoblastoma and Hepatocellular Carcinoma

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.

Detailed Summary:

OBJECTIVES:

• Compare the efficacy of cisplatin with or without doxorubicin in terms of tumor response, complete resection rate, overall survival, and event free survival in children with standard risk hepatoblastoma.
• Compare the toxicity of cisplatin with or without doxorubicin in this patient population.
• Evaluate whether an intensive multiagent regimen including carboplatin, cisplatin, and doxorubicin improves the response rate to chemotherapy and subsequent resection rate of children with high risk hepatoblastoma or hepatocellular carcinoma.

OUTLINE: This is a randomized, multicenter study. All hepatoblastoma patients are intended to be treated with primary chemotherapy. Hepatoblastoma patients are stratified by risk (standard vs high).

Patients receive cisplatin IV over 24 hours on day 1, beginning within 15 days of diagnosis. Standard risk patients are then randomized to one of two treatment arms. High risk hepatoblastoma patients and hepatocellular carcinoma patients receive a separate multiagent regimen.

• Arm I: Patients receive cisplatin IV over 24 hours and doxorubicin IV over 48 hours beginning on day 15. Treatment repeats every 21 days for a maximum of 5 courses. Tumor response is evaluated prior to the second course. Patients with responsive disease receive the remaining 2 courses of the preoperative phase, then undergo delayed primary surgery if their tumors are deemed resectable, prior to receiving 2 additional courses of chemotherapy. Patients whose tumors are still unresectable after 3 courses receive 2 more courses of chemotherapy, then undergo surgery if feasible. Patient
  Sponsor: Societe Internationale d'Oncologie Pediatrique
  

  Current Primary Outcome:

  • Tumor response
  • Complete resection rate
  • Overall survival
  • Event-free survival
  • Toxicity
  • Response rate
  • Resection rate
  
  
  

  Original Primary Outcome:
  
  

  Current Secondary Outcome:
  
  

  Original Secondary Outcome:
  
  Information By: National Cancer Institute (NCI)
  

  Dates:
  Date Received: November 1, 1999
  Date Started: June 1998
  Date Completion:
  Last Updated: December 3, 2013
  Last Verified: December 2000