Chemotherapy in Treating Children With Liver Cancer
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|ClinicalTrials.gov Identifier: NCT00003912|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : December 4, 2013
|First Submitted Date ICMJE||November 1, 1999|
|First Posted Date ICMJE||January 27, 2003|
|Last Update Posted Date||December 4, 2013|
|Study Start Date ICMJE||June 1998|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00003912 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Chemotherapy in Treating Children With Liver Cancer|
|Official Title ICMJE||Liver Tumour Studies - Hepatoblastoma and Hepatocellular Carcinoma|
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.
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.
Patients with high risk hepatoblastoma or unresectable hepatocellular carcinoma receive cisplatin IV over 24 hours on days 29, 57, and 85, and carboplatin IV over 1 hour followed by doxorubicin IV over 48 hours on days 15, 43, and 71. Patients with responsive resectable disease undergo surgery either after day 43 or within 3 weeks of day 85 of preoperative chemotherapy, then receive another 2 courses of carboplatin and doxorubicin on days 1 and 29 post surgery, and one more course of cisplatin on day 15 post surgery, for a total of 5 courses each. Patients with responsive but unresectable disease after day 85 also receive 2 more courses of carboplatin and doxorubicin alternating with 1 course of cisplatin. Definitive surgery will be re-considered after these further courses of chemotherapy. Patients with stable disease at day 43 or a tumor that remains unresectable after completion of chemotherapy may be considered for liver transplant.
Patients with a resectable hepatocellular carcinoma have primary surgery followed by alternating courses of cisplatin, and carboplatin and doxorubicin for a total of 4 courses of cisplatin and 3 courses of carboplatin and doxorubicin.
Patients are followed every 2-3 months for 2 years, every 6 months for 1 year, then annually thereafter.
PROJECTED ACCRUAL: A total of 170-260 patients (85-130 patients per treatment arm) will be accrued for this study over 5.5 years.
|Study Type ICMJE||Interventional|
|Study Phase||Phase 3|
|Study Design ICMJE||Allocation: Randomized
Primary Purpose: Treatment
|Condition ICMJE||Liver Cancer|
|Study Arms||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Estimated Enrollment ICMJE
|Original Enrollment ICMJE||Not Provided|
|Actual Study Completion Date||October 2009|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
PRIOR CONCURRENT THERAPY:
|Ages||up to 16 Years (Child)|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||Italy|
|Removed Location Countries|
|NCT Number ICMJE||NCT00003912|
|Other Study ID Numbers ICMJE||CDR0000067091
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||Societe Internationale d'Oncologie Pediatrique|
|Collaborators ICMJE||Not Provided|
|PRS Account||National Cancer Institute (NCI)|
|Verification Date||December 2000|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP