Ignite Creation Date:
2024-05-05 @ 9:36 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003912
Status:
COMPLETED
Last Update Posted:
2013-12-04
First Post:
1999-11-01
Brief Title:
Chemotherapy in Treating Children With Liver Cancer
Sponsor:
Societe Internationale dOncologie Pediatrique
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Liver Tumour Studies - Hepatoblastoma and Hepatocellular Carcinoma
Status:
COMPLETED
Status Verified Date:
2000-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Description:
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 Patients with stable disease are considered for radical surgery or salvage chemotherapy Patients with unresectable tumors after 5 courses may be considered for liver transplant or salvage chemotherapy
Arm II Patients receive cisplatin IV over 24 hours every 15 days for a maximum of 5 additional courses Tumor response is evaluated after the second course Patients with responsive disease receive another 2 courses of cisplatin Patients with resectable tumors after 4 courses undergo delayed primary surgery then receive 2 more courses of cisplatin Patients whose tumors are still unresectable after 4 courses receive 2 more courses of cisplatin then undergo surgery if their tumors are resectable Patients with stable disease may be moved to the high risk regimen or considered for radical surgery Patients with unresectable tumors after 6 courses may be considered for liver transplant or salvage chemotherapy
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 55 years
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 Patients with stable disease are considered for radical surgery or salvage chemotherapy Patients with unresectable tumors after 5 courses may be considered for liver transplant or salvage chemotherapy
Arm II Patients receive cisplatin IV over 24 hours every 15 days for a maximum of 5 additional courses Tumor response is evaluated after the second course Patients with responsive disease receive another 2 courses of cisplatin Patients with resectable tumors after 4 courses undergo delayed primary surgery then receive 2 more courses of cisplatin Patients whose tumors are still unresectable after 4 courses receive 2 more courses of cisplatin then undergo surgery if their tumors are resectable Patients with stable disease may be moved to the high risk regimen or considered for radical surgery Patients with unresectable tumors after 6 courses may be considered for liver transplant or salvage chemotherapy
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 55 years
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| UKCCSG-LT-1998-01 | None | None | None |
| EU-98067 | None | None | None |
| SIOP-SIOPEL-3 | None | None | None |