Ignite Creation Date:
2024-05-05 @ 11:32 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00077389
Status:
UNKNOWN
Last Update Posted:
2014-06-24
First Post:
2004-02-10
Brief Title:
Intensive Neoadjuvant Chemotherapy in Treating Young Patients Undergoing Surgical Resection for High-Risk Hepatoblastoma
Sponsor:
University of Leicester
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Intensified Pre-Operative Chemotherapy And Radical Surgery For High Risk Hepatoblastoma
Status:
UNKNOWN
Status Verified Date:
2009-12
Last Known Status:
ACTIVE_NOT_RECRUITING
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 work in different ways to stop tumor cells from dividing so they stop growing or die Giving chemotherapy drugs before surgery may shrink the tumor so that it can be removed
PURPOSE This phase II trial is studying how well neoadjuvant chemotherapy works in treating young patients who are undergoing surgical resection for high-risk hepatoblastoma
PURPOSE This phase II trial is studying how well neoadjuvant chemotherapy works in treating young patients who are undergoing surgical resection for high-risk hepatoblastoma
Detailed Description:
OBJECTIVES
Primary
Determine the efficacy and short-term toxicity of intensified neoadjuvant chemotherapy in children with high-risk hepatoblastoma undergoing surgical resection
Increase the rate of complete surgical resection in these patients by fully implementing liver transplantation as a valid treatment option for tumor removal when partial liver resection or other surgical options remain unfeasible even after extensive preoperative chemotherapy
Determine prospectively the role of this regimen in rendering unresectable tumors resectable in these patients
Determine the accuracy of initial imaging in predicting the surgical options after treatment with this regimen for patients presenting with unresectable disease
Secondary
Determine the overall survival and event-free survival of patients treated with this regimen with an acceptable overall toxicity
Determine the toxicity of this regimen in these patients
Determine the response rate in patients treated with this regimen
Determine whether response to this regimen defined by the modified RECIST criteria can be used for better monitoring of response in these patients
Determine whether a fall in alpha-fetoprotein during this neoadjuvant regimen can be used as a prognostic factor in these patients
Determine prospectively radiological surgical and pathological characteristics of the tumor that might identify possible novel factors that might influence treatment choice and outcome in these patients
OUTLINE This is an open-label multicenter study
Intensified neoadjuvant chemotherapy Patients receive cisplatin IV over 24 hours on days 1 8 15 29 36 43 57 and 64 and doxorubicin IV over 1 hour OR over 24 hours on days 8 9 36 37 57 and 58 Patients determined to have resectable disease proceed to surgery
Patients determined to have unresectable disease after neoadjuvant chemotherapy receive additional neoadjuvant chemotherapy comprising carboplatin IV over 1 hour on days 1 and 22 and doxorubicin IV over 1 hour OR over 24 hours on days 1 2 3 22 23 and 24
Treatment continues in the absence of unacceptable toxicity
Surgery Patients determined to have resectable disease undergo complete resection and possibly liver transplantation
Adjuvant chemotherapy Patients who undergo complete surgical resection receive carboplatin IV over 1 hour on day 1 and doxorubicin IV over 1 hour OR over 24 hours on days 1 and 2 Treatment repeats every 3 weeks for a total of 3 courses
NOTE Patients who received additional neoadjuvant chemotherapy for unresectable disease do not receive adjuvant chemotherapy
Patients are followed every 2-3 months for 2 years every 3 months for 1 year and then every 6 months for 2 years
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL A total of 23-57 patients will be accrued for this study within 2 years
Primary
Determine the efficacy and short-term toxicity of intensified neoadjuvant chemotherapy in children with high-risk hepatoblastoma undergoing surgical resection
Increase the rate of complete surgical resection in these patients by fully implementing liver transplantation as a valid treatment option for tumor removal when partial liver resection or other surgical options remain unfeasible even after extensive preoperative chemotherapy
Determine prospectively the role of this regimen in rendering unresectable tumors resectable in these patients
Determine the accuracy of initial imaging in predicting the surgical options after treatment with this regimen for patients presenting with unresectable disease
Secondary
Determine the overall survival and event-free survival of patients treated with this regimen with an acceptable overall toxicity
Determine the toxicity of this regimen in these patients
Determine the response rate in patients treated with this regimen
Determine whether response to this regimen defined by the modified RECIST criteria can be used for better monitoring of response in these patients
Determine whether a fall in alpha-fetoprotein during this neoadjuvant regimen can be used as a prognostic factor in these patients
Determine prospectively radiological surgical and pathological characteristics of the tumor that might identify possible novel factors that might influence treatment choice and outcome in these patients
OUTLINE This is an open-label multicenter study
Intensified neoadjuvant chemotherapy Patients receive cisplatin IV over 24 hours on days 1 8 15 29 36 43 57 and 64 and doxorubicin IV over 1 hour OR over 24 hours on days 8 9 36 37 57 and 58 Patients determined to have resectable disease proceed to surgery
Patients determined to have unresectable disease after neoadjuvant chemotherapy receive additional neoadjuvant chemotherapy comprising carboplatin IV over 1 hour on days 1 and 22 and doxorubicin IV over 1 hour OR over 24 hours on days 1 2 3 22 23 and 24
Treatment continues in the absence of unacceptable toxicity
Surgery Patients determined to have resectable disease undergo complete resection and possibly liver transplantation
Adjuvant chemotherapy Patients who undergo complete surgical resection receive carboplatin IV over 1 hour on day 1 and doxorubicin IV over 1 hour OR over 24 hours on days 1 and 2 Treatment repeats every 3 weeks for a total of 3 courses
NOTE Patients who received additional neoadjuvant chemotherapy for unresectable disease do not receive adjuvant chemotherapy
Patients are followed every 2-3 months for 2 years every 3 months for 1 year and then every 6 months for 2 years
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL A total of 23-57 patients will be accrued for this study within 2 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 |
|---|---|---|---|
| CCLG-LT-2004-09 | None | None | None |
| SIOP-SIOPEL-4 | None | None | None |
| EU-20336 | None | None | None |