Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00025428
Status:
COMPLETED
Last Update Posted:
2013-12-04
First Post:
2001-10-11
Brief Title:
Combination Chemotherapy Before Surgery in Treating Children With Localized Neuroblastoma
Sponsor:
Societe Internationale dOncologie Pediatrique
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Treatment Of Children Over The Age Of 1 Year With Unresectable Localized Neuroblastoma Without MYCN Amplification
Status:
COMPLETED
Status Verified Date:
2006-11
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 Giving chemotherapy drugs before surgery may shrink the tumor so that it can be removed during surgery
PURPOSE Phase III trial to determine the effectiveness of combination chemotherapy given before surgery in treating children who have localized neuroblastoma
PURPOSE Phase III trial to determine the effectiveness of combination chemotherapy given before surgery in treating children who have localized neuroblastoma
Detailed Description:
OBJECTIVES
Determine the outcome in terms of local control event-free survival and overall survival of children with localized unresectable neuroblastoma without MYCN amplification treated with carboplatin etoposide cyclophosphamide doxorubicin and vincristine followed by surgery
OUTLINE This is a multicenter study
Patients receive carboplatin IV over 1 hour and etoposide IV over 2 hours on days 1-3 courses 1 and 3 Patients receive cyclophosphamide IV over 1 hour on days 1-5 or orally on days 2 and 3 doxorubicin IV over 6 hours on days 4-5 and vincristine IV on days 1 and 5 courses 2 and 4 Treatment repeats every 21 days for 4 courses Patients then undergo surgical resection followed by 2 additional courses of chemotherapy
Patients are followed at months 8 10 12 16 20 24 30 36 42 48 and 60
PROJECTED ACCRUAL A total of 100 patients will be accrued for this study within 4 years
Determine the outcome in terms of local control event-free survival and overall survival of children with localized unresectable neuroblastoma without MYCN amplification treated with carboplatin etoposide cyclophosphamide doxorubicin and vincristine followed by surgery
OUTLINE This is a multicenter study
Patients receive carboplatin IV over 1 hour and etoposide IV over 2 hours on days 1-3 courses 1 and 3 Patients receive cyclophosphamide IV over 1 hour on days 1-5 or orally on days 2 and 3 doxorubicin IV over 6 hours on days 4-5 and vincristine IV on days 1 and 5 courses 2 and 4 Treatment repeats every 21 days for 4 courses Patients then undergo surgical resection followed by 2 additional courses of chemotherapy
Patients are followed at months 8 10 12 16 20 24 30 36 42 48 and 60
PROJECTED ACCRUAL A total of 100 patients will be accrued for this study within 4 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 |
|---|---|---|---|
| EU-20107 | None | None | None |
| SIOP-NB-2009 | None | None | None |
| CCLG-NB-2000-09 | None | None | None |