Ignite Creation Date:
2025-12-24 @ 1:17 PM
Ignite Modification Date:
2026-01-03 @ 2:55 AM
Study NCT ID:
NCT00162695
Status:
TERMINATED
Last Update Posted:
2005-09-13
First Post:
2005-09-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Rhabdomyosarcoma and Malignant Soft Tissue Tumours of Childhood
Sponsor:
Gustave Roussy, Cancer Campus, Grand Paris
Organization:
Study Overview
Official Title:
None
Status:
TERMINATED
Status Verified Date:
2005-09
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:
Objective of the study objectives was to explore survival advantage for an intensified chemotherapy strategy in a randomised trial.
IVA (ifosfamide, vincristine, actinomycin D) or a 6 drug combination (IVA + carboplatin, epirubicin, etoposide) both delivered over 27 weeks. Cumulative dose / m2 = ifosfamide 54g (both arms), epirubicin 450 mg, etoposide 1350 mg (6 drug). Delivery of radiotherapy was determined according to site and / or response to chemotherapy ± surgery.
The study was powered to detect 10% difference in 3 year OS.
IVA (ifosfamide, vincristine, actinomycin D) or a 6 drug combination (IVA + carboplatin, epirubicin, etoposide) both delivered over 27 weeks. Cumulative dose / m2 = ifosfamide 54g (both arms), epirubicin 450 mg, etoposide 1350 mg (6 drug). Delivery of radiotherapy was determined according to site and / or response to chemotherapy ± surgery.
The study was powered to detect 10% difference in 3 year OS.
Detailed Description:
None
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?: