Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003212
Status:
COMPLETED
Last Update Posted:
2012-01-20
First Post:
1999-11-01
Brief Title:
Ifosfamide or Doxorubicin in Treating Patients With Advanced or Metastatic Soft Tissue Sarcoma
Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Organization:
European Organisation for Research and Treatment of Cancer - EORTC
Study Overview
Official Title:
Randomized Phase III Trial of Two Investigational Schedules of Ifosfamide vs Standard Dose Doxorubicin in Patients With Advanced or Metastatic Soft Tissue Sarcoma
Status:
COMPLETED
Status Verified Date:
2012-01
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 whether ifosfamide or doxorubicin is more effective for advanced or metastatic soft tissue sarcoma
PURPOSE Randomized phase III trial to compare the effectiveness of ifosfamide with that of doxorubicin in treating patients who have advanced or metastatic soft tissue sarcoma
PURPOSE Randomized phase III trial to compare the effectiveness of ifosfamide with that of doxorubicin in treating patients who have advanced or metastatic soft tissue sarcoma
Detailed Description:
OBJECTIVES I Determine the progression free survival rate in patients with advanced or metastatic soft tissue sarcoma treated with either of two different regimens of ifosfamide or doxorubicin II Assess the toxic effects of these therapies and response rate in these patients
OUTLINE This is a randomized multicenter study Patients are randomized into one of 3 arms continuous ifosfamide ifosfamide daily for 3 days or doxorubicin Patients are stratified by performance status 0 vs 1 liver involvement no vs yes histological type leiomyosarcoma vs synovial sarcoma vs other and histological grade 1 vs 2 vs 3 Arm I Patients receive doxorubicin by bolus infusion for 5-20 minutes once every 3 weeks Arm II Patients receive ifosfamide by intravenous infusion for 4 hours on days 1 2 and 3 every three weeks Arm III Patients receive ifosfamide by intravenous infusion for 72 hours every 3 weeks Patients are assessed after every 2 courses of therapy Each course of therapy consists of 3 weeks of treatment Patients may receive a maximum of 6 courses of therapy in the absence of toxicity and disease progression Patients are followed every 12 weeks for survival
PROJECTED ACCRUAL A total of 780 patients 260 per treatment arm will be accrued for this study
OUTLINE This is a randomized multicenter study Patients are randomized into one of 3 arms continuous ifosfamide ifosfamide daily for 3 days or doxorubicin Patients are stratified by performance status 0 vs 1 liver involvement no vs yes histological type leiomyosarcoma vs synovial sarcoma vs other and histological grade 1 vs 2 vs 3 Arm I Patients receive doxorubicin by bolus infusion for 5-20 minutes once every 3 weeks Arm II Patients receive ifosfamide by intravenous infusion for 4 hours on days 1 2 and 3 every three weeks Arm III Patients receive ifosfamide by intravenous infusion for 72 hours every 3 weeks Patients are assessed after every 2 courses of therapy Each course of therapy consists of 3 weeks of treatment Patients may receive a maximum of 6 courses of therapy in the absence of toxicity and disease progression Patients are followed every 12 weeks for survival
PROJECTED ACCRUAL A total of 780 patients 260 per treatment arm will be accrued for this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EORTC-62971 | None | None | None |