Ignite Creation Date:
2024-05-05 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00061984
Status:
COMPLETED
Last Update Posted:
2014-10-27
First Post:
2003-06-05
Brief Title:
Doxorubicin With or Without Ifosfamide and Pegfilgrastim in Treating Patients With Locally 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:
Randomised Trial Of Single Agent Doxorubicin Versus Doxorubicin Plus Ifosfamide In The First Line Treatment Of Advanced Or Metastatic Soft Tissue Sarcoma
Status:
COMPLETED
Status Verified Date:
2014-10
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 such as doxorubicin and ifosfamide use different ways to stop tumor cells from dividing so they stop growing or die Colony-stimulating factors such as pegfilgrastim cause the body to make blood cells It is not yet known whether doxorubicin alone is more effective with or without ifosfamide and pegfilgrastim in treating soft tissue sarcoma
PURPOSE This randomized phase III trial is studying giving doxorubicin alone to see how well it works compared to giving doxorubicin together with ifosfamide and pegfilgrastim in treating patients with locally advanced or metastatic soft tissue sarcoma
PURPOSE This randomized phase III trial is studying giving doxorubicin alone to see how well it works compared to giving doxorubicin together with ifosfamide and pegfilgrastim in treating patients with locally advanced or metastatic soft tissue sarcoma
Detailed Description:
OBJECTIVES
Compare the progression-free and overall survival of patients with locally advanced or metastatic soft tissue sarcoma treated with doxorubicin with vs without ifosfamide and pegfilgrastim as first-line therapy
Compare the response in patients treated with these regimens
Compare the treatment-related mortality of patients treated with these regimens
Compare the toxicity of these regimens in these patients
OUTLINE This is a randomized open-label multicenter study Patients are stratified according to WHO performance status 0 vs 1 age group less than 50 years of age vs 50 years of age and over presence of liver metastases yes vs no histological grade 2 vs 3 and participating center Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive doxorubicin IV on day 1 or IV continuously on days 1-3
Arm II Patients receive doxorubicin IV on days 1-3 and ifosfamide IV over 4 hours on days 1-4 Patients also receive pegfilgrastim subcutaneously on day 5
In both arms treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity
Patients are followed every 8 weeks until disease progression and then every 12 weeks thereafter
PROJECTED ACCRUAL A total of 450 patients will be accrued for this study within 4 years
Compare the progression-free and overall survival of patients with locally advanced or metastatic soft tissue sarcoma treated with doxorubicin with vs without ifosfamide and pegfilgrastim as first-line therapy
Compare the response in patients treated with these regimens
Compare the treatment-related mortality of patients treated with these regimens
Compare the toxicity of these regimens in these patients
OUTLINE This is a randomized open-label multicenter study Patients are stratified according to WHO performance status 0 vs 1 age group less than 50 years of age vs 50 years of age and over presence of liver metastases yes vs no histological grade 2 vs 3 and participating center Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive doxorubicin IV on day 1 or IV continuously on days 1-3
Arm II Patients receive doxorubicin IV on days 1-3 and ifosfamide IV over 4 hours on days 1-4 Patients also receive pegfilgrastim subcutaneously on day 5
In both arms treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity
Patients are followed every 8 weeks until disease progression and then every 12 weeks thereafter
PROJECTED ACCRUAL A total of 450 patients will be accrued for this study within 4 years
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-62012 | None | None | None |