Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003052
Status:
COMPLETED
Last Update Posted:
2013-09-17
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy With or Without Hyperthermia Therapy in Treating Patients With Soft Tissue Sarcoma
Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Randomized Study Comparing Neoadjuvant Chemotherapy Etoposide Ifosfamide Adriamycin EIA Combined With Regional Hyperthermia RHT Versus Neoadjuvant Chemotherapy Alone in the Treatment of High-Risk Soft Tissue Sarcomas in Adults
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 Hyperthermia therapy kills tumor cells by heating them to several degrees above body temperature It is not known whether receiving chemotherapy plus hyperthermia is more effective than receiving chemotherapy alone in treating patients with soft tissue sarcoma
PURPOSE This randomized phase III trial is studying combination chemotherapy alone to see how well it works compared to combination chemotherapy and hyperthermia therapy in treating patients with soft tissue sarcoma
PURPOSE This randomized phase III trial is studying combination chemotherapy alone to see how well it works compared to combination chemotherapy and hyperthermia therapy in treating patients with soft tissue sarcoma
Detailed Description:
OBJECTIVES
Determine local progression-free survival of patients with high-risk soft tissue sarcoma treated with neoadjuvant etoposide ifosfamide and doxorubicin with or without regional hyperthermia
Determine the tumor response rate local disease control rate and overall survival in patients treated with this regimen
OUTLINE This is a randomized study Patients are stratified according to high-risk category S1 vs S2 vs S3 and disease site extremity vs nonextremity Patients are randomized to one of two treatment arms
Arm I Patients receive etoposide IV over 30 minutes on days 1 and 4 ifosfamide IV over 60 minutes on days 1-4 and doxorubicin IV over 30 minutes on day 1 Treatment continues every 21 days for a total of 4 courses Patients also undergo regional hyperthermia
Arm II Patients receive chemotherapy alone as in arm I Patients in both arms undergo definitive surgery 4-6 weeks after chemotherapy Patients also undergo radiotherapy beginning 4-6 weeks after surgery After completion of surgery and radiotherapy patients with non-resectable tumors showing no disease progression receive an additional 4 courses of chemotherapy with or without regional hyperthermia according to above treatment schedule
Patients are followed every 3 months for 1 year every 4 months for 2 years and then every 6 months thereafter
PROJECTED ACCRUAL A total of 340 patients 170 patients per arm will be accrued for this study within 35 years
Determine local progression-free survival of patients with high-risk soft tissue sarcoma treated with neoadjuvant etoposide ifosfamide and doxorubicin with or without regional hyperthermia
Determine the tumor response rate local disease control rate and overall survival in patients treated with this regimen
OUTLINE This is a randomized study Patients are stratified according to high-risk category S1 vs S2 vs S3 and disease site extremity vs nonextremity Patients are randomized to one of two treatment arms
Arm I Patients receive etoposide IV over 30 minutes on days 1 and 4 ifosfamide IV over 60 minutes on days 1-4 and doxorubicin IV over 30 minutes on day 1 Treatment continues every 21 days for a total of 4 courses Patients also undergo regional hyperthermia
Arm II Patients receive chemotherapy alone as in arm I Patients in both arms undergo definitive surgery 4-6 weeks after chemotherapy Patients also undergo radiotherapy beginning 4-6 weeks after surgery After completion of surgery and radiotherapy patients with non-resectable tumors showing no disease progression receive an additional 4 courses of chemotherapy with or without regional hyperthermia according to above treatment schedule
Patients are followed every 3 months for 1 year every 4 months for 2 years and then every 6 months thereafter
PROJECTED ACCRUAL A total of 340 patients 170 patients per arm will be accrued for this study within 35 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 |
|---|---|---|---|
| EORTC-62961 | None | None | None |