Ignite Creation Date:
2024-05-04 @ 6:49 PM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002641
Status:
COMPLETED
Last Update Posted:
2014-08-08
First Post:
1999-11-01
Brief Title:
Surgery With or Without Chemotherapy in Treating Patients With 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 ADJUVANT CHEMOTHERAPY WITH HIGH-DOSE DOXORUBICIN IFOSFAMIDE AND LENOGRASTIM IN HIGH GRADE SOFT TISSUE SARCOMA
Status:
COMPLETED
Status Verified Date:
2002-07
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 giving chemotherapy after surgery is more effective than surgery alone in treating soft tissue sarcoma
PURPOSE Randomized phase III trial to compare the effectiveness of surgery with or without chemotherapy in treating patients who have soft tissue sarcoma
PURPOSE Randomized phase III trial to compare the effectiveness of surgery with or without chemotherapy in treating patients who have soft tissue sarcoma
Detailed Description:
OBJECTIVES
Compare the local disease control overall survival and relapse-free survival in patients with high-grade soft tissue sarcoma treated with adjuvant high-dose doxorubicin and ifosfamide plus filgrastim G-CSF vs no adjuvant chemotherapy and G-CSF after definitive surgery
Compare the toxicity and morbidity of these regimens in these patients
OUTLINE This is a randomized multicenter study Patients are stratified according to center site of primary tumor extremity vs trunk including shoulder pelvic girdle head or neck vs central including intrathoracic visceral uterine or retroperitoneal size of primary tumor less than 5 cm vs 5 cm or greater in largest diameter postoperative radiotherapy yes vs no and isolated limb perfusion therapy yes vs no
Some patients undergo isolated limb perfusion therapy with cytotoxics andor cytokines
No more than 8 weeks after biopsy or inadequate surgery patients undergo definitive surgery Patients with complete resection undergo radiotherapy assessment and then randomization Patients with incomplete or marginal resection except for central lesions undergo re-excision and in the absence of macroscopic disease assessment for postoperative radiotherapy followed by randomization
Randomization Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive no adjuvant chemotherapy or filgrastim G-CSF Beginning within 6 weeks after surgery eligible patients undergo radiotherapy as outlined below
Arm II Beginning within 4 weeks after surgery patients receive high-dose doxorubicin IV over 20 minutes followed by ifosfamide IV over 24 hours and G-CSF subcutaneously daily beginning 24 hours after completion of ifosfamide infusion and continuing for 10 days Treatment continues every 3 weeks for 5 courses Beginning within 6 weeks after completion of chemotherapy eligible patients undergo radiotherapy as outlined below
Radiotherapy Patients with incomplete or marginal resection undergo radiotherapy 5 days a week for 6-66 weeks Patients with complete microscopic resection undergo radiotherapy 5 days a week for 5 weeks followed by boost radiotherapy 5 days a week for 1 week
Patients are followed every 2 months for 1 year every 3 months for 2 years every 6 months for 1 year and then annually thereafter
PROJECTED ACCRUAL A total of 350 patients will be accrued for this study within 35 years
Compare the local disease control overall survival and relapse-free survival in patients with high-grade soft tissue sarcoma treated with adjuvant high-dose doxorubicin and ifosfamide plus filgrastim G-CSF vs no adjuvant chemotherapy and G-CSF after definitive surgery
Compare the toxicity and morbidity of these regimens in these patients
OUTLINE This is a randomized multicenter study Patients are stratified according to center site of primary tumor extremity vs trunk including shoulder pelvic girdle head or neck vs central including intrathoracic visceral uterine or retroperitoneal size of primary tumor less than 5 cm vs 5 cm or greater in largest diameter postoperative radiotherapy yes vs no and isolated limb perfusion therapy yes vs no
Some patients undergo isolated limb perfusion therapy with cytotoxics andor cytokines
No more than 8 weeks after biopsy or inadequate surgery patients undergo definitive surgery Patients with complete resection undergo radiotherapy assessment and then randomization Patients with incomplete or marginal resection except for central lesions undergo re-excision and in the absence of macroscopic disease assessment for postoperative radiotherapy followed by randomization
Randomization Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive no adjuvant chemotherapy or filgrastim G-CSF Beginning within 6 weeks after surgery eligible patients undergo radiotherapy as outlined below
Arm II Beginning within 4 weeks after surgery patients receive high-dose doxorubicin IV over 20 minutes followed by ifosfamide IV over 24 hours and G-CSF subcutaneously daily beginning 24 hours after completion of ifosfamide infusion and continuing for 10 days Treatment continues every 3 weeks for 5 courses Beginning within 6 weeks after completion of chemotherapy eligible patients undergo radiotherapy as outlined below
Radiotherapy Patients with incomplete or marginal resection undergo radiotherapy 5 days a week for 6-66 weeks Patients with complete microscopic resection undergo radiotherapy 5 days a week for 5 weeks followed by boost radiotherapy 5 days a week for 1 week
Patients are followed every 2 months for 1 year every 3 months for 2 years every 6 months for 1 year and then annually thereafter
PROJECTED ACCRUAL A total of 350 patients will be accrued for this study within 35 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-62931 | None | None | None |
| CAN-NCIC-SR3 | None | None | None |