Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002764
Status:
COMPLETED
Last Update Posted:
2012-07-11
First Post:
1999-11-01
Brief Title:
Surgery With or Without Combination Chemotherapy in Treating Patients With Lung Metastases From 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:
METASTASECTOMY AND CHEMOTHERAPY FOR LUNG METASTASES FROM SOFT TISSUE SARCOMA A RANDOMIZED PHASE III STUDY AN INTERGROUP STUDY WITH THE SCANDINAVIAN SARCOMA GROUP
Status:
COMPLETED
Status Verified Date:
2012-07
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 Combining more than one drug may kill more tumor cells It is not yet known whether surgery plus combination chemotherapy is more effective than surgery alone in treating patients with lung metastases from soft tissue sarcoma
PURPOSE Randomized phase III trial to compare the effectiveness of surgery plus combination chemotherapy with that of surgery alone in treating patients who have soft tissue sarcoma that has spread to the lung
PURPOSE Randomized phase III trial to compare the effectiveness of surgery plus combination chemotherapy with that of surgery alone in treating patients who have soft tissue sarcoma that has spread to the lung
Detailed Description:
OBJECTIVES I Compare disease control overall survival and relapse-free survival in patients with lung metastases secondary to soft tissue sarcoma treated with high-dose doxorubicin and ifosfamide with or without filgrastim G-CSF before and after metastasectomy vs metastasectomy alone II Determine the safety and morbidity of this regimen in these patients
OUTLINE This is a randomized multicenter study Patients are stratified according to location of metastases unilateral vs bilateral Patients are randomized to 1 of 2 treatment arms Arm I Patients are assigned to regimen A or B Regimen A Patients receive high-dose doxorubicin IV and ifosfamide IV continuously on day 1 and filgrastim G-CSF subcutaneously on days 3-13 Regimen B Patients receive chemotherapy as above without G-CSF Treatment on both regimens continues every 3 weeks for 3 courses Patients then undergo radical pulmonary metastasectomy via thoracotomy or sternotomy with wedge resection or lobectomy Patients with responding disease after metastasectomy receive 2 additional courses on the regimen to which they were originally assigned Arm II Patients undergo radical pulmonary metastasectomy as in arm I Patients are followed every 3 months for 2 years every 6 months for 2 years and then annually thereafter
PROJECTED ACCRUAL A total of 340 patients 170 per treatment arm will be accrued for this study within approximately 45 years
OUTLINE This is a randomized multicenter study Patients are stratified according to location of metastases unilateral vs bilateral Patients are randomized to 1 of 2 treatment arms Arm I Patients are assigned to regimen A or B Regimen A Patients receive high-dose doxorubicin IV and ifosfamide IV continuously on day 1 and filgrastim G-CSF subcutaneously on days 3-13 Regimen B Patients receive chemotherapy as above without G-CSF Treatment on both regimens continues every 3 weeks for 3 courses Patients then undergo radical pulmonary metastasectomy via thoracotomy or sternotomy with wedge resection or lobectomy Patients with responding disease after metastasectomy receive 2 additional courses on the regimen to which they were originally assigned Arm II Patients undergo radical pulmonary metastasectomy as in arm I Patients are followed every 3 months for 2 years every 6 months for 2 years and then annually thereafter
PROJECTED ACCRUAL A total of 340 patients 170 per treatment arm will be accrued for this study within approximately 45 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 |
|---|---|---|---|
| SWOG-EORTC-62933 | None | None | None |
| EORTC-62933 | None | None | None |
| E-EORTC-62933 | None | None | None |
| SSG-EORTC-62933 | None | None | None |