Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002539
Status:
COMPLETED
Last Update Posted:
2012-09-24
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy and Surgery With or Without G-CSF in Treating Patients With Osteosarcoma
Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Organization:
European Organisation for Research and Treatment of Cancer - EORTC
Study Overview
Official Title:
A RANDOMISED TRIAL OF CHEMOTHERAPY WITH OR WITHOUT GRANULOCYTE COLONY-STIMULATING FACTOR IN OPERABLE OSTEOSARCOMA
Status:
COMPLETED
Status Verified Date:
2012-09
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 Colony-stimulating factors such as G-CSF may increase the number of immune cells found in bone marrow or peripheral blood and may help a persons immune system recover from the side effects of chemotherapy It is not yet known whether chemotherapy and surgery plus G-CSF is more effective than chemotherapy and surgery alone in treating patients with osteosarcoma
PURPOSE Randomized phase III trial to compare the effectiveness combination chemotherapy and surgery with or without G-CSF in treating patients who have newly diagnosed osteosarcoma
PURPOSE Randomized phase III trial to compare the effectiveness combination chemotherapy and surgery with or without G-CSF in treating patients who have newly diagnosed osteosarcoma
Detailed Description:
OBJECTIVES
Determine the overall and disease-free survival of patients with newly diagnosed osteosarcoma of the extremity treated with conventional vs intensive cisplatin and doxorubicin with or without filgrastim G-CSF before and after definitive surgery
Compare the toxicity of these regimens in these patients
Compare the response in patients treated with these regimens
OUTLINE This is a randomized multicenter study Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive conventional doxorubicin DOX IV over 4 hours on days 1-3 and cisplatin CDDP IV continuously on day 1 Treatment continues every 3 weeks for 2 courses At week 6 patients undergo amputation or local resection based on pretherapy imaging and response to chemotherapy Beginning 2 weeks after surgery patients receive 4 additional courses of conventional chemotherapy
Arm II Patients receive intensive DOX and CDDP as above on day 1 plus filgrastim G-CSF subcutaneously on days 4-13 Treatment continues every 2 weeks for 3 courses At week 6 patients undergo definitive surgery as in arm I Beginning 2 weeks after surgery patients receive 3 additional courses of intensive DOX and CDDP with G-CSF
Patients who experience disease progression during preoperative chemotherapy undergo surgery earlier than scheduled and complete all scheduled chemotherapy 6 courses after surgery at the discretion of the surgeon and oncologist Within 4 weeks after limb-sparing procedure patients with inadequate margins undergo amputation followed 2 weeks later by chemotherapy
Patients are followed monthly for 6 months every 2 months for 6 months every 3 months for 1 year every 4 months for 1 year every 6 months for 2 years and then annually thereafter
PROJECTED ACCRUAL A total of 500 patients will be accrued for this study
Determine the overall and disease-free survival of patients with newly diagnosed osteosarcoma of the extremity treated with conventional vs intensive cisplatin and doxorubicin with or without filgrastim G-CSF before and after definitive surgery
Compare the toxicity of these regimens in these patients
Compare the response in patients treated with these regimens
OUTLINE This is a randomized multicenter study Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive conventional doxorubicin DOX IV over 4 hours on days 1-3 and cisplatin CDDP IV continuously on day 1 Treatment continues every 3 weeks for 2 courses At week 6 patients undergo amputation or local resection based on pretherapy imaging and response to chemotherapy Beginning 2 weeks after surgery patients receive 4 additional courses of conventional chemotherapy
Arm II Patients receive intensive DOX and CDDP as above on day 1 plus filgrastim G-CSF subcutaneously on days 4-13 Treatment continues every 2 weeks for 3 courses At week 6 patients undergo definitive surgery as in arm I Beginning 2 weeks after surgery patients receive 3 additional courses of intensive DOX and CDDP with G-CSF
Patients who experience disease progression during preoperative chemotherapy undergo surgery earlier than scheduled and complete all scheduled chemotherapy 6 courses after surgery at the discretion of the surgeon and oncologist Within 4 weeks after limb-sparing procedure patients with inadequate margins undergo amputation followed 2 weeks later by chemotherapy
Patients are followed monthly for 6 months every 2 months for 6 months every 3 months for 1 year every 4 months for 1 year every 6 months for 2 years and then annually thereafter
PROJECTED ACCRUAL A total of 500 patients 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 |
|---|---|---|---|
| EU-93024 | None | None | None |
| EOI-80931 | None | None | None |
| EORTC-80931 | None | None | None |
| MRC-BO06 | None | None | None |