Ignite Creation Date:
2024-05-05 @ 5:30 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00470223
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-04-18
First Post:
2007-05-03
Brief Title:
Combined Chemotherapy With or Without Zoledronic Acid for Patients With Osteosarcoma
Sponsor:
UNICANCER
Organization:
UNICANCER
Study Overview
Official Title:
OS2006 Protocole de Traitement Des ostéosarcomes de lEnfant de lAdolescent et de lAdulte Comportant
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-04
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:
OS2006
Brief Summary:
RATIONALE Drugs used in chemotherapy work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Giving more than one drug combination chemotherapy may kill more tumor cells Zoledronic acid may stop the growth of tumor cells in bone Giving chemotherapy with or without zoledronic acid before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed Giving these treatments after surgery may kill any tumor cells that remain after surgery It is not yet known whether giving combination chemotherapy together with zoledronic acid is more effective than combination chemotherapy alone in treating osteosarcoma
PURPOSE This randomized phase III trial is studying combination chemotherapy and zoledronic acid to see how well they work compared with combination chemotherapy alone in treating patients with osteosarcoma
PURPOSE This randomized phase III trial is studying combination chemotherapy and zoledronic acid to see how well they work compared with combination chemotherapy alone in treating patients with osteosarcoma
Detailed Description:
OBJECTIVES
Primary
Compare the progression-free survival of patients with osteosarcoma treated with combination chemotherapy with or without zoledronic acid
Secondary
Compare the overall survival of patients treated with these regimens
Compare the percentage of patients with a good histologic response
Compare the long and short term toxicity of these regimens in these patients
Compare the quality of life of patients treated with these regimens
OUTLINE This is a randomized multicenter study Patients are stratified according to age 18 years vs 18-25 years vs 25 years risk group nonmetastatic or resectable vs metastatic or unresectable and treatment center Patients receive either methotrexate-based chemotherapy or doxorubicin hydrochloride-based chemotherapy according to age
Methotrexate-based chemotherapy patients 25 years of age Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive methotrexate IV in weeks 1-3 7 8 12 and 13 and etoposide IV and ifosfamide IV in weeks 4 and 9
Arm II Patients receive methotrexate etoposide and ifosfamide as in arm I Patients also receive zoledronic acid IV in weeks 1 5 9 and 13
All patients undergo surgery in week 14 After surgery patients are assigned to 1 of 2 groups for further treatment based on histological response
Good responders 10 viable cells Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive methotrexate IV in weeks 1-3 7-9 13-15 and 19-21 and etoposide IV in weeks 4 and 10 Patients also receive ifosfamide IV in weeks 4 10 and 16
Arm II Patients receive methotrexate etoposide and ifosfamide as in arm I Patients also receive zoledronic acid IV in weeks 3 7 11 15 19 and 23
Bad responders 10 viable cells Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive methotrexate IV in weeks 1 5 9 13 and 17 and doxorubicin hydrochloride IV and cisplatin IV in weeks 2 6 10 14 and 18
Arm II Patients receive methotrexate doxorubicin hydrochloride and cisplatin as in arm I Patients also receive zoledronic acid IV as in arm II good responders
Doxorubicin hydrochloride-based chemotherapy patients 18 years of age Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive doxorubicin hydrochloride IV and ifosfamide hydrochloride IV in weeks 1 4 7 10 and 13 and cisplatin IV in weeks 1 7 and 13
Arm II Patients receive doxorubicin hydrochloride ifosfamide and cisplatin as in arm I Patients also receive zoledronic acid IV in weeks 1 5 9 and 13
All patients undergo surgery in week 16 After surgery patients are assigned to 1 of 2 groups for further treatment based on histological response
Good responders 10 viable cells Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive doxorubicin hydrochloride IV in weeks 1 and 7 and ifosfamide IV in weeks 1 4 7 and 10
Arm II Patients receive doxorubicin hydrochloride and ifosfamide as in arm I Patients also receive zoledronic acid IV in weeks 1 5 9 13 17 and 21
Bad responders 10 viable cells
Arm I Patients receive etoposide IV and ifosfamide IV in weeks 1 4 7 10 and 13
Arm II Patients receive etoposide and ifosfamide as in arm I Patients also receive zoledronic acid as in arm II good responders
PROJECTED ACCRUAL A total of 440 patients will be accrued for this study
Primary
Compare the progression-free survival of patients with osteosarcoma treated with combination chemotherapy with or without zoledronic acid
Secondary
Compare the overall survival of patients treated with these regimens
Compare the percentage of patients with a good histologic response
Compare the long and short term toxicity of these regimens in these patients
Compare the quality of life of patients treated with these regimens
OUTLINE This is a randomized multicenter study Patients are stratified according to age 18 years vs 18-25 years vs 25 years risk group nonmetastatic or resectable vs metastatic or unresectable and treatment center Patients receive either methotrexate-based chemotherapy or doxorubicin hydrochloride-based chemotherapy according to age
Methotrexate-based chemotherapy patients 25 years of age Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive methotrexate IV in weeks 1-3 7 8 12 and 13 and etoposide IV and ifosfamide IV in weeks 4 and 9
Arm II Patients receive methotrexate etoposide and ifosfamide as in arm I Patients also receive zoledronic acid IV in weeks 1 5 9 and 13
All patients undergo surgery in week 14 After surgery patients are assigned to 1 of 2 groups for further treatment based on histological response
Good responders 10 viable cells Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive methotrexate IV in weeks 1-3 7-9 13-15 and 19-21 and etoposide IV in weeks 4 and 10 Patients also receive ifosfamide IV in weeks 4 10 and 16
Arm II Patients receive methotrexate etoposide and ifosfamide as in arm I Patients also receive zoledronic acid IV in weeks 3 7 11 15 19 and 23
Bad responders 10 viable cells Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive methotrexate IV in weeks 1 5 9 13 and 17 and doxorubicin hydrochloride IV and cisplatin IV in weeks 2 6 10 14 and 18
Arm II Patients receive methotrexate doxorubicin hydrochloride and cisplatin as in arm I Patients also receive zoledronic acid IV as in arm II good responders
Doxorubicin hydrochloride-based chemotherapy patients 18 years of age Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive doxorubicin hydrochloride IV and ifosfamide hydrochloride IV in weeks 1 4 7 10 and 13 and cisplatin IV in weeks 1 7 and 13
Arm II Patients receive doxorubicin hydrochloride ifosfamide and cisplatin as in arm I Patients also receive zoledronic acid IV in weeks 1 5 9 and 13
All patients undergo surgery in week 16 After surgery patients are assigned to 1 of 2 groups for further treatment based on histological response
Good responders 10 viable cells Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive doxorubicin hydrochloride IV in weeks 1 and 7 and ifosfamide IV in weeks 1 4 7 and 10
Arm II Patients receive doxorubicin hydrochloride and ifosfamide as in arm I Patients also receive zoledronic acid IV in weeks 1 5 9 13 17 and 21
Bad responders 10 viable cells
Arm I Patients receive etoposide IV and ifosfamide IV in weeks 1 4 7 10 and 13
Arm II Patients receive etoposide and ifosfamide as in arm I Patients also receive zoledronic acid as in arm II good responders
PROJECTED ACCRUAL A total of 440 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 |
|---|---|---|---|
| UNICANCER-SARCOME-09-0603 | OTHER | None | None |
| 2006-003377-27 | EUDRACT_NUMBER | UNICANCER | None |