Ignite Creation Date:
2024-05-05 @ 4:53 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00334867
Status:
WITHDRAWN
Last Update Posted:
2013-06-28
First Post:
2006-06-07
Brief Title:
Combination Chemotherapy With or Without Topotecan in Treating Patients With Newly Diagnosed Localized Ewings Sarcoma
Sponsor:
Childrens Oncology Group
Organization:
Childrens Oncology Group
Study Overview
Official Title:
A Phase III Randomized Trial of Adding Vincristine-Topotecan-Cyclophosphamide to Standard Chemotherapy in Initial Treatment of Non-Metastatic Ewing Sarcoma
Status:
WITHDRAWN
Status Verified Date:
2013-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
withdrawn
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 such as vincristine doxorubicin cyclophosphamide ifosfamide etoposide and topotecan 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 Giving chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed Giving chemotherapy after surgery may kill any tumor cells that remain after surgery It is not yet known which combination chemotherapy regimen is more effective in treating Ewings sarcoma
PURPOSE This randomized phase III trial is studying combination chemotherapy and topotecan to see how well they work compared with combination chemotherapy alone in treating patients with newly diagnosed localized Ewings sarcoma
PURPOSE This randomized phase III trial is studying combination chemotherapy and topotecan to see how well they work compared with combination chemotherapy alone in treating patients with newly diagnosed localized Ewings sarcoma
Detailed Description:
OBJECTIVES
Primary
Compare the event-free and overall survival of patients with newly diagnosed localized Ewings sarcoma treated with doxorubicin hydrochloride cyclophosphamide vincristine etoposide and ifosfamide with vs without topotecan hydrochloride
Compare the side effects of these regimens in these patients
Secondary
Evaluate initial tumor size as a prognostic factor for event-free survival of these patients
Evaluate histological response as a prognostic factor for event-free survival of these patients
Continue evaluation of biologic markers both as related to prognosis and as eventual therapeutic targets via encouraging concurrent enrollment on COG-AEWS02B1
Evaluate radiologic response by positron emission tomography as a prognostic factor for event-free survival
OUTLINE This is a randomized multicenter study Patients are stratified according to age 17 vs 18 years of age and primary tumor site pelvic vs nonpelvic including extra-osseous Ewings sarcoma Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive vincristine IV over 1 minute once a week on day 1 in weeks 1-3 7-9 and 13-15 doxorubicin hydrochloride IV over 15 minutes on days 1 and 2 in weeks 1 7 and 13 cyclophosphamide IV over 1 hour on day 1 in weeks 1 7 and 13 and ifosfamide IV over 1 hour and etoposide IV over 1 hour on days 1-5 in weeks 4 10 and 16 Patients undergo local therapy comprising surgical resection in approximately week 18 andor radiotherapy beginning in approximately week 19 Patients then receive vincristine as above in weeks 19-21 28-30 34-36 40-42 and 46-51 dexrazoxane hydrochloride IV over 15 minutes on days 1 and 2 and doxorubicin hydrochloride as above in weeks 19 and 28 cyclophosphamide as above in weeks 19 28 34 40 46 and 49 and ifosfamide and etoposide as above in weeks 22 25 31 37 and 43
Arm II Patients receive vincristine IV over 1 minute once a week on day 1 in weeks 1-3 7-9 and 13-16 topotecan hydrochloride IV over 30 minutes on days 1-5 in weeks 1 and 13 cyclophosphamide IV over 30 minutes on days 1-5 in weeks 1 and 13 and IV over 1 hour on day 1 in weeks 7 and 16 ifosfamide IV over 1 hour and etoposide IV over 1 hour on days 1-5 in weeks 4 and 10 and doxorubicin hydrochloride IV over 15 minutes on days 1 and 2 in weeks 7 and 16 Patients undergo local therapy comprising surgical resection in approximately week 18 andor radiotherapy beginning in approximately week 19 Patients then receive vincristine as above in weeks 19-21 28-33 37-42 and 46-48 topotecan hydrochloride as above in weeks 19 31 and 40 cyclophosphamide IV over 30 minutes in weeks 19 31 and 40 and IV over 1 hour in weeks 28 37 and 46 ifosfamide and etoposide as above in weeks 22 25 34 43 and 49 dexrazoxane hydrochloride IV over 15 minutes on days 1 and 2 in weeks 37 and 46 and doxorubicin hydrochloride as above in weeks 28 37 and 46
After completion of study treatment patients are followed periodically for 5 years
PROJECTED ACCRUAL A total of 528 patients will be accrued for this study
Primary
Compare the event-free and overall survival of patients with newly diagnosed localized Ewings sarcoma treated with doxorubicin hydrochloride cyclophosphamide vincristine etoposide and ifosfamide with vs without topotecan hydrochloride
Compare the side effects of these regimens in these patients
Secondary
Evaluate initial tumor size as a prognostic factor for event-free survival of these patients
Evaluate histological response as a prognostic factor for event-free survival of these patients
Continue evaluation of biologic markers both as related to prognosis and as eventual therapeutic targets via encouraging concurrent enrollment on COG-AEWS02B1
Evaluate radiologic response by positron emission tomography as a prognostic factor for event-free survival
OUTLINE This is a randomized multicenter study Patients are stratified according to age 17 vs 18 years of age and primary tumor site pelvic vs nonpelvic including extra-osseous Ewings sarcoma Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive vincristine IV over 1 minute once a week on day 1 in weeks 1-3 7-9 and 13-15 doxorubicin hydrochloride IV over 15 minutes on days 1 and 2 in weeks 1 7 and 13 cyclophosphamide IV over 1 hour on day 1 in weeks 1 7 and 13 and ifosfamide IV over 1 hour and etoposide IV over 1 hour on days 1-5 in weeks 4 10 and 16 Patients undergo local therapy comprising surgical resection in approximately week 18 andor radiotherapy beginning in approximately week 19 Patients then receive vincristine as above in weeks 19-21 28-30 34-36 40-42 and 46-51 dexrazoxane hydrochloride IV over 15 minutes on days 1 and 2 and doxorubicin hydrochloride as above in weeks 19 and 28 cyclophosphamide as above in weeks 19 28 34 40 46 and 49 and ifosfamide and etoposide as above in weeks 22 25 31 37 and 43
Arm II Patients receive vincristine IV over 1 minute once a week on day 1 in weeks 1-3 7-9 and 13-16 topotecan hydrochloride IV over 30 minutes on days 1-5 in weeks 1 and 13 cyclophosphamide IV over 30 minutes on days 1-5 in weeks 1 and 13 and IV over 1 hour on day 1 in weeks 7 and 16 ifosfamide IV over 1 hour and etoposide IV over 1 hour on days 1-5 in weeks 4 and 10 and doxorubicin hydrochloride IV over 15 minutes on days 1 and 2 in weeks 7 and 16 Patients undergo local therapy comprising surgical resection in approximately week 18 andor radiotherapy beginning in approximately week 19 Patients then receive vincristine as above in weeks 19-21 28-33 37-42 and 46-48 topotecan hydrochloride as above in weeks 19 31 and 40 cyclophosphamide IV over 30 minutes in weeks 19 31 and 40 and IV over 1 hour in weeks 28 37 and 46 ifosfamide and etoposide as above in weeks 22 25 34 43 and 49 dexrazoxane hydrochloride IV over 15 minutes on days 1 and 2 in weeks 37 and 46 and doxorubicin hydrochloride as above in weeks 28 37 and 46
After completion of study treatment patients are followed periodically for 5 years
PROJECTED ACCRUAL A total of 528 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 |
|---|---|---|---|
| CDR0000483611 | OTHER | Clinical Trialsgov | None |
| COG-AEWS0531 | OTHER | None | None |