Ignite Creation Date:
2024-05-05 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006734
Status:
COMPLETED
Last Update Posted:
2023-08-03
First Post:
2000-12-06
Brief Title:
Comparison of Combination Chemotherapy Regimens in Treating Patients With Ewings Sarcoma or Neuroectodermal Tumor
Sponsor:
Childrens Oncology Group
Organization:
Childrens Oncology Group
Study Overview
Official Title:
Trial of Chemotherapy Intensification Through Compression in Ewings Sarcoma and Related Tumors
Status:
COMPLETED
Status Verified Date:
2023-08
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 work in different ways to stop tumor cells from dividing so they stop growing or die Radiation therapy uses high-energy x-rays to damage tumor cells It is not yet known which chemotherapy regimen combined with radiation therapy andor surgery is more effective in treating Ewings sarcoma or primitive neuroectodermal tumor
PURPOSE Randomized phase III trial to compare the effectiveness of different chemotherapy regimens combined with radiation therapy andor surgery in treating patients who have Ewings sarcoma or primitive neuroectodermal tumor
PURPOSE Randomized phase III trial to compare the effectiveness of different chemotherapy regimens combined with radiation therapy andor surgery in treating patients who have Ewings sarcoma or primitive neuroectodermal tumor
Detailed Description:
OBJECTIVES
Compare the effect of interval-compressed vs standard chemotherapy in terms of event-free survival and overall survival in patients with newly diagnosed localized Ewings sarcoma or peripheral primitive neuroectodermal tumor
OUTLINE This is a randomized multicenter study Patients are stratified according to age under 18 years vs 18 years and over and location of primary disease pelvic vs nonpelvic Patients are randomized to 1 of 2 treatment arms for induction and continuation therapy
Induction therapy weeks 1-12
Arm I Patients receive alternating courses of chemotherapy consisting of vincristine IV on day 1 doxorubicin IV continuously over 48 hours on days 1 and 2 and cyclophosphamide IV over 1 hour on day 1 for courses 1 and 3 and ifosfamide IV over 1 hour and etoposide IV over 1-2 hours on days 1-5 for courses 2 and 4 Beginning 24 hours after the last dose of chemotherapy for each course patients receive filgrastim G-CSF subcutaneously SC daily until blood counts recover Treatment continues every 3 weeks for 4 courses
Arm II Patients receive alternating courses of chemotherapy consisting of vincristine doxorubicin and cyclophosphamide as in arm I for courses 1 3 and 5 and ifosfamide and etoposide as in arm I for courses 2 4 and 6 Patients also receive G-CSF as in arm I Treatment continues every 2 weeks for 6 courses
After completion of induction therapy patients in both arms receive local control treatment to the primary tumor Patients receive continuation chemotherapy after surgery or concurrently with radiotherapy
Continuation therapy
Arm I weeks 13-42 Patients receive additional alternating courses of chemotherapy as in arm I of induction therapy with the exception of vincristine and cyclophosphamide alone for courses 7 andor 11 andor 13 Patients also receive G-CSF as in induction therapy Treatment continues every 3 weeks for 10 courses
Arm II weeks 13-29 Patients receive additional alternating courses of chemotherapy as in arm II of induction therapy with the exception of vincristine and cyclophosphamide alone for courses 9 andor 11 andor 13 Patients also receive G-CSF as in induction therapy Treatment continues every 2 weeks for 8 courses
Patients are followed every 3 months for 4 years and then every 6 months for 1 year
PROJECTED ACCRUAL Approximately 528 patients will be accrued for this study within 4-5 years
Compare the effect of interval-compressed vs standard chemotherapy in terms of event-free survival and overall survival in patients with newly diagnosed localized Ewings sarcoma or peripheral primitive neuroectodermal tumor
OUTLINE This is a randomized multicenter study Patients are stratified according to age under 18 years vs 18 years and over and location of primary disease pelvic vs nonpelvic Patients are randomized to 1 of 2 treatment arms for induction and continuation therapy
Induction therapy weeks 1-12
Arm I Patients receive alternating courses of chemotherapy consisting of vincristine IV on day 1 doxorubicin IV continuously over 48 hours on days 1 and 2 and cyclophosphamide IV over 1 hour on day 1 for courses 1 and 3 and ifosfamide IV over 1 hour and etoposide IV over 1-2 hours on days 1-5 for courses 2 and 4 Beginning 24 hours after the last dose of chemotherapy for each course patients receive filgrastim G-CSF subcutaneously SC daily until blood counts recover Treatment continues every 3 weeks for 4 courses
Arm II Patients receive alternating courses of chemotherapy consisting of vincristine doxorubicin and cyclophosphamide as in arm I for courses 1 3 and 5 and ifosfamide and etoposide as in arm I for courses 2 4 and 6 Patients also receive G-CSF as in arm I Treatment continues every 2 weeks for 6 courses
After completion of induction therapy patients in both arms receive local control treatment to the primary tumor Patients receive continuation chemotherapy after surgery or concurrently with radiotherapy
Continuation therapy
Arm I weeks 13-42 Patients receive additional alternating courses of chemotherapy as in arm I of induction therapy with the exception of vincristine and cyclophosphamide alone for courses 7 andor 11 andor 13 Patients also receive G-CSF as in induction therapy Treatment continues every 3 weeks for 10 courses
Arm II weeks 13-29 Patients receive additional alternating courses of chemotherapy as in arm II of induction therapy with the exception of vincristine and cyclophosphamide alone for courses 9 andor 11 andor 13 Patients also receive G-CSF as in induction therapy Treatment continues every 2 weeks for 8 courses
Patients are followed every 3 months for 4 years and then every 6 months for 1 year
PROJECTED ACCRUAL Approximately 528 patients will be accrued for this study within 4-5 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 |
|---|---|---|---|
| A7983 | OTHER | Childrens Cancer Group | None |
| COG-AEWS0031 | OTHER | None | None |
| CDR0000068323 | OTHER | None | None |