Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00020566
Status:
UNKNOWN
Last Update Posted:
2014-06-24
First Post:
2001-07-11
Brief Title:
Combination Chemotherapy With or Without Peripheral Stem Cell Transplantation Radiation Therapy andor Surgery in Treating Patients With Ewings Sarcoma
Sponsor:
University of Leicester
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
European Ewing Tumour Working Initiative of National Groups Ewing Tumour Studies 1999 EURO-EWING99
Status:
UNKNOWN
Status Verified Date:
2012-06
Last Known Status:
RECRUITING
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 Radiation therapy uses high-energy x-rays to damage tumor cells Peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy and kill more tumor cells It is not yet known if combination chemotherapy is more effective with or without radiation therapy andor surgery in treating Ewings sarcoma
PURPOSE This randomized phase III trial is studying different combination chemotherapy regimens to see how well they work when given with or without peripheral stem cell transplantation radiation therapy andor surgery in treating patients with Ewings sarcoma
PURPOSE This randomized phase III trial is studying different combination chemotherapy regimens to see how well they work when given with or without peripheral stem cell transplantation radiation therapy andor surgery in treating patients with Ewings sarcoma
Detailed Description:
OBJECTIVES
Primary
Compare the event-free and overall survival of patients with tumor of the Ewings family treated with standard induction chemotherapy comprising vincristine dactinomycin ifosfamide and etoposide VIDE followed by consolidation chemotherapy comprising vincristine dactinomycin and ifosfamide versus high-dose busulfan and melphalan Bu-Mel followed by autologous peripheral blood stem cell PBSC transplantation with or without radiotherapy andor surgery
Secondary
Determine the prognostic significance of EWS-Flil transcript in these patients
Determine the frequency and prognostic value of minimal disease in bone marrow and PBSC as determined by the presence or absence of EWS-Flil transcript in these patients
Determine the feasibility and toxicity of VIDE induction chemotherapy in these patients
Determine the response of these patients to VIDE induction chemotherapy
Determine the feasibility and toxicity of VAI consolodation chemotherapy in these patients
Determine the feasibility and toxicity of Bu-Mel consolodation chemotherapy in these patients
Determine event-free survival and overall survival of patients treated with these regimens by prognostic group analysis
OUTLINE This is a randomized multicenter study Patients are stratified according to age and local treatment of the primary tumor yes vs no
Patients receive induction chemotherapy comprising vincristine IV on day 1 and ifosfamide IV over 3 hours doxorubicin IV over 4 hours and etoposide IV over 1 hour on days 1-3 VIDE Treatment repeats every 21 days for 4 courses in the absence of unacceptable toxicity Peripheral blood stem cells PBSC are collected after course 3 andor 4 Patients are evaluated after course 4 Patients in need of early radiotherapy due to an axial tumor or patients who require radiotherapy to the brain andor spinal cord at any time during study are assigned to group 1 Patients not needing early radiotherapy are assigned to group 2
Group 1 Patients receive 2 additional courses of VIDE induction chemotherapy courses 5 and 6 Patients requiring radiotherapy to the axial tumor also undergo concurrent radiotherapy 5 days a week Some patients may then undergo surgical resection of the tumor All patients will then receive vincristine IV on day 1 and dactinomycin IV and ifosfamide IV over 3 hours on days 1 and 2 VAI Treatment repeats every 21 days for 8 courses courses 7-14 Patients requiring radiotherapy to the brain andor spinal cord also undergo concurrent radiotherapy
Group 2 Patients undergo 2 additional courses of VIDE induction chemotherapy courses 5 and 6 Some patients may then undergo surgical resection of the tumor All patients receive VAI chemotherapy as in group 1 for 1 course Patients are randomized to 1 of 2 consolidation therapy arms
Arm I Patients receive 7 additional courses of VAI chemotherapy courses 8-14 Patients with unresectable partially resected or inadequately resected disease undergo concurrent whole-lung radiotherapy for 6-12 days
Arm II Patients receive high-dose chemotherapy comprising oral busulfan every 6 hours on days -6 to -3 and melphalan IV over 30 minutes on day -2 Patients receive autologous PBSC IV on day 0 Patients with unresectable partially resected or inadequately resected disease undergo concurrent radiotherapy 5 days a week for at least 5 weeks
Patients are followed every 3 months for 4 years every 6 months for 1 year and then periodically thereafter
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL Approximately 1200 patients will be accrued for this study within approximately 7 years
Primary
Compare the event-free and overall survival of patients with tumor of the Ewings family treated with standard induction chemotherapy comprising vincristine dactinomycin ifosfamide and etoposide VIDE followed by consolidation chemotherapy comprising vincristine dactinomycin and ifosfamide versus high-dose busulfan and melphalan Bu-Mel followed by autologous peripheral blood stem cell PBSC transplantation with or without radiotherapy andor surgery
Secondary
Determine the prognostic significance of EWS-Flil transcript in these patients
Determine the frequency and prognostic value of minimal disease in bone marrow and PBSC as determined by the presence or absence of EWS-Flil transcript in these patients
Determine the feasibility and toxicity of VIDE induction chemotherapy in these patients
Determine the response of these patients to VIDE induction chemotherapy
Determine the feasibility and toxicity of VAI consolodation chemotherapy in these patients
Determine the feasibility and toxicity of Bu-Mel consolodation chemotherapy in these patients
Determine event-free survival and overall survival of patients treated with these regimens by prognostic group analysis
OUTLINE This is a randomized multicenter study Patients are stratified according to age and local treatment of the primary tumor yes vs no
Patients receive induction chemotherapy comprising vincristine IV on day 1 and ifosfamide IV over 3 hours doxorubicin IV over 4 hours and etoposide IV over 1 hour on days 1-3 VIDE Treatment repeats every 21 days for 4 courses in the absence of unacceptable toxicity Peripheral blood stem cells PBSC are collected after course 3 andor 4 Patients are evaluated after course 4 Patients in need of early radiotherapy due to an axial tumor or patients who require radiotherapy to the brain andor spinal cord at any time during study are assigned to group 1 Patients not needing early radiotherapy are assigned to group 2
Group 1 Patients receive 2 additional courses of VIDE induction chemotherapy courses 5 and 6 Patients requiring radiotherapy to the axial tumor also undergo concurrent radiotherapy 5 days a week Some patients may then undergo surgical resection of the tumor All patients will then receive vincristine IV on day 1 and dactinomycin IV and ifosfamide IV over 3 hours on days 1 and 2 VAI Treatment repeats every 21 days for 8 courses courses 7-14 Patients requiring radiotherapy to the brain andor spinal cord also undergo concurrent radiotherapy
Group 2 Patients undergo 2 additional courses of VIDE induction chemotherapy courses 5 and 6 Some patients may then undergo surgical resection of the tumor All patients receive VAI chemotherapy as in group 1 for 1 course Patients are randomized to 1 of 2 consolidation therapy arms
Arm I Patients receive 7 additional courses of VAI chemotherapy courses 8-14 Patients with unresectable partially resected or inadequately resected disease undergo concurrent whole-lung radiotherapy for 6-12 days
Arm II Patients receive high-dose chemotherapy comprising oral busulfan every 6 hours on days -6 to -3 and melphalan IV over 30 minutes on day -2 Patients receive autologous PBSC IV on day 0 Patients with unresectable partially resected or inadequately resected disease undergo concurrent radiotherapy 5 days a week for at least 5 weeks
Patients are followed every 3 months for 4 years every 6 months for 1 year and then periodically thereafter
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL Approximately 1200 patients will be accrued for this study within approximately 7 years
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EURO-EWING-INTERGROUP-EE99 | None | None | None |
| EBMT-INTERGROUP-EE99 | None | None | None |
| EORTC-62981 | None | None | None |
| GPOH-AUSTRIA-INTERGROUP-EE99 | None | None | None |
| GPOH-GERMANY-INTERGROUP-EE99 | None | None | None |
| SFOP-INTERGROUP-EE99 | None | None | None |
| SWS-SAKK-INTERGROUP-EE99 | None | None | None |
| CCLG-INTERGROUP-EE99 | None | None | None |
| COG-AEWS0331 | None | None | None |
| EU-20213 | None | None | None |