Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003859
Status:
COMPLETED
Last Update Posted:
2013-12-04
First Post:
1999-11-01
Brief Title:
Surgery Plus Radiation Therapy With or Without Chemotherapy in Treating Children With Primitive Neuroectodermal Tumors of the CNS
Sponsor:
Societe Internationale dOncologie Pediatrique
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Trial of Chemotherapy Utilizing Carboplatin Vincristine Cyclophosphamide and Etoposide for the Treatment of Central Nervous System Primitive Neurectodermal Tumors of Childhood
Status:
COMPLETED
Status Verified Date:
2009-04
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:
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 It is not yet known whether undergoing surgery plus radiation therapy is more effective with or without chemotherapy for primitive neuroectodermal tumors of the CNS
PURPOSE Randomized phase III trial to compare the effectiveness of surgery plus radiation therapy with or without chemotherapy in treating patients who have primitive neuroectodermal tumors of the CNS
PURPOSE Randomized phase III trial to compare the effectiveness of surgery plus radiation therapy with or without chemotherapy in treating patients who have primitive neuroectodermal tumors of the CNS
Detailed Description:
OBJECTIVES I Determine whether chemotherapy utilizing carboplatin vincristine cyclophosphamide and etoposide improves the prognosis for children with primitive neuroectodermal tumors of the central nervous system when given after surgery and before radiotherapy II Assess prospective factors that may determine ultimate prognosis in this patient population III Determine the quality of survival of these patients on both treatment regimens
OUTLINE This is a randomized study Patients undergo surgical removal of the primary tumor Following surgery patients are randomized to receive radiotherapy alone arm I or chemotherapy followed by radiotherapy arm II Arm I Patients begin receiving radiotherapy as soon as possible after surgery within 28 days Radiotherapy is administered 5 times a week for 6 weeks Arm II Within 28 days of surgery patients receive vincristine IV on days 1 7 14 21 28 35 42 49 56 and 63 Carboplatin IV is administered over 1 hour on days 1 2 42 and 43 Etoposide IV is administered over 1 hour on days 1-3 21-23 42-44 and 63-65 Cyclophosphamide IV is administered over 4 hours on days 21 and 63 As soon as possible after chemotherapy patients receive radiotherapy as in arm I Quality of life is assessed every 3 months for the first year and annually thereafter Patients are followed every 6 weeks for the first year every 3 months for the second year every 4 months for the third year and every 6 months thereafter
PROJECTED ACCRUAL A total of 230 patients 115 per treatment arm will be accrued for this study
OUTLINE This is a randomized study Patients undergo surgical removal of the primary tumor Following surgery patients are randomized to receive radiotherapy alone arm I or chemotherapy followed by radiotherapy arm II Arm I Patients begin receiving radiotherapy as soon as possible after surgery within 28 days Radiotherapy is administered 5 times a week for 6 weeks Arm II Within 28 days of surgery patients receive vincristine IV on days 1 7 14 21 28 35 42 49 56 and 63 Carboplatin IV is administered over 1 hour on days 1 2 42 and 43 Etoposide IV is administered over 1 hour on days 1-3 21-23 42-44 and 63-65 Cyclophosphamide IV is administered over 4 hours on days 21 and 63 As soon as possible after chemotherapy patients receive radiotherapy as in arm I Quality of life is assessed every 3 months for the first year and annually thereafter Patients are followed every 6 weeks for the first year every 3 months for the second year every 4 months for the third year and every 6 months thereafter
PROJECTED ACCRUAL A total of 230 patients 115 per treatment arm 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 |
|---|---|---|---|
| UKCCSG-9102 | None | None | None |
| SIOP-PNET-III | None | None | None |
| EU-99003 | None | None | None |