Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00027846
Status:
COMPLETED
Last Update Posted:
2019-08-07
First Post:
2001-12-07
Brief Title:
Observation or Radiation Therapy andor Chemotherapy and Second Surgery in Treating Children Who Have Undergone Surgery for Ependymoma
Sponsor:
Childrens Oncology Group
Organization:
Childrens Oncology Group
Study Overview
Official Title:
A Phase II Trial of Conformal Radiation Therapy for Pediatric Patients With Localized Ependymoma Chemotherapy Prior to Second Surgery for Incompletely Resected Ependymoma and Observation for Completely Resected Differentiated Supratentorial Ependymoma
Status:
COMPLETED
Status Verified Date:
2017-01
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 Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Giving chemotherapy before surgery may shrink the tumor so that it can be removed during surgery
PURPOSE Phase II trial to determine the effectiveness of specialized radiation therapy either alone or after chemotherapy and second surgery in treating children who have undergone surgery for localized ependymoma
PURPOSE Phase II trial to determine the effectiveness of specialized radiation therapy either alone or after chemotherapy and second surgery in treating children who have undergone surgery for localized ependymoma
Detailed Description:
OBJECTIVES
Determine the local control and pattern of failure in children with completely resected differentiated supratentorial localized ependymoma after initial surgical resection alone
Determine the rate of complete resection with second surgery after chemotherapy in patients with initially incompletely resected localized ependymoma
Determine the local control and pattern of failure in patients treated with conformal radiotherapy
Determine the influence of histologic grade on the time to progression in patients after treatment with conformal radiotherapy
OUTLINE This is a multicenter study Patients are stratified according to extent of prior surgical resection
Group 1 patients with supratentorial differentiated ependymoma who have undergone gross total resection and have no visible residual tumor Patients undergo observation
Group 2 patients with supratentorial anaplastic ependymoma or infratentorial anaplastic or differentiated ependymoma who have undergone gross total resection or near total resection Patients undergo conformal radiotherapy to the brain once daily 5 days a week for 6-6½ weeks
Group 3 patients with tumor of any histology or location who have undergone subtotal resection Patients receive an initial course of chemotherapy comprising vincristine IV on days 1 and 8 carboplatin IV over 1 hour on day 1 and cyclophosphamide IV over 1 hour on days 1 and 2 Patients also receive filgrastim G-CSF subcutaneously or IV beginning on day 3 and continuing until blood counts recover Patients then receive a second course of chemotherapy comprising vincristine IV on days 1 and 8 carboplatin IV over 1 hour on day 1 and oral etoposide on days 1-21 After completion of chemotherapy patients are evaluated for second surgery Patients who have unresectable disease undergo conformal radiotherapy Patients who have resectable disease undergo second surgery followed by conformal radiotherapy
Patients are followed every 4 months for 3 years every 6 months for 2 years and then annually thereafter
PROJECTED ACCRUAL A total of 250-350 patients will be accrued for this study within 5 years
Determine the local control and pattern of failure in children with completely resected differentiated supratentorial localized ependymoma after initial surgical resection alone
Determine the rate of complete resection with second surgery after chemotherapy in patients with initially incompletely resected localized ependymoma
Determine the local control and pattern of failure in patients treated with conformal radiotherapy
Determine the influence of histologic grade on the time to progression in patients after treatment with conformal radiotherapy
OUTLINE This is a multicenter study Patients are stratified according to extent of prior surgical resection
Group 1 patients with supratentorial differentiated ependymoma who have undergone gross total resection and have no visible residual tumor Patients undergo observation
Group 2 patients with supratentorial anaplastic ependymoma or infratentorial anaplastic or differentiated ependymoma who have undergone gross total resection or near total resection Patients undergo conformal radiotherapy to the brain once daily 5 days a week for 6-6½ weeks
Group 3 patients with tumor of any histology or location who have undergone subtotal resection Patients receive an initial course of chemotherapy comprising vincristine IV on days 1 and 8 carboplatin IV over 1 hour on day 1 and cyclophosphamide IV over 1 hour on days 1 and 2 Patients also receive filgrastim G-CSF subcutaneously or IV beginning on day 3 and continuing until blood counts recover Patients then receive a second course of chemotherapy comprising vincristine IV on days 1 and 8 carboplatin IV over 1 hour on day 1 and oral etoposide on days 1-21 After completion of chemotherapy patients are evaluated for second surgery Patients who have unresectable disease undergo conformal radiotherapy Patients who have resectable disease undergo second surgery followed by conformal radiotherapy
Patients are followed every 4 months for 3 years every 6 months for 2 years and then annually thereafter
PROJECTED ACCRUAL A total of 250-350 patients will be accrued for this study within 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 |
|---|---|---|---|
| COG-ACNS0121 | OTHER | Childrens Oncology Group | None |
| CDR0000069086 | OTHER | None | None |
| NCI-2012-02431 | OTHER | None | None |