Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004224
Status:
COMPLETED
Last Update Posted:
2013-08-26
First Post:
2000-01-28
Brief Title:
Combination Chemotherapy Followed by Radiation Therapy in Treating Children With Localized Ependymoma
Sponsor:
Societe Internationale dOncologie Pediatrique
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
SIOP Study of Combined Modality Treatment in Childhood Ependymoma
Status:
COMPLETED
Status Verified Date:
2008-04
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 Combining more than one drug and combining chemotherapy with radiation therapy may kill more tumor cells
PURPOSE This phase II trial is studying combination chemotherapy and radiation therapy to see how well they work in treating children with localized ependymoma
PURPOSE This phase II trial is studying combination chemotherapy and radiation therapy to see how well they work in treating children with localized ependymoma
Detailed Description:
OBJECTIVES
Determine the event free and overall survival of children with incompletely resected localized ependymoma when treated with adjuvant cyclophosphamide etoposide and vincristine followed by radiotherapy
Determine the response rate in these patients to this regimen
OUTLINE This is a multicenter study
Patients undergo surgery to remove as much of tumor as possible Patients with residual disease proceed to chemotherapy while those with no residual disease proceed directly to radiotherapy
Chemotherapy begins within 3 weeks of surgery and consists of vincristine IV on days 1 8 and 15 cyclophosphamide IV over 3 hours on day 1 and etoposide IV over 4 hours on days 1-3 Treatment repeats every 4 weeks for up to 4 courses Patients who progress after 2 courses proceed to radiotherapy If residual disease is still present at completion of chemotherapy second look surgery is recommended
Patients undergo radiotherapy daily for 6 weeks beginning after complete resection within 4 weeks of surgery within 3 weeks of completion of chemotherapy or within 4 weeks of second look surgery
Patients are followed at 6 weeks after radiotherapy every 2 months for 1 year every 4 months for 2 years every 6 months for 2 years and then annually for 5 years
PROJECTED ACCRUAL A total of 65 patients will be accrued for this study within 2-3 years
Determine the event free and overall survival of children with incompletely resected localized ependymoma when treated with adjuvant cyclophosphamide etoposide and vincristine followed by radiotherapy
Determine the response rate in these patients to this regimen
OUTLINE This is a multicenter study
Patients undergo surgery to remove as much of tumor as possible Patients with residual disease proceed to chemotherapy while those with no residual disease proceed directly to radiotherapy
Chemotherapy begins within 3 weeks of surgery and consists of vincristine IV on days 1 8 and 15 cyclophosphamide IV over 3 hours on day 1 and etoposide IV over 4 hours on days 1-3 Treatment repeats every 4 weeks for up to 4 courses Patients who progress after 2 courses proceed to radiotherapy If residual disease is still present at completion of chemotherapy second look surgery is recommended
Patients undergo radiotherapy daily for 6 weeks beginning after complete resection within 4 weeks of surgery within 3 weeks of completion of chemotherapy or within 4 weeks of second look surgery
Patients are followed at 6 weeks after radiotherapy every 2 months for 1 year every 4 months for 2 years every 6 months for 2 years and then annually for 5 years
PROJECTED ACCRUAL A total of 65 patients will be accrued for this study within 2-3 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 |
|---|---|---|---|
| EU-99001 | None | None | None |
| SIOP-EPENDYMOMA-99 | None | None | None |
| AIEOP-EPENDYMOMA-99 | None | None | None |
| CCLG-EPENDYMOMA-99 | None | None | None |