Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006461
Status:
COMPLETED
Last Update Posted:
2013-08-09
First Post:
2000-11-06
Brief Title:
Combination Chemotherapy Followed by Second-Look Surgery and Radiation Therapy in Treating Children With Nonmetastatic Medulloblastoma or Primitive Neuroectodermal Tumor
Sponsor:
Childrens Oncology Group
Organization:
Childrens Oncology Group
Study Overview
Official Title:
Systemic Chemotherapy Second Look Surgery and Conformal Radiation Therapy Limited to the Posterior Fossa and Primary Site for Children gt to 8 Months and lt3 Years With Non-metastatic Medulloblastoma A ChildrenAposs Oncology Group Phase III Study
Status:
COMPLETED
Status Verified Date:
2013-08
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:
This phase III trial is studying how well combination chemotherapy followed by second-look surgery and radiation therapy works in treating children with nonmetastatic medulloblastoma or primitive neuroectodermal tumor 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 surgery and radiation therapy may kill more tumor cells
Detailed Description:
PRIMARY OBJECTIVES
I To determine if the proposed treatment for children 80 months and 3 years of age at registration with non-metastatic M0 medulloblastoma is more effective than the combined treatments given to children of the same age and extent of disease on POG 9233 as measured by event-free survival EFS rates
SECONDARY OBJECTIVES
I To assess the feasibility and safety of the planned use of second look surgery and focal conformal radiation therapy following chemotherapy II To determine the acute and chronic toxicities associated with the above treatment regimens
III To describe the neuropsychological and neuroendocrine effects of this systemic chemotherapy surgery and local conformal radiation IV To determine the feasibility and validity of a centralized telephone interview based data collection method for neuropsychological evaluations V To determine the incidence of atypical teratoidrhabdoid tumor ATRT in children enrolled on this study
OUTLINE This is a multicenter study
Patients receive induction chemotherapy consisting of vincristine IV on days 1 8 and 15 cisplatin IV over 6 hours on day 1 cyclophosphamide IV over 30 minutes on day 2 and oral etoposide daily on days 2-22 Treatment repeats every 28 days for a total of 4 courses After completion of induction chemotherapy patients with residual disease undergo a second resection Within 4 weeks after completion of induction chemotherapy or second resection patients receive focal conformal radiotherapy daily 5 days a week for 6 weeks Four weeks after completion of radiotherapy patients receive alternating treatments of maintenance chemotherapy Patients receive vincristine IV on days 1 8 and 15 and cyclophosphamide IV over 30 minutes on day 1 of courses 1 3 5 and 7 and oral etoposide daily on days 1-21 of courses 2 4 6 and 8 Treatment continues every 28 days for 8 courses Patients are followed every 3 months for 1 year every 4 months for 1 year every 6 months for 1 year and then annually thereafter
I To determine if the proposed treatment for children 80 months and 3 years of age at registration with non-metastatic M0 medulloblastoma is more effective than the combined treatments given to children of the same age and extent of disease on POG 9233 as measured by event-free survival EFS rates
SECONDARY OBJECTIVES
I To assess the feasibility and safety of the planned use of second look surgery and focal conformal radiation therapy following chemotherapy II To determine the acute and chronic toxicities associated with the above treatment regimens
III To describe the neuropsychological and neuroendocrine effects of this systemic chemotherapy surgery and local conformal radiation IV To determine the feasibility and validity of a centralized telephone interview based data collection method for neuropsychological evaluations V To determine the incidence of atypical teratoidrhabdoid tumor ATRT in children enrolled on this study
OUTLINE This is a multicenter study
Patients receive induction chemotherapy consisting of vincristine IV on days 1 8 and 15 cisplatin IV over 6 hours on day 1 cyclophosphamide IV over 30 minutes on day 2 and oral etoposide daily on days 2-22 Treatment repeats every 28 days for a total of 4 courses After completion of induction chemotherapy patients with residual disease undergo a second resection Within 4 weeks after completion of induction chemotherapy or second resection patients receive focal conformal radiotherapy daily 5 days a week for 6 weeks Four weeks after completion of radiotherapy patients receive alternating treatments of maintenance chemotherapy Patients receive vincristine IV on days 1 8 and 15 and cyclophosphamide IV over 30 minutes on day 1 of courses 1 3 5 and 7 and oral etoposide daily on days 1-21 of courses 2 4 6 and 8 Treatment continues every 28 days for 8 courses Patients are followed every 3 months for 1 year every 4 months for 1 year every 6 months for 1 year and then annually thereafter
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 |
|---|---|---|---|
| U10CA098543 | NIH | Childrens Oncology Group | httpsreporternihgovquickSearchU10CA098543 |
| NCI-2012-02362 | REGISTRY | None | None |
| CDR0000068269 | OTHER | None | None |
| POG-P9934 | OTHER | None | None |
| COG-P9934 | OTHER | None | None |