Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002875
Status:
COMPLETED
Last Update Posted:
2014-08-01
First Post:
1999-11-01
Brief Title:
Radiation Therapy Plus Combination Chemotherapy in Treating Children With Medulloblastoma
Sponsor:
Childrens Oncology Group
Organization:
Childrens Oncology Group
Study Overview
Official Title:
Phase III Prospective Randomized Study of Craniospinal RT Followed by One of Two Adjuvant Chemotherapy Regimens CCNU CDDP VCR OR CPM CDDP VCR for Newly-Diagnosed Average Risk MedulloblastomaMEDULLOBLASTOMA
Status:
COMPLETED
Status Verified Date:
2014-07
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 Radiation therapy uses high energy x-rays to damage tumor cells Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Combining radiation therapy with chemotherapy may kill more tumor cells It is not yet known which chemotherapy regimen is more effective when combined with radiation therapy for treating medulloblastoma
PURPOSE Randomized phase III trial to compare two combination chemotherapy treatments plus radiation therapy in treating children with newly diagnosed medulloblastoma
PURPOSE Randomized phase III trial to compare two combination chemotherapy treatments plus radiation therapy in treating children with newly diagnosed medulloblastoma
Detailed Description:
OBJECTIVES I Assess whether a cyclophosphamide-containing combination chemotherapy regimen increases progression-free survival compared to a lomustine-containing regimen in children with newly diagnosed average-risk medulloblastoma II Determine progression-free and overall survival of children treated with craniospinal radiotherapy and local boost radiotherapy for a total dose of 5580 cGy followed by adjuvant lomustinecisplatinvincristine vs cyclophosphamidecisplatinvincristine III Determine the long-term neurocognitive endocrinologic and cardiopulmonary sequelae associated with craniospinal radiotherapy local boost radiotherapy and adjuvant chemotherapy in these children and determine whether replacement of lomustine with cyclophosphamide alters the incidence and degree of sequelae IV Determine whether cellular and biologic parameters including tumor molecular genetic analysis DNA ploidy mitotic activity markers and immunohistochemical analysis are correlated with progression-free survival overall survival and patterns of disease relapse in these patients V Evaluate the utility of routine magnetic resonance imaging surveillance studies of the head and spine in detecting subclinical recurrent disease
OUTLINE This is a randomized study Patients are stratified by participating institution Following surgery patients are randomized to one of two groups The first group receives craniospinal irradiation followed by a boost to the primary tumor Beginning within 1 week after initiation of radiotherapy patients receive vincristine weekly for 8 doses Beginning 6 weeks after the completion of radiotherapy patients receive adjuvant lomustinevincristinecisplatin every 6 weeks for a total of 8 courses The second group receives craniospinal irradiation plus vincristine as above followed by adjuvant cyclophosphamidevincristinecisplatin every 6 weeks for a total of 8 courses Patients are followed every 3 months for 1 year every 6 months for 2 years then annually
PROJECTED ACCRUAL It is anticipated that 240-300 patients will be entered over 4 years
OUTLINE This is a randomized study Patients are stratified by participating institution Following surgery patients are randomized to one of two groups The first group receives craniospinal irradiation followed by a boost to the primary tumor Beginning within 1 week after initiation of radiotherapy patients receive vincristine weekly for 8 doses Beginning 6 weeks after the completion of radiotherapy patients receive adjuvant lomustinevincristinecisplatin every 6 weeks for a total of 8 courses The second group receives craniospinal irradiation plus vincristine as above followed by adjuvant cyclophosphamidevincristinecisplatin every 6 weeks for a total of 8 courses Patients are followed every 3 months for 1 year every 6 months for 2 years then annually
PROJECTED ACCRUAL It is anticipated that 240-300 patients will be entered over 4 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 |
|---|---|---|---|
| CDR0000065160 | OTHER | Clinical Trialsgov | None |
| CCG-A9961 | OTHER | None | None |
| POG-A9961 | OTHER | None | None |