Ignite Creation Date:
2024-05-05 @ 9:57 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003573
Status:
COMPLETED
Last Update Posted:
2014-07-25
First Post:
1999-11-01
Brief Title:
Etoposide Plus Radiation Therapy Followed by Combination Chemotherapy in Treating Children With Newly Diagnosed Advanced Medulloblastoma
Sponsor:
Childrens Oncology Group
Organization:
Childrens Oncology Group
Study Overview
Official Title:
A Phase III Feasibility Study of Oral Etoposide Given Concurrently With Radiotherapy Followed With Dose Intensive Adjuvant Chemotherapy for Children With Newly Diagnosed High Stage Medulloblastoma
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 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 radiation therapy with chemotherapy may kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of etoposide plus radiation therapy followed by combination chemotherapy in treating children with newly diagnosed advanced medulloblastoma
PURPOSE Phase II trial to study the effectiveness of etoposide plus radiation therapy followed by combination chemotherapy in treating children with newly diagnosed advanced medulloblastoma
Detailed Description:
OBJECTIVES
Assess the response rate and toxicity of oral etoposide and radiotherapy in children with newly diagnosed high stage medulloblastoma
Compare the response rate and toxicity of these patients to historical control patients registered on POG 9031
Estimate the 2-year event-free survival and overall survival of these patients
Evaluate the toxicity of dose intensive chemotherapy with oral etoposide cisplatin cyclophosphamide and vincristine following craniospinal irradiation in these patients
OUTLINE Patients begin treatment within 1 month of surgery Patients receive 6 weeks of radiotherapy to the head and spine with boosts to the posterior fossa and to sites of metastasis Patients also receive 2 courses of oral etoposide once daily for 3 weeks concurrent with and immediately following radiotherapy weeks 1-3 and 5-7
Patients then receive adjuvant chemotherapy consisting of cisplatin IV once every 4 weeks for 3 courses beginning on week 11 oral etoposide daily for 21 days every 4 weeks for 3 courses weeks 11 15 and 19 cyclophosphamide IV on days 1 and 2 with filgrastim G-CSF SQ daily for at least 10 days every 4 weeks for 8 courses weeks 23-51 and vincristine IV on days 1 8 and 15 every 4 weeks for 8 courses weeks 23-51
Patients are followed every 3 months for 1 year every 4 months for 1 year every 6 months for 1 year and annually thereafter
PROJECTED ACCRUAL A total of 48 patients will be accrued for this study within about 2 years
Assess the response rate and toxicity of oral etoposide and radiotherapy in children with newly diagnosed high stage medulloblastoma
Compare the response rate and toxicity of these patients to historical control patients registered on POG 9031
Estimate the 2-year event-free survival and overall survival of these patients
Evaluate the toxicity of dose intensive chemotherapy with oral etoposide cisplatin cyclophosphamide and vincristine following craniospinal irradiation in these patients
OUTLINE Patients begin treatment within 1 month of surgery Patients receive 6 weeks of radiotherapy to the head and spine with boosts to the posterior fossa and to sites of metastasis Patients also receive 2 courses of oral etoposide once daily for 3 weeks concurrent with and immediately following radiotherapy weeks 1-3 and 5-7
Patients then receive adjuvant chemotherapy consisting of cisplatin IV once every 4 weeks for 3 courses beginning on week 11 oral etoposide daily for 21 days every 4 weeks for 3 courses weeks 11 15 and 19 cyclophosphamide IV on days 1 and 2 with filgrastim G-CSF SQ daily for at least 10 days every 4 weeks for 8 courses weeks 23-51 and vincristine IV on days 1 8 and 15 every 4 weeks for 8 courses weeks 23-51
Patients are followed every 3 months for 1 year every 4 months for 1 year every 6 months for 1 year and annually thereafter
PROJECTED ACCRUAL A total of 48 patients will be accrued for this study within about 2 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 |
|---|---|---|---|
| CDR0000066640 | OTHER | Clinical Trialsgov | None |
| POG-9631 | OTHER | None | None |