Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00017147
Status:
COMPLETED
Last Update Posted:
2013-01-30
First Post:
2001-06-06
Brief Title:
S0001 RT and Carmustine With or Without O6BG in Patients With New Glioblastoma Multiforme or Gliosarcoma
Sponsor:
SWOG Cancer Research Network
Organization:
SWOG Cancer Research Network
Study Overview
Official Title:
A Phase III Study of Radiation Therapy RT and O6-Benzylguanine O6-BG Plus BCNU Versus RT and BCNU Alone for Newly Diagnosed Glioblastoma Multiforme GBM and Gliosarcoma
Status:
COMPLETED
Status Verified Date:
2013-01
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 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 O6-benzylguanine may help carmustine kill more tumor cells by making tumor cells more sensitive to the drug It is not yet known whether radiation therapy and carmustine are more effective with or without O6-benzylguanine
PURPOSE Randomized phase III trial to compare the effectiveness of radiation therapy plus carmustine with or without O6-benzylguanine in treating patients who have newly diagnosed glioblastoma multiforme or gliosarcoma
PURPOSE Randomized phase III trial to compare the effectiveness of radiation therapy plus carmustine with or without O6-benzylguanine in treating patients who have newly diagnosed glioblastoma multiforme or gliosarcoma
Detailed Description:
OBJECTIVES
Compare the overall survival failure-free survival and progression-free survival of patients with newly diagnosed glioblastoma multiforme or gliosarcoma treated with radiotherapy and carmustine with or without O6-benzylguanine
Compare the frequency and severity of toxic effects of these regimens in these patients
Correlate the survival of these patients with the expression of O6-alkylguanine-DNA alkyltransferase
OUTLINE This is a randomized study Patients are stratified according to age under 50 vs 50 and over prior surgery biopsy only vs resection and Zubrod performance status 0-1 vs 2 Patients are randomized to 1 of 2 treatment arms
Arm I Patients undergo radiotherapy daily 5 days a week over 7 weeks for a total of 34 fractions Patients also receive chemotherapy comprising O6-benzylguanine IV over 1 hour followed 6 hours later by carmustine IV over 1 hour on day 1 of radiotherapy Chemotherapy repeats every 6 weeks for a maximum of 7 courses in the absence of disease progression or unacceptable toxicity
Arm II Patients undergo radiotherapy as in arm I Patients receive carmustine IV as in arm I
Patients are followed at week 48 every 4 months for 1 year and then every 6 months for 4 years
PROJECTED ACCRUAL A total of 375 patients will be accrued for this study within 5 years
Compare the overall survival failure-free survival and progression-free survival of patients with newly diagnosed glioblastoma multiforme or gliosarcoma treated with radiotherapy and carmustine with or without O6-benzylguanine
Compare the frequency and severity of toxic effects of these regimens in these patients
Correlate the survival of these patients with the expression of O6-alkylguanine-DNA alkyltransferase
OUTLINE This is a randomized study Patients are stratified according to age under 50 vs 50 and over prior surgery biopsy only vs resection and Zubrod performance status 0-1 vs 2 Patients are randomized to 1 of 2 treatment arms
Arm I Patients undergo radiotherapy daily 5 days a week over 7 weeks for a total of 34 fractions Patients also receive chemotherapy comprising O6-benzylguanine IV over 1 hour followed 6 hours later by carmustine IV over 1 hour on day 1 of radiotherapy Chemotherapy repeats every 6 weeks for a maximum of 7 courses in the absence of disease progression or unacceptable toxicity
Arm II Patients undergo radiotherapy as in arm I Patients receive carmustine IV as in arm I
Patients are followed at week 48 every 4 months for 1 year and then every 6 months for 4 years
PROJECTED ACCRUAL A total of 375 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 |
|---|---|---|---|
| U10CA032102 | NIH | SWOG | httpsreporternihgovquickSearchU10CA032102 |
| S0001 | OTHER | None | None |