Ignite Creation Date:
2024-05-05 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00053183
Status:
COMPLETED
Last Update Posted:
2009-02-09
First Post:
2003-01-27
Brief Title:
Surgery Followed by Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase I Brachytherapy Dose Escalation Using The GliaSite RTS In Newly Diagnosed Glioblastoma Multiforme In Conjunction With External Beam Radiation Therapy
Status:
COMPLETED
Status Verified Date:
2004-07
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 Internal radiation uses radioactive material placed directly into or near a tumor to kill tumor cells External-beam radiation therapy uses high-energy x-rays to kill tumor cells Combining internal radiation with external-beam radiation therapy may kill any remaining tumor cells following surgery
PURPOSE Phase I trial to study the effectiveness of combining internal radiation therapy with external-beam radiation therapy in treating patients who have undergone surgery for glioblastoma multiforme
PURPOSE Phase I trial to study the effectiveness of combining internal radiation therapy with external-beam radiation therapy in treating patients who have undergone surgery for glioblastoma multiforme
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose of brachytherapy administered via GliaSite RTS applicator followed by external beam radiotherapy in patients with newly diagnosed glioblastoma multiforme
Determine the acute and chronic toxicity of brachytherapy administered via GliaSite RTS in these patients
Determine the survival rate of patients treated with this regimen
OUTLINE This is a multicenter dose-escalation study of brachytherapy
Patients undergo craniotomy for histologic confirmation of glioblastoma multiforme surgical resection and placement of a GliaSite RTS applicator that includes Iotrex
Beginning 3-21 days after surgery patients undergo brachytherapy via the GliaSite RTS applicator Within 30 days of brachytherapy no more than 60 days after resection patients undergo external beam radiotherapy 5 days a week for 6 weeks in the absence of disease progression or unacceptable toxicity
Cohorts of 5-10 patients receive escalating doses of brachytherapy until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which at least 2 of 5 or 3 of 10 patients experience dose-limiting toxicity
Patients are followed at 21-35 days every 2 months for 1 year and then for survival
PROJECTED ACCRUAL A total of 15-100 patients will be accrued for this study
Determine the maximum tolerated dose of brachytherapy administered via GliaSite RTS applicator followed by external beam radiotherapy in patients with newly diagnosed glioblastoma multiforme
Determine the acute and chronic toxicity of brachytherapy administered via GliaSite RTS in these patients
Determine the survival rate of patients treated with this regimen
OUTLINE This is a multicenter dose-escalation study of brachytherapy
Patients undergo craniotomy for histologic confirmation of glioblastoma multiforme surgical resection and placement of a GliaSite RTS applicator that includes Iotrex
Beginning 3-21 days after surgery patients undergo brachytherapy via the GliaSite RTS applicator Within 30 days of brachytherapy no more than 60 days after resection patients undergo external beam radiotherapy 5 days a week for 6 weeks in the absence of disease progression or unacceptable toxicity
Cohorts of 5-10 patients receive escalating doses of brachytherapy until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which at least 2 of 5 or 3 of 10 patients experience dose-limiting toxicity
Patients are followed at 21-35 days every 2 months for 1 year and then for survival
PROJECTED ACCRUAL A total of 15-100 patients will be accrued for this study
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 |
|---|---|---|---|
| JHOC-NABTT-2105 | None | None | None |
| NABTT-2105 | None | None | None |