Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006460
Status:
UNKNOWN
Last Update Posted:
2013-12-04
First Post:
2000-11-06
Brief Title:
Radiation Therapy Plus Hyperbaric Oxygen in Treating Patients With Newly Diagnosed Glioblastoma Multiforme
Sponsor:
Barrett Cancer Center
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase III Trial of Conformal Radiotherapy and Hyperbaric Oxygen for Patients With Newly Diagnosed Glioblastoma
Status:
UNKNOWN
Status Verified Date:
2002-05
Last Known Status:
ACTIVE_NOT_RECRUITING
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 Hyperbaric oxygen may increase the effectiveness of radiation therapy Combining hyperbaric oxygen with radiation therapy may be an effective treatment for glioblastoma multiforme
PURPOSE Phase III trial to study the effectiveness of combining radiation therapy with hyperbaric oxygen in treating patients who have newly diagnosed glioblastoma multiforme
PURPOSE Phase III trial to study the effectiveness of combining radiation therapy with hyperbaric oxygen in treating patients who have newly diagnosed glioblastoma multiforme
Detailed Description:
OBJECTIVES I Determine the feasibility and toxicity of hyperbaric oxygen combined with conformal radiotherapy in patients with newly diagnosed glioblastoma multiforme II Determine the efficacy of this regimen in terms of radiographic tumor response time to tumor progression and survival in these patients
OUTLINE Within 2 weeks after surgery patients receive hyperbaric oxygen over 90 minutes once daily followed by conformal radiotherapy twice daily 5 days a week for 17 days in the absence of unacceptable toxicity Patients are followed within 2 weeks and then every 2 months thereafter
PROJECTED ACCRUAL A total of 5-10 patients will be accrued for this study within 1 year
OUTLINE Within 2 weeks after surgery patients receive hyperbaric oxygen over 90 minutes once daily followed by conformal radiotherapy twice daily 5 days a week for 17 days in the absence of unacceptable toxicity Patients are followed within 2 weeks and then every 2 months thereafter
PROJECTED ACCRUAL A total of 5-10 patients will be accrued for this study within 1 year
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 |
|---|---|---|---|
| NCI-V00-1626 | None | None | None |
| UCMC-00021401 | None | None | None |