Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002545
Status:
COMPLETED
Last Update Posted:
2013-08-13
First Post:
1999-11-01
Brief Title:
Radiation Therapy Plus Chemotherapy in Treating Patients With Supratentorial Glioblastoma Multiforme
Sponsor:
Radiation Therapy Oncology Group
Organization:
Radiation Therapy Oncology Group
Study Overview
Official Title:
A PHASE III TRIAL COMPARING THE USE OF RADIOSURGERY FOLLOWED BY CONVENTIONAL RADIOTHERAPY WITH BCNU TO CONVENTIONAL RADIOTHERAPY WITH BCNU FOR SUPRATENTORIAL GLIOBLASTOMA MULTIFORME
Status:
COMPLETED
Status Verified Date:
2013-08
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 Chemotherapy uses different ways to stop tumor cells from dividing so they stop growing or die Combining radiation therapy with chemotherapy may kill more tumor cells
PURPOSE Randomized phase III trial to study the effectiveness of radiation therapy and carmustine in treating patients who have supratentorial glioblastoma multiforme
PURPOSE Randomized phase III trial to study the effectiveness of radiation therapy and carmustine in treating patients who have supratentorial glioblastoma multiforme
Detailed Description:
OBJECTIVES I Determine whether the use of radiosurgery stereotactic external-beam irradiation prior to conventional radiotherapy with carmustine BCNU improves overall survival compared to conventional radiotherapy plus BCNU alone in patients with supratentorial glioblastoma multiforme II Determine and compare the frequency and severity of toxicities associated with these regimens III Compare the effects of these two regimens on neurologic function and quality of life
OUTLINE Randomized study Arm I Radiotherapy plus Single-Agent Chemotherapy Tumor irradiation using megavoltage equipment at least 4 MV photons plus Carmustine BCNU NSC-409962 Arm II Radiosurgery followed by Radiotherapy plus Single-Agent Chemotherapy Stereotactic tumor irradiation followed by tumor irradiation as in Arm I plus BCNU
PROJECTED ACCRUAL 200 patients will be entered over approximately 3 years
OUTLINE Randomized study Arm I Radiotherapy plus Single-Agent Chemotherapy Tumor irradiation using megavoltage equipment at least 4 MV photons plus Carmustine BCNU NSC-409962 Arm II Radiosurgery followed by Radiotherapy plus Single-Agent Chemotherapy Stereotactic tumor irradiation followed by tumor irradiation as in Arm I plus BCNU
PROJECTED ACCRUAL 200 patients will be entered over approximately 3 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 |
|---|---|---|---|
| CDR0000063286 | None | None | None |