Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003417
Status:
COMPLETED
Last Update Posted:
2015-11-17
First Post:
1999-11-01
Brief Title:
Computer Planned Radiation Therapy Plus Chemotherapy in Treating Patients With Glioblastoma Multiforme
Sponsor:
Radiation Therapy Oncology Group
Organization:
Radiation Therapy Oncology Group
Study Overview
Official Title:
Phase III Radiation Dose Escalation Study Applying Conformal Radiation Therapy in Supratentorial Glioblastoma Multiforme
Status:
COMPLETED
Status Verified Date:
2015-11
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 Computer systems that allow doctors to create a 3-dimensional picture of the tumor in order to plan treatment may result in more effective radiation therapy Drugs used in chemotherapy use 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 Phase III trial to study the effectiveness of radiation therapy that has been planned with a computer plus chemotherapy in treating patients who have glioblastoma multiforme
PURPOSE Phase III trial to study the effectiveness of radiation therapy that has been planned with a computer plus chemotherapy in treating patients who have glioblastoma multiforme
Detailed Description:
OBJECTIVES
Determine the feasibility and toxicity of escalating doses of conformal radiotherapy planned with 3-D treatment planning plus carmustine in patients with glioblastoma multiforme
Determine dosevolume and doseanatomic characteristics that influence radiotherapy-induced CNS central nervous system toxicity
Evaluate local control survival and failure patterns of these patients treated with high doses of conformal radiotherapy to gross disease
Correlate changes on cross-sectional diagnostic MRI imaging studies to clinical or biologic endpoints
OUTLINE This is a dose-escalation study Patients are stratified according to the planned target volume ie gross residual tumor plus 3 mm less than 75 cc vs at least 75 cc
Patients undergo radiotherapy over 15-30 minutes daily 5 days a week for 6-8 weeks After 46 Gy of radiotherapy have been administered patients undergo radiotherapy field reduction and are accrued into one of four dose levels Dose level 1 closed to accrual 11601 All patients receive at least 33 radiation treatments Each patient is evaluated for acute dose-limiting toxicity for 90 days from start of therapy
Patients also receive carmustine IV over 1-2 hours daily on days 1-3 for the first week of radiotherapy Treatment repeats every 8 weeks for up to 6 courses
Patients are followed every 4 months for 2 years every 6 months for 1 year and then annually thereafter
PROJECTED ACCRUAL A total of 40 patients 20 per arm will be accrued for this study within at least 5 months
Determine the feasibility and toxicity of escalating doses of conformal radiotherapy planned with 3-D treatment planning plus carmustine in patients with glioblastoma multiforme
Determine dosevolume and doseanatomic characteristics that influence radiotherapy-induced CNS central nervous system toxicity
Evaluate local control survival and failure patterns of these patients treated with high doses of conformal radiotherapy to gross disease
Correlate changes on cross-sectional diagnostic MRI imaging studies to clinical or biologic endpoints
OUTLINE This is a dose-escalation study Patients are stratified according to the planned target volume ie gross residual tumor plus 3 mm less than 75 cc vs at least 75 cc
Patients undergo radiotherapy over 15-30 minutes daily 5 days a week for 6-8 weeks After 46 Gy of radiotherapy have been administered patients undergo radiotherapy field reduction and are accrued into one of four dose levels Dose level 1 closed to accrual 11601 All patients receive at least 33 radiation treatments Each patient is evaluated for acute dose-limiting toxicity for 90 days from start of therapy
Patients also receive carmustine IV over 1-2 hours daily on days 1-3 for the first week of radiotherapy Treatment repeats every 8 weeks for up to 6 courses
Patients are followed every 4 months for 2 years every 6 months for 1 year and then annually thereafter
PROJECTED ACCRUAL A total of 40 patients 20 per arm will be accrued for this study within at least 5 months
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 |
|---|---|---|---|
| CDR0000066432 | None | None | None |