Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003916
Status:
COMPLETED
Last Update Posted:
2012-09-24
First Post:
1999-11-01
Brief Title:
Standard Radiation Therapy With or Without Stereotactic Radiation Therapy in Treating Patients With Glioma
Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Organization:
European Organisation for Research and Treatment of Cancer - EORTC
Study Overview
Official Title:
Focal Fractionated Conformal Stereotactic Boost Following Conventional Radiotherapy of High Grade Gliomas A Randomized Phase III Study
Status:
COMPLETED
Status Verified Date:
2012-09
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 and may be an effective treatment for patients with glioma Stereotactic radiation therapy may be able to deliver x-rays directly to the tumor and cause less damage to normal tissue It is not yet known if standard radiation therapy is more effective when followed by stereotactic radiation therapy
PURPOSE Randomized phase III trial to compare the effectiveness of standard radiation therapy with or without stereotactic radiation therapy in treating patients who have glioma
PURPOSE Randomized phase III trial to compare the effectiveness of standard radiation therapy with or without stereotactic radiation therapy in treating patients who have glioma
Detailed Description:
OBJECTIVES I Compare the effect of adjuvant conventional radiotherapy with or without fractionated stereotactic boost radiotherapy on survival in patients with high grade glioma II Compare the quality of life of these patients after these therapies
OUTLINE This is a randomized study Patients are stratified according to WHO disease grade III vs IV center and age under 40 vs 40 and over Patients are randomized to undergo stereotactic radiotherapy or no further treatment after conventional radiotherapy Patients undergo conventional radiotherapy once or twice a day for up to 6 weeks Patients randomized to receive additional treatment receive stereotactically guided conformal boost radiotherapy for 4 days within 4 weeks after completion of conventional radiotherapy Quality of life is assessed before radiotherapy then at follow up visits Patients are followed every 3 months for 1 year every 6 months for 1 year and then annually thereafter
PROJECTED ACCRUAL A total of 605 patients will be accrued for this study
OUTLINE This is a randomized study Patients are stratified according to WHO disease grade III vs IV center and age under 40 vs 40 and over Patients are randomized to undergo stereotactic radiotherapy or no further treatment after conventional radiotherapy Patients undergo conventional radiotherapy once or twice a day for up to 6 weeks Patients randomized to receive additional treatment receive stereotactically guided conformal boost radiotherapy for 4 days within 4 weeks after completion of conventional radiotherapy Quality of life is assessed before radiotherapy then at follow up visits Patients are followed every 3 months for 1 year every 6 months for 1 year and then annually thereafter
PROJECTED ACCRUAL A total of 605 patients will be accrued for this study
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 |
|---|---|---|---|
| MRC-BR10 | None | None | None |
| EORTC-22972 | None | None | None |
| EORTC-26991 | None | None | None |