Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00019578
Status:
COMPLETED
Last Update Posted:
2023-10-31
First Post:
2007-03-01
Brief Title:
Stereotactic Radiosurgery in Treating Patients With Brain Tumors
Sponsor:
National Institutes of Health Clinical Center CC
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Phase I Pilot Study of Stereotaxic Radiosurgery in Patients With Intracranial Neoplasms
Status:
COMPLETED
Status Verified Date:
2012-03
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 PURPOSE Phase I trial to study the effectiveness of stereotactic radiosurgery in treating patients who have brain tumors
Detailed Description:
OBJECTIVES I Establish stereotaxic radiosurgery as a treatment technique at the National Institute of Health in patients with intracranial neoplasms
II Assess the response rate local control time to progression pattern of failure and magnetic resonance spectrographic data following this therapy in these patients
PROTOCOL OUTLINE All patients undergo stereotaxic head frame placement followed by stereotaxic radiosurgery on day 1 The dosage of radiation therapy administered is dependent on the tumor diameter
Patients are followed at 2 and 6 weeks and then every 3 months for 5 years
PROJECTED ACCRUAL
Up to 30 patients will be accrued for this study within 7-10 months
II Assess the response rate local control time to progression pattern of failure and magnetic resonance spectrographic data following this therapy in these patients
PROTOCOL OUTLINE All patients undergo stereotaxic head frame placement followed by stereotaxic radiosurgery on day 1 The dosage of radiation therapy administered is dependent on the tumor diameter
Patients are followed at 2 and 6 weeks and then every 3 months for 5 years
PROJECTED ACCRUAL
Up to 30 patients will be accrued for this study within 7-10 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 |
|---|---|---|---|
| CDR0000066758 | None | None | None |
| 99-C-0011 | None | None | None |