NCT00019578

Stereotactic Radiosurgery in Treating Patients With Brain Tumors

Phase I Pilot Study of Stereotaxic Radiosurgery in Patients With Intracranial Neoplasms

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: —
• Sponsor: National Institutes of Health Clinical Center (CC) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

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.

Conditions

• Adult Central Nervous System Germ Cell Tumor
• Adult Malignant Meningioma
• Adult Medulloblastoma
• Adult Noninfiltrating Astrocytoma
• Adult Oligodendroglioma
• Adult Craniopharyngioma
• Adult Meningioma
• Brain Metastases
• Adult Ependymoma
• Adult Pineal Parenchymal Tumor
• Adult Brain Stem Glioma
• Adult Infiltrating Astrocytoma
• Mixed Gliomas
• Stage IV Peripheral Primitive Neuroectodermal Tumor

Interventions

Type	Name	Description
PROCEDURE	Sterotactic radiosurgery

Timeline

• Start date: 1998-11-01
• Completion: 2002-05-01
• First posted: 2007-03-02
• Last updated: 2023-10-31

Locations

1 site across 1 country: United States