Stereotactic Radiosurgery in Treating Patients With Brain Tumors
Phase I Pilot Study of Stereotaxic Radiosurgery in Patients With Intracranial Neoplasms
Sponsor: National Institutes of Health Clinical Center (CC)
This PHASE1 trial investigates Adult Brain Stem Glioma and Adult Central Nervous System Germ Cell Tumor and is currently completed. National Institutes of Health Clinical Center (CC) leads this study, which shows 6 recorded versions since 1998 — indicating limited longitudinal coverage. As an oncology study, it adds to the longitudinal record of treatment development for this indication.
Study Description(click to expand)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.
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.
Status Flow
Change History
6 versions recorded-
Sep 2024 — Present [monthly]
Completed PHASE1
-
Jul 2024 — Sep 2024 [monthly]
Completed PHASE1
-
Nov 2023 — Jul 2024 [monthly]
Completed PHASE1
-
Jan 2021 — Nov 2023 [monthly]
Completed PHASE1
-
Jun 2018 — Jan 2021 [monthly]
Completed PHASE1
▶ Show 1 earlier version
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Jan 2017 — Jun 2018 [monthly]
Completed PHASE1
First recorded
Nov 1998
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- National Institutes of Health Clinical Center (CC)
For direct contact, visit the study record on ClinicalTrials.gov .