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Frameless Stereotactic Radiosurgery for Brain Metastases


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
Brain Metastases

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Trial Information

Frameless Stereotactic Radiosurgery for Brain Metastases


Inclusion Criteria:



- Patients with brain metastases from a biopsy-proven primary extra-cranial tumor site,
excluding lymphoma, germ cell, and small cell lung carcinoma histologies.

- One to four metastases, and all lesions < 3.5 cm in maximal diameter. Extracranial
metastases is of minimal volume or stable with treatment. - Karnofsky performance
status ≥ 70

Exclusion Criteria:

- None of the lesions is abutting or within critical neurological structures:
*brainstem

- optic chiasm

- eye, and optic nerve.

- The clearance between metastatic lesions and all critical structures must be at least
2 mm.

- Patients must not have leptomeningeal disease.

- Contraindications to imaging or radiation (e.g. pregnancy, elevated serum creatinine,
allergy to contrast agents, severe claustrophobia, metal particles in the eye).

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Quantification of patient movement occurring during treatment.

Outcome Time Frame:

overall

Safety Issue:

Yes

Principal Investigator

Jon-Paul Voroney, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Tom Baker Cancer Centre

Authority:

Canada: Health Canada

Study ID:

FRAMELESS SRS

NCT ID:

NCT01476878

Start Date:

January 2010

Completion Date:

January 2012

Related Keywords:

  • Brain Metastases
  • Radiosurgery
  • Frameless radiosurgery
  • Accuracy
  • Neoplasm Metastasis
  • Neoplasms, Second Primary
  • Brain Neoplasms

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