Study of Fractionated Stereotactic Radiosurgery to Treat Large Brain Metastases

Not Recruiting

Trial ID: NCT00928226

Purpose

The maximum tolerated dose of 3-session (ie, treatment) stereotactic radiosurgery (SRS) to treat brain metastases greater than 4.2 cm³ in size will be determined. This study investigates if increasing radiation dose improves outcome for patients without greater toxicity (side effects).

Official Title

A Phase I/II Study of Fractionated Stereotactic Radiosurgery to Treat Large Brain Metastases

Stanford Investigator(s)

Scott G. Soltys, MD
Scott G. Soltys, MD

Professor of Radiation Oncology (Radiation Therapy) and, by courtesy, of Neurosurgery

Gordon Li, MD
Gordon Li, MD

Professor of Neurosurgery and, by courtesy, of Neurology and of Otolaryngology - Head & Neck Surgery (OHNS)

Steven D. Chang, MD
Steven D. Chang, MD

Robert C. and Jeannette Powell Neurosciences Professor and, by courtesy, of Otolaryngology - Head & Neck Surgery (OHNS) and of Neurology

Iris C. Gibbs, MD, FACR, FASTRO
Iris C. Gibbs, MD, FACR, FASTRO

Professor of Radiation Oncology (Radiation Therapy) and, by courtesy, of Neurosurgery

Eligibility

INCLUSION CRITERIA

* Age 18 years and older
* Pathologically-proven solid tumor malignancy
* 1 to 4 brain metastases, one of which is 4.2 to 33.5 cm³.
* Prior surgery or SRS is allowed as long as the target metastatic lesion in this study has not previously been treated with SRS.
* Prior cytotoxic systemic therapy must be completed ≥ 5 days prior to radiosurgery. No concurrent cytotoxic systemic therapy along with SRS. Cytotoxic systemic therapy to start ≥ 5 days after the completion of SRS.
* Life expectancy of ≥ 12 weeks.
* Ability to understand and the willingness to sign a written informed consent.

EXCLUSION CRITERIA

* Previously treated with whole brain irradiation
* Target metastatic lesion previously been treated with SRS.
* \> 4 total brain metastases at the time of initial evaluation.
* Pregnant
* Unable to give informed consent.

Intervention(s):

radiation: Fractionated Stereotactic Radiosurgery (SRS)

procedure: Surgical resection

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
ccto-office@stanford.edu
650-498-7061

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