Study on Radiosurgery Before Surgery for Treatable Brain Tumors: Phase I/II

Sponsor: Case Comprehensive Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT01891318

Provider View

This clinical trial is testing whether using radiosurgery before surgery can help prevent brain tumors from returning. It also looks at the side effects and aims to find the best dose of radiosurgery for patients with treatable brain metastases.

Patient Parameters

Program Overview

The purpose of this study is to see if using radiosurgery before surgery can effectively stop brain tumors from coming back. Radiosurgery is a precise treatment that targets the tumor with x-rays, causing less harm to healthy brain tissue. The study will also check for any side effects from this combined treatment and help find the best radiosurgery dose.

Description

The study is divided into two phases. In Phase I, researchers will focus on the safety of using radiosurgery before surgery, looking at any immediate or long-term side effects. In Phase II, they will evaluate how well this approach controls brain tumors.

Secondary goals include:

  • Checking if tumors appear in other parts of the brain after treatment.
  • Estimating how often additional treatments like surgery or whole brain radiation are needed.
  • Monitoring for any radiation-related side effects, such as tissue damage or the need for steroids.
  • Understanding the biological effects of radiosurgery on the treated brain tumors.

The study initially planned to assess changes in cognitive function and quality of life, but these outcomes were removed in an amendment.

Eligibility Criteria

Inclusion Criteria

  • Have a previous diagnosis of cancer, excluding small cell lung cancer, lymphoma, and germ cell tumors.
  • Have 1 to 4 brain tumors visible on an MRI, with at least one tumor between 20 mm and 50 mm in size, suitable for radiosurgery and complete surgical removal.
  • May have had previous radiosurgery on other brain tumors.
  • Must have a Karnofsky performance score of 70 or higher, indicating the ability to care for oneself with some assistance.

Exclusion Criteria

  • Not medically fit for brain tumor surgery.
  • Have had whole brain radiation therapy before.
  • Cannot undergo MRI scans.
  • Physical or mental limitations that prevent participation in study activities.
  • Unable or unwilling to attend all follow-up visits.
  • Cannot safely deliver the required radiation dose to the optic nerve or chiasm.
  • Tumor located in the brainstem.
  • Evidence of cancer spread to the brain's lining.

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.