Stereotactic Radiation Therapy in Treating Patients With Brain Metastases

July 23, 2020 updated by: Case Comprehensive Cancer Center

A Phase II Trial of Radiosurgery Alone for Brain Metastases in Elderly Patients or Patients With Poor Performance Status

RATIONALE: Stereotactic radiation therapy may be able to deliver x-rays directly to the tumor and cause less damage to normal tissue.

PURPOSE: Phase II trial to study the effectiveness of stereotactic radiation therapy in treating patients who have brain metastases.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES: I. Determine the efficacy of stereotactic radiosurgery without whole brain radiotherapy in elderly patients or patients with poor performance status who have brain metastases. II. Determine the neurologic function in these patients after receiving this treatment regimen. III. Determine the quality of life in these patients with this treatment regimen.

OUTLINE: Patients undergo stereotactic head frame placement, followed by stereotactic radiosurgery using Gamma Knife, on day 1. Quality of life is assessed one week prior to and one week after treatment, and then at 2, 4, 6, 8, 10, and 12 months. Patients are followed at one week, at 2, 4, 6, 8, 10, and 12 months, every 4 months for one year, and then every 6 months for 3 years.

PROJECTED ACCRUAL: Approximately 52 patients will be accrued for this study within 2 years.

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44106-5065
        • Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 120 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS: Patients with 1-4 sites of brain metastases Confirmed by MRI with gadolinium texaphyrin scan within two weeks of study If solitary metastases, diameter must be 40 mm or less If multiple metastases, one site may be greater than 30 mm, while all others must be less than 30 mm No metastases in the brainstem or within 5 mm of optic nerves or chiasm Prior surgical resection of metastases allowed if radiographically visible residual disease No prior cranial radiotherapy Patients must be over 65 years of age OR Over 18 years of age with Karnofsky performance status 40-60% All primary histologies allowed except the following: Lymphomas Leukemia Multiple myeloma Small cell lung cancer Germ cell tumors Extracranial disease allowed

PATIENT CHARACTERISTICS: Age: See Disease Characteristics Performance status: See Disease Characteristics Life expectancy: Not specified Hematopoietic: Hemoglobin greater than 8 g/dL Absolute neutrophil count greater than 1,000/mm3 Platelet count greater than 50,000/mm3 Hepatic: Not specified Renal: Not specified

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Prior chemotherapy allowed Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics Prior or concurrent radiotherapy to noncranial sites allowed Surgery: See Disease Characteristics

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Study the effectiveness of stereotactic radiation therapy in treating patients who have brain metastases.
Time Frame: Quality of life is assessed one week prior to and one week after treatment, and then at 2, 4, 6, 8, 10, and 12 months. Patients are followed at one week, at 2, 4, 6, 8, 10, and 12 months, every 4 months for one year, and then every 6 months for 3 years.
Quality of life is assessed one week prior to and one week after treatment, and then at 2, 4, 6, 8, 10, and 12 months. Patients are followed at one week, at 2, 4, 6, 8, 10, and 12 months, every 4 months for one year, and then every 6 months for 3 years.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Case Comprehensive Cancer Center

Investigators

  • Study Chair: Donald C. Shina, MD, Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2000

Primary Completion (Actual)

November 1, 2001

Study Completion (Actual)

February 1, 2005

Study Registration Dates

First Submitted

September 11, 2000

First Submitted That Met QC Criteria

March 5, 2004

First Posted (Estimate)

March 8, 2004

Study Record Updates

Last Update Posted (Actual)

July 27, 2020

Last Update Submitted That Met QC Criteria

July 23, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CWRU3399

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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