A Pilot/Phase II Study of Gamma Knife Radiosurgery for Brain Metastases Using 3Tesla MRI and Rational Dose Selection

June 27, 2019 updated by: Yale University
The purpose of this study is to collect prospective data for use as a comparator for future subsequent studies attempting to increase the efficacy or reduce the toxicity of gamma knife radiosurgery.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

The aims of this study are to pilot a study to measure local control after "rational dose" selected gamma knife radiosurgery for brain metastases and to measure treatment related toxicity for rational dose selected gamma knife radiosurgery for brain metastases. In addition, the quality of life and neurocognition of patients undergoing gamma knife radiosurgery will be measured using the validated European Organisation for Research and Treatment of Cancer QLQ-C30 and QLQ-BN20 survey instruments. "Rational dose selection" is a concept wherein doses used for stereotactic radiosurgery is selected based on tumor volume, prior irradiation with whole brain radiotherapy, and the relative radioresistance of the tumor (radioresistant = melanoma, renal cell carcinoma, sarcoma; radiosensitive = breast cancer, lung cancer, colorectal cancer, gastrointestinal cancers).

Eligible patients will have histologically confirmed cancer and MRI evidence of metastatic disease within the brain. Patients will be eligible for the trial if intracranial radiosurgery has been recommended for treatment of brain metastases. Patients will be excluded if they have an extremely radiosensitive tumor (leukemia, lymphoma), a radiosensitivity syndrome, a resection of a brain metastasis, or cannot tolerate the MRI or placement of a stereotactic head frame. All patients must sign informed consent.

Radiation will consist of gamma knife radiosurgery delivered using doses selected based on the concept of "rational dose selection" as summarized above.

Study Type

Interventional

Enrollment (Actual)

39

Phase

  • Not Applicable

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
    • Connecticut
      • New Haven, Connecticut, United States, 06520
        • Yale University

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 and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients must have histologically or cytologically confirmed malignancy (not leukemia or lymphoma). There must be metastatic brain disease apparent on magnetic resonance imaging which offers a medical indication for brain radiation. - Age > 18
  • Karnofsky Performance Status > 70
  • MRI performed within 4 weeks of trial enrollment
  • Medical oncologist or consenting physician verifies that chemotherapy options exist after treatment with intracranial therapy, and that chemotherapy is planned to initiate after completion of radiation. Or, survival as estimated by the medical oncologist or enrolling physician is > 3 months.

Exclusion Criteria:

  • Extremely radiosensitive tumor (lymphoma, leukemia)
  • Radiosensitivity syndrome (scleroderma, dermatomyositis, other genetic syndrome that predisposes to adverse radiotherapy complications)
  • Evidence of leptomeningeal dissemination
  • Resection of brain metastases, otherwise untreated with radiation for those brain lesions (presenting for postoperative consolidative radiotherapy)
  • Presence of a medical device (pacemaker, stent) or allergy that precludes contrast enhanced MRI
  • Patient is unable to tolerate placement of a stereotactic headframe
  • Pregnancy

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: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Gamma Knife Radiosurgery

"Rational dose selection" is a concept wherein doses used for stereotactic radiosurgery is selected based on tumor volume, prior irradiation with whole brain radiotherapy, and the relative radioresistance of the tumor (radioresistant = melanoma, renal cell carcinoma, sarcoma; radiosensitive = breast cancer, lung cancer, colorectal cancer, gastrointestinal cancers).

Dose may be altered for lesions in the brainstem, adjacent to the optic nerve, optic chiasm, or motor cortex, or other clinical scenarios as defined by the treating physician. Reason for dose alteration will be recorded at the time of treatment.

For patients with 10+ brain metastases with multimorbidity or difficulty in tolerating a supine position, doses may be modified by the treating physicians for patient comfort.
Procedure: Gamma Knife Radiosurgery

Treatment will be administered on an outpatient basis. No other treatment, investigational or commercial agents or therapies other than those described below may be administered with the intent to treat the patient's brain metastases.

Gamma knife radiosurgery is a one day out-patient procedure. Time from initiation of treatment (premedication and placement of a stereotactic frame) until end of treatment (completion of radiation delivery and removal of stereotactic frame) ranges from 3 to 16 hours.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of Local Control Over time (RECIST Criteria)
Time Frame: Up to 2 years

Response or progression of the radiated lesion will be measured by change in the largest unidimensional measurement.

Additionally, response and progression will be evaluated in this study using the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee

Changes in only the largest diameter (unidimensional measurement) of the tumor lesions are used in the RECIST criteria. Local control is defined as a lack of progressive disease, as defined by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria of a 20% increase in the longest diameter for a target lesion.

If the lesion grows beyond 20% of the longest diameter of the pre-treatment, but subsequently regresses without further lesion-targeted radiotherapy, it will be assumed that the lesion was treatment related radiation necrosis in analysis
Up to 2 years

Collaborators and Investigators

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

Sponsor

Yale University

Investigators

  • Principal Investigator: James B Yu, MD, Yale University

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

November 1, 2013

Primary Completion (ACTUAL)

February 1, 2018

Study Completion (ACTUAL)

August 1, 2018

Study Registration Dates

First Submitted

December 3, 2013

First Submitted That Met QC Criteria

December 3, 2013

First Posted (ESTIMATE)

December 9, 2013

Study Record Updates

Last Update Posted (ACTUAL)

July 1, 2019

Last Update Submitted That Met QC Criteria

June 27, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1306012291

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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