Stereotactic Radiosurgery After Surgery in Treating Patients With Brain Metastases

February 1, 2019 updated by: Duke University

Phase II Single-arm Study of Post-operative Stereotactic Radiosurgery for Brain Metastases.

RATIONALE: Stereotactic radiosurgery may be able to send x-rays directly to the tumor and cause less damage to normal tissue. Giving stereotactic radiosurgery after surgery may kill any tumor cells that remain after surgery.

PURPOSE: This phase II trial is studying how well stereotactic radiosurgery works in treating patients with brain metastases.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

Primary

  • To estimate the rate of recurrence at the surgical site in patients with brain metastases treated with adjuvant stereotactic radiosurgery (SRS) compared with historical data documenting recurrence at the surgical site after surgery and whole brain radiotherapy (WBRT).

Secondary

  • To estimate the rate of salvage WBRT, SRS, or surgery in patients treated with adjuvant SRS alone.
  • To estimate the rate of new brain metastases outside of the adjuvant SRS site.
  • To estimate patient quality of life after adjuvant SRS alone.
  • To assess the effect of surgical intervention and SRS on the preservation of neurocognitive functioning in these patients.
  • To determine the clinical significance (if any) of locally recurrent brain metastases at the time of their occurrence (mass effect, cognitive functioning, and other symptoms) in these patients.
  • To estimate the rate of death due to neurologic causes, defined as death attributable to the progression of neurological disease.
  • To estimate the overall survival of these patients.

OUTLINE: Patients undergo stereotactic radiosurgery over 30-90 minutes.

Quality of life and neurocognitive function are assessed periodically.

After completion of study therapy, patients are followed every 3 months for 1 year and then every 6 months for 1 year.

Study Type

Interventional

Enrollment (Actual)

1

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
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke 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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age >18 years of age.
  2. Gross total resection (as verified by the lack of any enhancement in the resection cavity on post-operative MRI) of single brain metastasis confirmed by histology. Patients with up to 4 metastases are eligible if the largest mass is amenable to surgical resection and all non-resected masses are amenable to SRS.
  3. Patient must be Radiation Therapy Oncology Group (RTOG) recursive partitioning analysis (RPA) Class 1 or 2.
  4. Life expectancy of at least 3 months.

Exclusion Criteria:

  1. Radiographic or cytologic evidence of leptomeningeal disease.
  2. Patient with incomplete or partial resection.
  3. Primary lesion with radiosensitive histology (i.e., small cell carcinoma, germ-cell tumors, lymphoma, leukemia, and multiple myeloma).
  4. Patients with a resection cavity > 4 cm in maximal extent in any plane on contrasted MRI scan.
  5. Lesion located in anatomic regions which are not amenable to SRS including the brain stem and optic apparatus.
  6. Pregnant or need to breast feed during the study period.
  7. Uncontrolled intercurrent illness including, but not limited to symptomatic congestive heart failure, unstable angina pectoris, or psychiatric illness.
  8. Brain surgery other than for resection of metastasis.
  9. Previous brain radiotherapy.
  10. Contraindication to SRS, WBRT, or MRI.

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)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Post-operative SRS
All patients will undergo SRS with the planned target volume (PTV) defined as the resection cavity plus a 3-mm margin after surgical resection of a single brain metastasis. Dose will be prescribed to the maximum isodose line completely encompassing the PTV using the guidelines established in RTOG 9005. All patients will be evaluated for neurocognitive function via Mini-Mental State Examination (MMSE), Quality of Life (QOL) via FACT-Br, and for local recurrence via MRI every 3 months over the course of the study.
Behavioral: MMSE
Neurocognitive function via MMSE done every 3 months for length of study.
Other Names:
  • Mini-Mental Status Exam
Behavioral: QOL via FACT-Br
Quality of Life via FACT-BR every 3 months for length of study.
Other Names:
  • Quality of Life
  • Functional Assessment of Cancer Therapy - Brain
Procedure: MRI
MRI done every 3 months for the length of the study.
Other Names:
  • Magnetic Resonance Imagine
Radiation: Post-operative SRS
Single fraction SRS is currently a viable treatment option of intracranial metastatic lesions.
Other Names:
  • SRS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrence Rate at the Surgical Site as Measured by MRI
Time Frame: 12 months
The number of months for local recurrence via MRI
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall Survival
Time Frame: 12 months
12 months
Rate of Salvage Whole-brain Radiotherapy, Stereotactic Radiosurgery (SRS), or Surgery
Time Frame: 12 months
12 months
Rate of New Brain Metastases Outside of the Adjuvant SRS Site
Time Frame: 12 months
12 months
Quality of Life as Measured by the FACT-Br Subscales
Time Frame: Every 3 months for 12 months
Every 3 months for 12 months
Preservation of Neurocognitive Function as Measured by the Mini-Mental State Exam
Time Frame: Every 3 months for 12 months.
Every 3 months for 12 months.
Clinical Significance (if Any) of Locally Recurrent Brain Metastasis at the Time of Their Occurrence (Mass Effect, Cognitive Functioning, and Other Symptoms)
Time Frame: 12 months
12 months
Rate of Death Due to Neurologic Causes
Time Frame: 12 months
12 months

Collaborators and Investigators

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

Sponsor

Duke University

Collaborators

National Cancer Institute (NCI)

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

August 1, 2008

Primary Completion (Actual)

June 1, 2009

Study Completion (Actual)

June 1, 2009

Study Registration Dates

First Submitted

December 23, 2008

First Submitted That Met QC Criteria

December 23, 2008

First Posted (Estimate)

December 24, 2008

Study Record Updates

Last Update Posted (Actual)

February 26, 2019

Last Update Submitted That Met QC Criteria

February 1, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00004373
  • DUMC-PRO00004373 (Other Identifier: DUHS IRB)
  • CDR0000630239

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.

Clinical Trials on Unspecified Adult Solid Tumor, Protocol Specific

Clinical Trials on MMSE

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Suriname

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe