NCT01017497

Brief Summary

The purpose of this study is to estimate the rate of local control at the treated site of the metastasis as a function of 1mm versus 3mm expansion about the gross tumor volume (GTV). Each lesion, not each patient will be ranndomized to either the 1mm or 3mm margin with 40 lesions randomized to each arm.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
49

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 19, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 20, 2009

Completed
11 days until next milestone

Study Start

First participant enrolled

December 1, 2009

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
11 months until next milestone

Results Posted

Study results publicly available

October 27, 2014

Completed
Last Updated

February 13, 2015

Status Verified

January 1, 2015

Enrollment Period

4 years

First QC Date

November 19, 2009

Results QC Date

September 30, 2014

Last Update Submit

January 27, 2015

Conditions

Brain NeoplasmsBrain Cancer

Keywords

Brain Metastases

Outcome Measures

Primary Outcomes (1)

  • 12-month Local Control Rate

    The 12-month local control rate is the percentage of lesions without recurrence at the lesion site 12 months after SRS. Time to local recurrence was defined as the time between SRS and local recurrence. If local recurrence did not occur, the time to local recurrence was censored at last follow-up (including deaths without local recurrence). Kaplan-Meier methods were used to describe the time to local recurrence.

    12 months after SRS

Secondary Outcomes (7)

  • Rate of Radionecrosis at SRS Treatment Site

    24 months after SRS

  • 12 Month Rate of Distant Brain Metastases

    12 month after SRS

  • Median Overall Survival

    24 months after SRS

  • Quality of Life at 3 Months After SRS as Measured by the Functional Assessment of Cancer Therapy-Brain (FACT-Br)

    Baseline to 3 months after SRS

  • Cognition at 3 Months After SRS as Measured by the Mini-Mental State Exam (MMSE)

    Baseline to 3 months after SRS

  • +2 more secondary outcomes

Study Arms (2)

1mm margin

EXPERIMENTAL

GTV expanded by 1 mm

Radiation: Stereotactic Radiosurgery

3mm margin

EXPERIMENTAL

GTV expanded by 3 mm

Radiation: Stereotactic Radiosurgery

Interventions

Stereotactic RadiosurgeryRADIATION

PTV Diameter \< 2.0 cm receives 24 Gy; PTV Diameter 2.0-3.0 cm receives 18 Gy; PTV Diameter 3.1-4.0 cm receives 15 Gy;

1mm margin3mm margin

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \>18 years
  • Life expectancy of at least 6 months.
  • Karnofsky Performance Score greater than 70
  • Graded prognostic assessment (GPA score 0.5 or greater
  • to 3 brain metastases unresectable
  • Maximum tumor diameter no larger than 4cm

You may not qualify if:

  • Primary lesion with radiosensitive histology (such as: small cell carcinoma, germ-cell tumors, lymphoma, leukemia, and multiple myeloma.
  • Metastases in the brain stem, pons or medulla or within 5 mm of optic apparatus
  • Previous cranial radiation
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Brain Neoplasms

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Central Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

RadiotherapyTherapeuticsStereotaxic TechniquesNeurosurgical ProceduresSurgical Procedures, OperativeInvestigative Techniques

Results Point of Contact

Title
John Kirkpatrick MD
Organization
Duke University Medical Center
john.kirkpatrick@dm.duke.edu
919 6687342

Study Officials

  • John Kirkpatrick, MD, PhD

    Duke University Medical Center, Radiation Oncology

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 19, 2009

First Posted

November 20, 2009

Study Start

December 1, 2009

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

February 13, 2015

Results First Posted

October 27, 2014

Record last verified: 2015-01

Locations

US(1)