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Determination of the Optimal Planning Target Volume for Brain Metastases Treated With Stereotactic Radiosurgery

18 Years
80 Years
Not Enrolling
Brain Neoplasms, Brain Cancer

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Trial Information

Determination of the Optimal Planning Target Volume for Brain Metastases Treated With Stereotactic Radiosurgery

Stereotactic radiosurgery (SRS) is used either as definitive treatment alone or as a "boost"
in combination with whole-brain radiotherapy (WBRT) for the treatment of brain metastases.
To establish a target for SRS, the gross tumor volume (GTV) is typically defined as the
contrast-enhancing volume on T1-weighted axial MRI images. In turn, the volume chosen for
treatment (the planning target volume or PTV) is generated by expanding the GTV to account
for microscopic extension of tumor beyond the MRI-visualized volume and deviations in
patient positioning at the time of treatment., However, the optimal PTV in patients
undergoing SRS of brain metastases has not been established.

This pilot randomized study of 40 patients (representing a total of 80 brain metastases)
should be sufficient to explore the effect of margin expansion about the GTV for brain
metastases. The patients enrolled in this study will undergo radiosurgery to a planning
treatment volume generated by expanding the gross tumor volume by either 1- or 3-mm. Each
lesion will be randomized to receive either Arm 1 or Arm 2.

Arm 1: Planning target volume obtained by expanding the GTV 1mm ("1mm margin") Arm 2:
Planning target volume obtained by expanding the GTV 3mm ("3mm margin")

Inclusion Criteria:

- Life expectancy of at least 6 months.

- Karnofsky Performance Score greater than 70

- Graded prognostic assessment (GPA score 0.5 or greater

- 1 to 3 brain metastases unresectable

- Maximum tumor diameter no larger than 4cm

Exclusion Criteria:

- 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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

12-month local control rate

Outcome Time Frame:

1 yr

Safety Issue:


Principal Investigator

John Kirkpatrick, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Duke University Medical Center, Radiation Oncology


United States: Institutional Review Board

Study ID:




Start Date:

December 2009

Completion Date:

December 2012

Related Keywords:

  • Brain Neoplasms
  • Brain Cancer
  • Brain Metastases
  • Brain Neoplasms
  • Neoplasms



Duke University Medical CenterDurham, North Carolina  27710