Optimal Planning Target Volume With Stereotactic Radiosurgery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01017497
First received: November 19, 2009
Last updated: January 6, 2014
Last verified: January 2014
  Purpose

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)


Condition Intervention
Brain Neoplasms
Brain Cancer
Radiation: Stereotactic Radiosurgery

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Determination of the Optimal Planning Target Volume for Brain Metastases Treated With Stereotactic Radiosurgery

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • 12-month local control rate [ Time Frame: 1 yr ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Rate of radionecrosis at SRS treatment site [ Time Frame: 1 yr ] [ Designated as safety issue: Yes ]
  • Rate of distant brain metastases [ Time Frame: 1 yr ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: 1 yr ] [ Designated as safety issue: No ]

Enrollment: 49
Study Start Date: December 2009
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
GTV expanded by 1 mm
Radiation: Stereotactic Radiosurgery
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;
Experimental: Arm 2
GTV expanded by 3 mm
Radiation: Stereotactic Radiosurgery
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;

Detailed Description:

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")

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01017497

Locations
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
Investigators
Principal Investigator: John Kirkpatrick, MD, PhD Duke University Medical Center, Radiation Oncology
  More Information

No publications provided

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01017497     History of Changes
Other Study ID Numbers: Pro00017062
Study First Received: November 19, 2009
Last Updated: January 6, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Duke University:
Brain Metastases

Additional relevant MeSH terms:
Brain Neoplasms
Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on August 27, 2014