Clinical trial NCT01017497: Optimal Planning Target Volume With Stereotactic Radiosurgery
Official title: Determination of the Optimal Planning Target Volume for Brain Metastases Treated With Stereotactic Radiosurgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Brain Neoplasms
Brain Cancer
Keywords: Brain Metastases
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2009-11-20
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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 approximately 49 patients (representing a total of 80 brain lesions) should be sufficient to explore the effect of margin expansion around the GTV for brain metastases. The patients enrolled in this study will undergo radiosurgery to a planning treatment volume generated by expanding the GTV of each lesion by either a 1mm or 3mm margin. Each lesion, not each patient, will be randomized to receive either the 1mm or 3mm margin with 40 lesions randomized to each arm (a patient with multiple lesions potentially could have a lesion randomized to the 1mm arm and a different lesion randomized to the 3mm arm). The primary outcome of 12-month local recurrence and the secondary outcome of the rate of radionecrosis at the SRS treatment site will be lesion-specific outcomes. All other secondary outcomes will be patient-specific outcomes.

Eligibility criteria: Inclusion Criteria:

* 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
* 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

Primary outcomes:
measure: 12-month Local Control Rate
timeFrame: 12 months after SRS
Secondary outcomes:
measure: Rate of Radionecrosis at SRS Treatment Site
timeFrame: 24 months after SRS
measure: 12 Month Rate of Distant Brain Metastases
timeFrame: 12 month after SRS
measure: Median Overall Survival
timeFrame: 24 months after SRS
measure: Quality of Life at 3 Months After SRS as Measured by the Functional Assessment of Cancer Therapy-Brain (FACT-Br)
timeFrame: Baseline to 3 months after SRS
measure: Cognition at 3 Months After SRS as Measured by the Mini-Mental State Exam (MMSE)
timeFrame: Baseline to 3 months after SRS
measure: Cognition at 3 Months After SRS as Measured by the Trail Making Test (TMT)
timeFrame: Baseline to 3 months after SRS
measure: Rate of Death Due to Neurologic Causes
timeFrame: 24 months after SRS
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University Medical Center, Radiation Oncology
name: John Kirkpatrick, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: