Optimal Planning Target Volume With Stereotactic Radiosurgery
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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 |
- 12-month local control rate [ Time Frame: 1 yr ] [ Designated as safety issue: No ]
- 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 2012 |
| Primary Completion Date: | December 2012 (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 |
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| United States, North Carolina | |
| Duke University Medical Center | |
| Durham, North Carolina, United States, 27710 | |
| 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: | April 15, 2013 |
| 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 June 18, 2013