Stereotactic Radiotherapy of Resection Cavity For Single Brain Metastasis Versus Whole-Brain Radiotherapy After Resection
NCT ID: NCT01535209
Last Updated: 2012-02-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
100 participants
INTERVENTIONAL
2012-01-31
2014-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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SBRT to resection cavity
18Gy in 1 fraction for resection cavity \<2cm in maximum diameter, 15Gy in 1 fraction for resection cavity 2.1-3cm in maximum diameter, 15Gy in 1 fraction or 25 Gy in 5 fractions over 5 days for resection cavity 3.1-4cm in maximum diameter, 25 Gy in 5 fractions over 5 days for resection cavity \>4cm in maximum diameter
stereotactic body radiotherapy (SBRT)
18Gy in 1 fraction for resection cavity \<2cm in maximum diameter, 15Gy in 1 fraction for resection cavity 2.1-3cm in maximum diameter, 15Gy in 1 fraction or 25 Gy in 5 fractions over 5 days for resection cavity 3.1-4cm in maximum diameter, 25 Gy in 5 fractions over 5 days for resection cavity \>4cm in maximum diameter
WBRT
30Gy in 10 fractions over 12 days to whole brain
Whole-Brain Radiotherapy (WBRT)
10 x 3 Gy to whole brain
Interventions
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stereotactic body radiotherapy (SBRT)
18Gy in 1 fraction for resection cavity \<2cm in maximum diameter, 15Gy in 1 fraction for resection cavity 2.1-3cm in maximum diameter, 15Gy in 1 fraction or 25 Gy in 5 fractions over 5 days for resection cavity 3.1-4cm in maximum diameter, 25 Gy in 5 fractions over 5 days for resection cavity \>4cm in maximum diameter
Whole-Brain Radiotherapy (WBRT)
10 x 3 Gy to whole brain
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subtotal or total resection of single brain metastasis
* Presence of single brain metastasis in MRI
* Karnofsky Performance Status ≥ 70
* Life expectancy \> 6 months (minimal extracranial disease or availability of effective oncology treatment)
* No previous history of cranial irradiation
* Availability of MRI
* Starting radiotherapy within six weeks after neurosurgery
* Negative pregnancy test for woman
* Written informed consent
Exclusion Criteria
* Contraindications for MRI and/or no patient's tolerance and acceptance of cranial MRI
* Altered level of consciousness
* Histologically proven metastatic small cell lung cancer
18 Years
ALL
No
Sponsors
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Lower Silesian Oncology Center
UNKNOWN
Copernicus Memorial Hospital
OTHER
Prof. Franciszek Lukaszczyk Memorial Oncology Center
OTHER
Maria Sklodowska-Curie National Research Institute of Oncology
OTHER
Responsible Party
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Principal Investigators
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Lucyna Kepka, Prof.
Role: PRINCIPAL_INVESTIGATOR
M.Sklodowska-Curie Memorial Cancer Centre, Warsaw, Poland
Locations
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M.Sklodowska-Curie Memorial Cancer Centre
Warsaw, , Poland
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CAVITY
Identifier Type: -
Identifier Source: org_study_id
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