Stereotactic Radiotherapy of Resection Cavity For Single Brain Metastasis Versus Whole-Brain Radiotherapy After Resection
Conditions
Brain Metastases
Conditions: official terms
Brain Neoplasms - Neoplasm Metastasis
Conditions: Keywords
Stereotactic radiotherapy, Whole-brain radiotherapy, Resection cavity
Study Type
Interventional
Study Phase
Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: stereotactic body radiotherapy (SBRT) Type: Radiation
Name: Whole-Brain Radiotherapy (WBRT) Type: Radiation
Overall Status
Recruiting
Summary
Adjuvant whole-brain radiation therapy (WBRT) after resection of single brain metastasis is considered as a standard associated with side effects leading to decreased neurocognitive function. The Investigators addressed the question whether stereotactic radiotherapy of the resection cavity impairs neurological status and/or cognitive functions in compare to adjuvant WBRT.
Detailed Description
Patients with surgically removed single brain metastasis are randomly allocated to control or experimental arm. Before treatment the MRC Neurological Status Scale is used for assessing neurological status, the EORTC QLQ-C30 and QLQ-BN20 for quality of life and Mini-Mental State Examination to assess cognitive functioning. The control group receive 30Gy in 10 fractions of 3Gy over 12 days to the whole brain. The patients in the experimental arm are treated with stereotactic radiotherapy to the resection cavity. The dose to the tumor bed is 15-18Gy in one fraction or 25Gy in 5 fractions. The study hypothesis is that the difference in the 5-months failure free survival rate isn't higher than 25% in experimental arm compared to control arm.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

- Patients with surgically removed histologically proven metastatic cancer

- 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:

- Dementia and central nervous system diseases leading to higher risk of radiation toxicity

- 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
Location
M.Sklodowska-Curie Memorial Cancer Centre
Warsaw, Poland
Status: Recruiting
Contact: Lucyna Kepka, Prof. - +48226439287 - lucynak@coi.waw.pl
Start Date
January 2012
Completion Date
December 2014
Sponsors
Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology
Source
Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page