Clinical trial NCT01535209: Stereotactic Radiotherapy of Resection Cavity For Single Brain Metastasis Versus Whole-Brain Radiotherapy After Resection
Official title: Phase 3 Study of Stereotactic Radiotherapy of the Postoperative Resection Cavity Versus Whole-Brain Irradiation After Surgical Resection of Single Brain Metastasis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Brain Metastases
Keywords: Stereotactic radiotherapy
Whole-brain radiotherapy
Resection cavity
Lead sponsor: Maria Sklodowska-Curie National Research Institute of Oncology
Sponsor class: OTHER
Collaborators: name: Lower Silesian Oncology Center
name: Copernicus Memorial Hospital
name: Prof. Franciszek Lukaszczyk Memorial Oncology Center
First posted: 2012-02-17
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility 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

Primary outcomes:
measure: Failure-free survival
timeFrame: 5 months after radiotherapy
Secondary outcomes:
measure: Overall survival
timeFrame: 2 years
measure: Quality of life assessment
timeFrame: 2 years
measure: Time to distant intracranial progression
timeFrame: 2 years
measure: Time to local progression
timeFrame: 2 years
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: M.Sklodowska-Curie Memorial Cancer Centre
Study officials:
affiliation: M.Sklodowska-Curie Memorial Cancer Centre, Warsaw, Poland
name: Lucyna Kepka, Prof.
role: PRINCIPAL_INVESTIGATOR
References: