Stereotactic Radiotherapy of Resection Cavity For Single Brain Metastasis Versus Whole-Brain Radiotherapy After Resection

Study Overview
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Brief Summary
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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
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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.

Official Title
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Phase 3 Study of Stereotactic Radiotherapy of the Postoperative Resection Cavity Versus Whole-Brain Irradiation After Surgical Resection of Single Brain Metastasis

Conditions
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Brain Metastases

Intervention / Treatment
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* Radiation: stereotactic body radiotherapy (SBRT)
* Radiation: Whole-Brain Radiotherapy (WBRT)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SBRT to resection cavity<br>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 | Radiation: stereotactic body radiotherapy (SBRT)<br>* 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<br>* Other names: stereotactic body radiotherapy;|
| Active Comparator: WBRT<br>30Gy in 10 fractions over 12 days to whole brain | Radiation: Whole-Brain Radiotherapy (WBRT)<br>* 10 x 3 Gy to whole brain<br>* Other names: adjuvant cranial irradiation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Failure-free survival | Time to decrease in MRC scale by 1 point or in MMSE by 3 points or neurologic death. | 5 months after radiotherapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  | 2 years | 
| Quality of life assessment |  | 2 years | 
| Time to distant intracranial progression |  | 2 years | 
| Time to local progression | Time to progression in the irradiated cavity | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stereotactic radiotherapy, Whole-brain radiotherapy, Resection cavity