Table 1.
In- and exclusion criteria of the study
| Inclusion criteria | |
|---|---|
| Patients meeting all of the following criteria will be considered for admission to the trial: | |
| • |
histologically confirmed malignant melanoma (MM) |
| • |
MR-imaging confirmed >1 cerebral metastases (in case of resection, >1 remaining metastases) |
| • |
age ≥ 18 years of age |
| • |
Karnofsky Performance Score ≥60 |
| • |
For women with childbearing potential, (and men) adequate contraception. |
| • |
Ability of subject to understand character and individual consequences of the clinical trial |
| • |
Written informed consent (must be available before enrolment in the trial) |
|
Exclusion criteria | |
| Patients presenting with any of the following criteria will not be included in the trial: | |
| • |
refusal of the patients to take part in the study |
| • |
previous radiotherapy of the brain |
| • |
Patients who have not yet recovered from acute high-grade toxicities of prior therapies |
| • |
Known carcinoma < 5 years ago (excluding Carcinoma in situ of the cervix, basal cell carcinoma, squamous cell carcinoma of the skin) requiring immediate treatment interfering with study therapy |
| • |
Pregnant or lactating women |
| • |
Participation in another clinical study or observation period of competing trials, respectively |
| • | MRI contraindication (i.e. cardiac pacemaker, implanted defibrillator, certain cardiac valve replacements, certain metal implants) |