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) |