C79.3 C43
Conditions
Interventions
Group 1: helical Tomotherapy of the whole brain (10x3Gy) with integrated boost to the brain metastases (10x5Gy) and hippocampal-sparing
Group 2: conventional whole-brain radiotherapy 10x3Gy
Sponsors
Universitätsklinikum Heidelberg
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: • 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
Exclusion criteria: • 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Toxicity quantified by absolute frequencies and percentages of side effects according to CTC Criteria Version 4. Follow-up visits every ~2 months for in total 1 year | — |
Secondary
| Measure | Time frame |
|---|---|
| imaging response, local and loco-regional progression-free survival, overall survival and quality of life Imaging response will be evaluated according to the RECIST criteria and represented by percentages. Kaplan-Meier curves will be plotted and Cox-regression analyses will be conducted to investigate possible factors influencing survival. QoL will be measured with the EORTC-QoL-Q C30 and brain module BN-20, and results will be summarized by median, minimum and maximum scores, and represented by box plots. Follow-up visits (as previously mentioned in section primary endpoint) every ~2 months for 1 year | — |
Countries
Germany
Contacts
Public ContactStudiensekretariat der Strahlentherapie
Abteilung für Strahlentherapie
Outcome results
None listed