Lomustine in Addition to Standard of Care in Patients With MGMT Methylated Glioblastoma

overall survival

visualized with Kaplan-Meier plot, tested with log-rank test

progression free survival (PFS)

radiological or clinical PFS according to the modified Response Assessment in Neuro-Oncology (mRANO) criteria (Kaplan-Meier plot, log-rank test)

quality of life (QoL)

According to the EORTC Quality of Life Questionnaire (EORTC QLQ-30) with brain cancer module 20; Evaluate minimal clinically important difference (MCID) (i.e. clinically relevant difference) according to guidelines. These questionnaires contain a total of 30 + 20 QoL-related questions which are scored on a nominal scale (0-5 points); the result of each question is recorded for computerized examination and the questions relating to the same dimension of QoL (e.g. emotional well-being) are taken together for an overall score of this dimension. The scores for the different dimensions will be compared between repeated assessments throughout the trial and between the two arms of the trial. Analysed at 8 different time points: 1. start of therapy = day 1 2. since first assessment 6 weeks later: middle of the first months (1.5) 3. from now on, every 6 months: month 7.5 4. month 13.5 5. month 19.5 6. month 25.5 7. month 31.5 8. month 37.5 (end of the follow-up after 4 years)

neurocognition - verbal memory

Verbal Memory Test: Participants are tasked with learning and recalling 15 words. They are asked to recognize the words among 15 distractors (other words). The test is repeated at the end of the test session (after approximately 30 minutes). This test measures how well the participant can learn and recall words. Low scores indicate verbal memory difficulties. Analysed at 8 different time points: 1. start of therapy (RT/chemotherapy/TTFields) = day 1 2. since first assessment 6 weeks later: middle of the first months (1.5) 3. from now on, every 6 months: month 7.5 4. month 13.5 5. month 19.5 6. month 25.5 7. month 31.5 8. month 37.5 (end of the follow-up after 4 years) Patients will be monitored with the "CNS Vital Signs", a validated computerized test battery with proven sensitivity to detect cognitive impairments in patients with brain tumors. The battery consists of 8 subtests.

neurocognition - visual memory

Visual Memory Test: Participants are tasked with learning and recalling 15 geometric shapes. They are asked to recognize these among 15 distractors (other shapes). The test is repeated at the end of the test session (after approximately 30 minutes). This test measures how well the participant can learn and recall geometric shapes. Low scores indicate visual memory difficulties. Analysed at 8 different time points: 1. start of therapy (RT/chemotherapy/TTFields) = day 1 2. since first assessment 6 weeks later: middle of the first months (1.5) 3. from now on, every 6 months: month 7.5 4. month 13.5 5. month 19.5 6. month 25.5 7. month 31.5 8. month 37.5 (end of the follow-up after 4 years) Patients will be monitored with the "CNS Vital Signs" (CNS = central nervous system), a validated computerized test battery with proven sensitivity to detect cognitive impairments in patients with brain tumors. The battery consists of 8 subtests.