Assessments and follow-up
PD, Tumor
ADVERSE EVENTS, DISEASE, TUMOR
The following parameters will be gathered at each visit: ECOG PS, vital signs, thorough physical and neurological examination including the NANO Scale, laboratory tests and adverse events. At screening, we will assess also premorbid PS as well as premorbid functional status. Before randomization, patients will be re-evaluated for HCT-ASCT eligibility.Imaging evaluation by whole brain gadolinum-enhanced MRI will be conducted after cycle 2 of R-MP (arm A) / cycle 2 of MARTA (arm B) as well as after cycle 3 of R-MP (arm A) / 30 days after ASCT (arm B).In addition to these timepoints, patients with clinical signs of progression at any time during the study treatment or if study treatment is delayed for more than 2 weeks during induction treatment will receive subsequent gadolinium-enhanced brain MRI to confirm radiologic disease status.During follow-up gadolinium-enhanced brain MRI will be performed every 3 months in year 1–2, every 6 months in year 3–5 and annually thereafter. Tumor size and location(s) will be assessed only at screening and in case of progressive disease (PD)). Tumor number (singular/multiple) will only be assessed at screening.Independent pathologic and radiologic review are implemented in this trial to assure high-level methodical and quality standards.Further information on assessments during the trial and the follow-up period are given in the appendix (see supplementary material, additional file 1: trial flow chart arm A and arm B).