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Fig. 2 | Trials

Fig. 2

From: A randomized controlled phase II trial of vaccination with lysate-loaded, mature dendritic cells integrated into standard radiochemotherapy of newly diagnosed glioblastoma (GlioVax): study protocol for a randomized controlled trial

Fig. 2

Visits for enrollment, treatment and assessments. After screening for eligibility and allocation (visits − 3 to − 1), 18 study visits (visits 0–17) are planned for treatment and assessments during the treatment period, followed by 8 additional visits (visits 18–25) during the 2-year follow-up. 1Resection is performed in week 0 (visit − 2); 2weeks 5–10: 6 cycles of concomitant radiochemotherapy; 3weeks 15, 19, 23, 27, 31, 35): 6 cycles (days 1–5 of 28-day cycle) of adjuvant temozolomide (TMZ) chemotherapy; 4weeks 11–14: 4 priming vaccinations; 5weeks 17, 21, 25: 3 boost vaccinations; 6weeks 16, 28, 37: magnetic resonance imaging (MRI) scans; 7weeks 5, 10: clinical, clinical chemistry, hematological, hemostaseological examinations and adverse events (AE), concomitant medication and KPS assessments; 8weeks 11–14: clinical, clinical chemistry, hematological, hemostaseological examinations and AE and concomitant medication assessments; 9weeks 15, 17, 21, 25, 29, 33, 38: clinical, clinical chemistry, hematological, hemostaseological examinations and AE and concomitant medication assessments; 10week 10: neurological performance and quality of life assessments; 11weeks 15, 29, 38: KPS, neurological performance and quality of life assessments; 12tumor tissue and blood for translational research studies are sampled during resection, leukapheresis and at the 7 time points of vaccination; 13pregnancy tests are performed at monthly intervals until 6 months after the treatment period; *vaccination arm only

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