Prognostic Factors, Surgical Management and Survival of Glioblastoma Patients: a Multicenter Prospective Study
Conditions: Glioblastoma
Sponsor: Larissa University Hospital

TITLE:                                                                                                                                                                                                                               
Prognostic factors, surgical management and survival of glioblastoma patients: a 
multicenter prospective study 
 
 
Larissa      08/06/2025     
ID: 27446 
 
 
 
Neurosurgery Clinic                                                            
Kostas N. Fountas, M.D., PhD, Director 
Konstantinos N. Paterakis, M.D., PhD 
Anastasia Tasiou. M.D., PhD                                                                                                      Larissa      08/06/2025 
Charalambos Gatos, Μ.D.                                                                                                           ID: 27446 
Alexandros Brotis, M.D., PhD    
Christos Tzerefos, MD. 
                                                                                                                                              
 
 
CLINICAL TRIAL PROTOCOL 
 
TITLE:  
Prognostic factors, surgical management and survival of glioblastoma patients: a 
multicenter prospective study 
 
 Brief Background: Glioblastoma remains the most prevalent and aggressive primary 
tumor of the Central Nervous system (CNS) in adults, with dismal prognosis and 
median overall survival between 14 to 20 months, despite the current advances in 
diagnostics and treatment options.   
           Aim: The aim of this study is to collect data prospectively in all glioblastoma 
patients treated in centers across Europe and the United States (US). In this data there 
will be included information regarding demographics, imaging, molecular subtypes, 
preoperative clinical status, surgical strategy in these patients, and post-operative 
management, along with any complications. Eventually this data will be assessed in 
order to distinguish the best surgical approach, according to different groups of 
 
 
Νέο Κτήριο Βιόπολις, Λάρισας- 41110  
 Tel:+30 2413-502786   Fax: +30 2413501551 
e-mail: fountas@med.uth.gr       
 
 

TITLE:                                                                                                                                                                                                                               
Prognostic factors, surgical management and survival of glioblastoma patients: a 
multicenter prospective study 
 
 
Larissa      08/06/2025     
ID: 27446 
patients (e.g. age, molecular subtype, tumor locations etc). Furthermore, treatment 
effect, tumor pseudo-progression, and recurrence management will also be assessed.  
          Study Design: This project constitutes a prospective, observational, 
multicenter study. The centers included are staffed with multiple experienced 
neurooncology surgeons. Patients will undergo a thorough demographic, family and 
medical history, and clinical examination. The patients' imaging studies will also be 
assessed. After the surgical management chosen, each patient will be closely 
monitored postoperatively until discharge. Postoperative imaging, postoperative 
neurological evaluation, and any complications will be thoroughly documented. 
Pathology reports, along with information regarding molecular subtypes will be 
included. The patients will be re-evaluated at one, three, and six months 
postoperatively, and then every three months or sooner in cases of any suspicion of 
recurrence or any changes in the patient's clinical status. 
         Patients: The investigators will include patients fulfilling the following 
eligibility criteria: Inclusion criteria:  
• 
Adult patients (>18 years of age) with  
• 
Glioblastoma based on radiographic features (Magnetic Resonance Imaging),  
• 
Patients that consent to study participation. 
Exclusion criteria:  
• 
Non adult patients (<18 years of age), 
• 
Patients that do not consent for participation in this study,  
• 
Patients with other CNS tumors (primary or secondary). 
       Intervention: Patients with tumors, compatible with glioblastomas -according to 
conventional Magnetic Resonance Imaging (MRI)- will fulfil their written consent 
and will then be included in the study. Each patient will be treated with a different 
surgical management (e.g biopsy, subtotal resection, gross-total resection, 
supramaximal resection or lobectomy) according to surgeons’ and/or patients’ choice. 
Any adjunct treatment will be documented (such as chemotherapy or/and 
radiotherapy).  

TITLE:                                                                                                                                                                                                                               
Prognostic factors, surgical management and survival of glioblastoma patients: a 
multicenter prospective study 
 
 
Larissa      08/06/2025     
ID: 27446 
       Outcome: The primary endpoints of the study are: (1) The overall survival (OS) 
of the patients (2) The progression free survival (PFS) of the patients. OS and PFS 
will be calculated in months.  
       The secondary endpoints of the study are: (1) Peri- and post-operative 
complications, (2) Length of hospital stay counted in days, (3) Preoperative and 
postoperative Karnofsky Performance Scale (KPS) score (1-100), and (4) Extent of 
Resection (EoR) (counted as the % percentage of the preoperative tumor). 
       Co-registration of: (1) Risk factors affecting OS and PFS ( patient's age, cerebral 
dominance, BMI, tumor's molecular subtype),(2) Age (measured in years), (3) 
Gender (male, female, other), (4) Other demographic information (such as 
nationality, education level), (5) Anatomic location of the tumor, (6) Size of the tumor 
before intervention (measured in cm), (7) Intake of mannitol, hypertonic saline or 
steroids, (8) Dexterity, (9) Symptoms at the time of hospital admission, and (10) 
Molecular subtype of the tumor.  
       Timing: Follow up: one month, six months, and then every three months 
postoperatively. In cases of tumor recurrence or post-discharge complications  
patients will be reassessed.  Enrollment of the first patient will take place after 
approval by the IRB and Research registration. Indicative time period: 2025 – 2030.  
       Statistical analysis: Descriptive statistics will be used to summarize count and 
continuous data. In particular, count data will be presented in absolute numbers and 
percentages, while continuous data will be given in mean (and standard deviation) or 
median values (and interquartile ranges) according to the Kolmogorov test. We will 
also use the chi-square test and logistic regression (or Kruskal-Wallis test), and linear 
regression to test for between-group differences. Statistical significance will be set at 
0.05. All statistical analyses will be carried out in R statistical environment. For count 
data the results will also be provided in odds ratio along with their 95% confidence 
interval (CI).  
 
        
 

TITLE:                                                                                                                                                                                                                               
Prognostic factors, surgical management and survival of glioblastoma patients: a 
multicenter prospective study 
 
 
Larissa      08/06/2025     
ID: 27446 
 
 
 
 
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TITLE:                                                                                                                                                                                                                               
Prognostic factors, surgical management and survival of glioblastoma patients: a 
multicenter prospective study 
 
 
Larissa      08/06/2025     
ID: 27446 
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