Intraoperative Radiotherapy in Newly Diagnosed Glioblastoma Multiforme

Korábbi kezelés

• Previous cranial radiation therapy
• Previous therapy with anti-angiogenic substances (such as bevacizumab)
• Participation in other clinical trials testing cancer-derived investigational agents/procedures.

Más betegség

• Multicentric disease (e.g. in both hemispheres) or non-resectable satellite lesions
• Cytostatic therapy / chemotherapy for cancer within the past 5 years
• History of cancers or other comorbidities that limit life expectancy to less than five years
• Technical impossibility to use MRI or known allergies against MRI and/or CT contrast agents

Egyéb

• Pregnant or breast feeding patients
• Fertile patients refusing to use safe contraceptive methods during the study
• Active egress of fluids from a ventricular defect
• In-field risk organs and/or IORT dose \>8 Gy to any risk organ

• Age ≥18 and ≤ 80 years
• Karnofsky Performance Score (KPS) ≥ 60%
• Supratentorial T1-Gd enhancing lesion(s) amenable to total resection
• Legal capacity and ability of subject to understand character and individual consequences of the clinical trial
• Patient's written IC obtained at least 24h prior to surgery
• For women with childbearing potential: adequate contraception
• Patients must have adequate organ functions
  • Bone marrow function:
  • Platelets ≥ 75.000/μL
  • WBC ≥ 3.000/μL
  • Hemoglobin ≥ 10.0 g/dL
  • Liver Function:
  • ASAT and ALAT ≤ 3.0 times ULN
  • ALP ≤ 2.5 times ULN
  • Total Serum Bilirubin \< 1.5 times ULN
  • Renal Function:
  • Serum Creatinine ≤ 1.5 times ULN
• IORT must be technically feasible
• Histology supports diagnosis of GBM