Overview
INTRAGO II resembles a multicentric, prospective, randomized, 2-arm, open-label clinical phase III trial which tests if the median progression-free survival (PFS) of patients with newly diagnosed glioblastoma multiforme (GBM) can be improved by the addition of intraoperative radiotherapy (IORT) to standard radiochemotherapy.
Eligibility
Inclusion Criteria
- 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
Inclusion Criteria Related to Surgery:
8. IORT must be technically feasible
9. Histology supports diagnosis of GBM
Exclusion Criteria
- Multicentric disease (e.g. in both hemispheres) or non-resectable satellite lesions
- Previous cranial radiation therapy
- 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
- Previous therapy with anti-angiogenic substances (such as bevacizumab)
- Technical impossibility to use MRI or known allergies against MRI and/or CT contrast agents
- Participation in other clinical trials testing cancer-derived investigational agents/procedures.
- Pregnant or breast feeding patients
- Fertile patients refusing to use safe contraceptive methods during the study
Exclusion Criteria Related to Surgery:
- Active egress of fluids from a ventricular defect
- In-field risk organs and/or IORT dose >8 Gy to any risk organ