NCT02685605
Intraoperative Radiotherapy in Newly Diagnosed Glioblastoma Multiforme
- Martina Nesper-Brock, PhD - Role: CONTACT - Phone: +49-621-383 - Email: martina.nesper-brock@umm.de
- Clinical Trial Office UMM - Role: CONTACT - Phone: +49-621-383 - Email: strahlentherapie.studien@umm.de
PHASE3
ACTIVE_NOT_RECRUITING
NCT02685605
INTERVENTIONAL
A Multicenter Randomized Phase III Trial on INTraoperative RAdiotherapy in Newly Diagnosed GliOblastoma Multiforme (INTRAGO II)
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.
Inclusion Criteria
1. Age ≥18 and ≤ 80 years
2. Karnofsky Performance Score (KPS) ≥ 60%
3. Supratentorial T1-Gd enhancing lesion(s) amenable to total resection
4. Legal capacity and ability of subject to understand character and individual consequences of the clinical trial
5. Patient's written IC obtained at least 24h prior to surgery
6. For women with childbearing potential: adequate contraception
7. 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
1. Multicentric disease (e.g. in both hemispheres) or non-resectable satellite lesions
2. Previous cranial radiation therapy
3. Cytostatic therapy / chemotherapy for cancer within the past 5 years
4. History of cancers or other comorbidities that limit life expectancy to less than five years
5. Previous therapy with anti-angiogenic substances (such as bevacizumab)
6. Technical impossibility to use MRI or known allergies against MRI and/or CT contrast agents
7. Participation in other clinical trials testing cancer-derived investigational agents/procedures.
8. Pregnant or breast feeding patients
9. Fertile patients refusing to use safe contraceptive methods during the study
Exclusion Criteria Related to Surgery:
10. Active egress of fluids from a ventricular defect
11. In-field risk organs and/or IORT dose \>8 Gy to any risk organ
Glioblastoma
- TREATMENT
-
- Type: PROCEDURE
- Name: Standard surgery
- Description:
- Arm Group Labels: Control Arm (B), Experimental Arm (A)
-
- Type: RADIATION
- Name: Intraoperative radiotherapy
- Description: Dose to applicator surface: 20-30 Gy; Carl Zeiss INTRABEAM System. IORT with a surface dose of 30 Gy is recommended.Should the proximity to any risk structure not allow to apply 30 Gy, a dose reduction by up to 10 Gy (resulting in a surface dose of 20 Gy) is allowed.
- Arm Group Labels: Experimental Arm (A)
-
- Type: RADIATION
- Name: Radiochemotherapy
- Description: EBRT to 60 Gy plus 75 mg/m2/d temozolomide
- Arm Group Labels: Control Arm (B), Experimental Arm (A)
-
- Type: DRUG
- Name: Temozolomide
- Description: Adjuvant chemotherapy with 150-200 mg/m2/d temozolomide per cycle (5/28 days).
- Arm Group Labels: Control Arm (B), Experimental Arm (A)
- Universitätsmedizin Mannheim