Intraoperative Radiotherapy in Newly Diagnosed Glioblastoma Multiforme



Status:Recruiting
Conditions:Brain Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - 80
Updated:1/25/2019
Start Date:June 2016
End Date:February 2021
Contact:Anke Keller
Email:studien.strahlen@medma.uni-heidelberg.de
Phone:+49621383

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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
We found this trial at
6
sites
Phoenix, Arizona 85013
Principal Investigator: Peter Nakaji, MD
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Lake Success, New York 11042
Phone: +1 516-941
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Maywood, Illinois 60153
Principal Investigator: Abhishek Solanki, MD
Phone: 708-216
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Maywood, IL
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Montreal, Quebec
Principal Investigator: Kevin Petrecca, MD
Phone: +1-514-398-
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Montreal,
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Morgantown, West Virginia 26506
(304) 293-0111
Principal Investigator: Christopher P Cifarelli, MD, PhD, FAANS, FACS
Phone: 304-293-7360
West Virginia University West Virginia University, founded in 1867, has a long and rich history...
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100 East 77th Street
New York, New York 10028
Principal Investigator: John A. Boockvar, MD
Phone: 212-434-4836
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New York, NY
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