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Intraoperative Radiotherapy in Newly Diagnosed Glioblastoma Multiforme

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Disease Information

Descriptive Information
Brief Title † Intraoperative Radiotherapy in Newly Diagnosed Glioblastoma Multiforme
Official Title † A Multicenter Randomized Phase III Trial on INTraoperative RAdiotherapy in Newly Diagnosed GliOblastoma Multiforme (INTRAGO II)
Brief Summary 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.
Detailed Description
Study Phase Phase 3
Study Type † Interventional
Study Design †
Primary Outcome Measure † Median Progression-Free Survival
Secondary Outcome Measure † Median Overall Survival
Condition † Glioblastoma
Intervention † ProcedureStandard surgery (neuronavigation-guided)
Study Arms / Comparison Groups Experimental Arm (A) Standard surgery plus intraoperative radiotherapy (20-30 Gy) followed by radiochemotherapy (EBRT: 60 Gy, 75 mg/m2/d temozolomide) and adjuvant chemotherapy with 150-200 mg/m2/d temozolomide per cycle (5/28 days). Control Arm (B) Standard surgery followed by radiochemotherapy (EBRT: 60 Gy, 75 mg/m2/d temozolomide) and adjuvant chemotherapy with 150-200 mg/m2/d temozolomide per cycle (5/28 days).
Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status † Procedure
Estimated Enrollment † 314
Start Date † June 2016
Completion Date February 2021
Primary Completion Date June 2020
Eligibility Criteria † Inclusion Criteria: 1. Age ≥18 and ≤ 70 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 informed consent 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 ≥ 145.000/μL - WBC ≥ 4.000/μL - Hemoglobin ≥ 12.0 g/dL Liver Function: - ASAT and ALAT ≤ 1.5 times ULN - ALP ≤ 2.5 times ULN - Total Serum Bilirubin 8 Gy to any risk organ
Gender All
Ages 18 Years - N/A
Accepts Healthy Volunteers No
Contacts †† Anke Keller, +49621383, studien.strahlen@medma.uni-heidelberg.de
Location Countries † Canada
Administrative Information
NCT ID † NCT02685605
Organization ID INTRAGO-II
Secondary IDs †† ARO-2016-1
Responsible Party Principal Investigator
Study Sponsor † Universitätsmedizin Mannheim
Collaborators †† Carl Zeiss Meditec AG, Oberkochen, Germany
Investigators † Principal Investigator: Frank A. Giordano, MD, Department of Radiation Oncology, University Medical Center Mannheim, University of Heidelberg, Mannheim, Germany
Information Provided By
Verification Date June 2017
First Received Date † February 5, 2016
Last Updated Date June 4, 2017
† Required WHO trial registration data element.
†† WHO trial registration data element that is required only if it exists.
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