🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in China / NCT02685605
Active, not recruiting Phase 3

Intraoperative Radiotherapy in Newly Diagnosed Glioblastoma Multiforme

NCT02685605 · tracked via the Priya Life Science China tracker
Sponsor
Universitätsmedizin Mannheim
Phase
Phase 3
Started
2016-12-09
Last updated
2025-10-14

Condition(s) studied

Glioblastoma

Investigational drug(s) / intervention(s)

Standard surgeryIntraoperative radiotherapyRadiochemotherapyTemozolomide

Intraoperative radiotherapy: 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.

Radiochemotherapy: EBRT to 60 Gy plus 75 mg/m2/d temozolomide

Temozolomide: Adjuvant chemotherapy with 150-200 mg/m2/d temozolomide per cycle (5/28 days).

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (19)

FacilityCityRegionStatus
Barrow Neurological Institute (SJHMC) Phoenix Arizona
Stritch School of Medicine Loyola University Maywood Illinois
Long Island Jewish Medical Center, North Shore University Hospital Lake Success New York
Lenox Hill Hospital, Hofstra Northwell School of Medicine New York New York
West Virginia University Morgantown West Virginia
Hospital Alemão Oswaldo Cruz São Paulo Brazil
Montreal Neurological Institute and Hospital Montreal Quebec
Beijing Tian Tan Hospital, Capital Medical University Beijing China
University Hospital Augsburg Augsburg Germany
Charité - Universitätsmedizin Berlin Germany
St. Georg Hospital Leipzig Germany
University Hospital Mannheim Mannheim Germany
Technical University of Munich (TUM), Department of Radiation Oncology Munich Germany
Klinikum Stuttgart Stuttgart Germany
Helios University Hospital Wuppertal Wuppertal Germany
Gangnam Severance Hospital, Yonsei University College of Medicine Seoul South Korea
Catalan Institute of Oncology (ICO) Barcelona Spain
Hospital Reina Sofia Córdoba Spain
The London Clinic London United Kingdom

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT02685605 on ClinicalTrials.gov ↗ ← All trials in China