A Multicenter Randomized Phase III Trial on INTraoperative RAdiotherapy in Newly Diagnosed GliOblastoma Multiforme (INTRAGO II) (INTRAGO-II)

  • STATUS
    Recruiting
  • participants needed
    314
  • sponsor
    Universitätsmedizin Mannheim
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Updated on 20 July 2022
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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.

Details
Condition Glioblastoma
Age 18years - 80years
Treatment Temozolomide, Standard surgery, Intraoperative radiotherapy, Radiochemotherapy
Clinical Study IdentifierNCT02685605
SponsorUniversitätsmedizin Mannheim
Last Modified on20 July 2022

Eligibility

 Yes No Not Sure

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
\. IORT must be technically feasible
\. 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
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