Cerveau (SNC)

TITRE Essai de phase III multicentrique avec répartition aléatoire sur la radiothérapie peropératoire dans le cas du glioblastome multiforme nouvellement diagnostiqué
PROTOCOLE ID INTRAGO II
CLINICAL TRIAL.gov ID NCT02685605
TYPE(S) DE CANCER Cerveau (SNC)
PHASE Phase III
TYPE D'ÉTUDE Traitement
INSTITUTION CENTRE UNIVERSITAIRE DE SANTE MCGILL
1001 boul. Décarie
VILLE Montréal
INVESTIGATEUR(RICE) PRINCIPAL(E) Kevin Petrecca
COORDONATEUR(RICE) Gabriele Riva
gabriele.riva@mcgill.ca
514-398-6907
STATUT  Fermé
CRITÈRES D'ÉLIGIBILITÉ (EN)
  1. Age ≥18 and ≤ 70 years (≤ 75 years after amendement 3)
  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 < 1 times ULN

    Renal Function:

    • Serum Creatinine ≤ 1.5 times ULN

    Inclusion Criteria Related to Surgery:

  8. IORT must be technically feasible
  9. Histologically confirmed (frozen section) GBM (WHO grade IV)
CRITÈRES D'EXCLUSION (EN)
  • 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