| Titre |
A Multicenter Randomized Phase III Trial on INTraoperative RAdiotherapy in Newly Diagnosed GliOblastoma Multiforme |
| Protocole ID |
INTRAGO II |
| ClinicalTrials.gov ID |
NCT02685605 |
| Type(s) de cancer |
Cerveau (SNC) |
| Phase |
Phase III |
| Type étude |
Traitement |
| Institution |
CENTRE UNIVERSITAIRE DE SANTE MCGILL
 HOPITAL NEUROLOGIQUE DE MONTREAL
3801 Rue Université, Montréal, QC, H3A 2B4
|
| Ville |
Montréal |
| Investigateur(trice) principal(e) |
Dr Kevin Petrecca
|
| Coordonnateur(trice) |
Gabriele Riva
514-398-6907
|
| Statut |
 Actif en recrutement |
| Critètes d'éligibilité |
- Age ≥18 and ≤ 70 years (≤ 75 years after amendement 3)
- 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 informed consent obtained at least 24h prior to surgery
- For women with childbearing potential: adequate contraception
-
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:
- IORT must be technically feasible
- Histologically confirmed (frozen section) GBM (WHO grade IV)
|
| Critètes d'exclusion |
- 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
|
Groupe d'étude en oncologie du Québec