Glioblastoma MedDRA version: 19.1 Level: PT Classification code 10018336 Term: Glioblastoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: GLIOLAN
Pharmaceutical Form: Powder for oral solution
INN or Proposed INN: AMINOLEVULINIC ACID HYDROCHLORIDE
CAS Number: 5451-09-2
Sponsors
Hospics Civils de Lyon
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Pre inclusion criteria : -Age greater than 18 years. -Maggiore unprotected. -Patient-affiliated to a National Health Insurance. -Patient with intracerebral tumor, supra-tentorial hemispheric newly diagnosed and untreated previously, the MRI features suggestive of a glioblastoma. -Indication to surgical treatment by excision. -Against-No medical indication for surgery, ASA score less than 4. -Patient eligible for further treatment with radiotherapy and concurrent chemotherapy and adjuvant chemotherapy according to the scheme proposed by Stupp. (1) For patients older than 70 years, Stupp protocol, radiotherapy alone or chemotherapy will be administered according to the recommendations of each center after reviewing the file in RCP -Negative pregnancy test for women of childbearing age Inclusion criteria : -Tumor location accessible to excision as complete as possible validated by pre operative evaluation by a committee of surgery outside the center inclusion (majority opinion favorable surgical taken on 3 reviews) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Non inclusion criteria : -Contraindications to performing an MRI (pacemaker). -hypersensitivity to 5-ALA or porphyrins, -Hypersensitivity to parahydroxybenzoate of méthyle or propyl - Renal lithiasis oxalate-calcium - Glioblastoma-known and previously treated with surgery, radiotherapy and / or chemotherapy. -History of cancer. -Location tumor in the brainstem, the midline, basal ganglia or posterior cranial fossa. -Patient with cons-indication to the achievement of further processing. (1) -Patient with porphyria, renal failure (creatinine> 177 µmolL), liver (gamma glutamyl transpeptidase> 100 U / L, prothrombin time 51µmol / L). -Patient refused to sign a consent form. -Participation in the course of the patient to another trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Percentage of patients with complete surgical excision of the brain tumor; Secondary Objective: - Diagnostic value of the two intraoperative techniques - Quantification of residual tumor (contrast enhancement) on MRI - Rate of recurrence-free survival at 6 months, - Rate of overall survival at 24 months, - Rate of overall survival at 60 months, - Evaluation of the quality of life every 3 months - Evaluation of early morbidity at 8 days and 3 months - Duration of the surgical procedure according to the technique used. - Calculation of cost-effectiveness ratio difference between the two strategies. ; Primary end point(s): Percentage of patients with surgical resection of the tumor is complete, objectified by the absence of residual tumor on MRI early postoperative (within 48 hours) by the neurosurgeon who performed the surgical procedure and the neuro-radiologist who MRI performed with qualitative analysis of contrast enhancement during the initial clinical analysis. This double reading (Independent Committee and neurosurgeon and neuroradiologist at each center) will assess the reliability of interpretations of postoperative imaging. ;Timepoint(s) of evaluation of this end point: two days | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Clinic : 1-Quantification of relict tumor by an independent expert committee. 2-Values ??of the diagnostic quality of resection of both techniques intraoperative evaluated by calculating the sensitivity, specificity, positive predictive value and negative, the gold standard is defined by the presence or absence of tumor tissue and / or tumor infiltration of the samples performed on the banks of resection (limits anterior, posterior, external, internal, deep anterior and posterior deep) and performed in the usual manner after surgery. 3-Rate of recurrence-free survival at 6 months, recurrence is defined by the appearance of a new tumor lesion with minimal volume is set to 0.175 cm3 by increasing the volume of residual tumor 25% or more by need to increase the steroids 4-Rate of overall survival at 24 months, measured from the number of patients who died whatever the cause 5-Rate of overall survival at 60 months, estimated from the number of patients dying whatever the cause 6-Evaluation of quality of life before resection and at 3, 6, 9, 12, 15, 18 and 24 months after surgical excision using the questionnaire EORTC QLQ-C30 with the module BN20, specific brain tumors 7-Evaluation of early morbidity in 8 days and 3 months late morbidity 8-Duration of the surgical procedure according to the technique used. Economic : compare the two dimensions of efficacy outcomes and costs of both strategies supported glioblastomas ;Timepoint(s) of evaluation of this end point: 60 months | — |
Countries
France
Contacts
Public ContactZUBLENA
HOSPICES CIVILS DE LYON
Outcome results
None listed