Status:
COMPLETED
MEDICO-ECONOMIC EVALUATION OF SURGERY GUIDED BY FLUORESCENCE FOR THE OPTIMIZATION OF RESECTION OF GLIOBLASTOMAS
Lead Sponsor:
Hospices Civils de Lyon
Conditions:
Glioblastoma
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Glioblastoma is the most frequent primary malignant brain tumor in adults (3,000 new cases per year) and is characterized by a poor prognosis (median survival 12 months). Treatment is based mainly on ...
Detailed Description
Main Outcome Measure: 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 a central co...
Eligibility Criteria
Inclusion
- Age greater than 18 years with no upper age limit
- Competent adult patient.
- Patient affiliated to the National Health Insurance.
- Patient with an intra-cerebral supra-tentorial hemispheric, newly diagnosed and previously untreated, which MRI characteristics are suggestive of a glioblastoma.
- Indication for surgical treatment by excision.
- Brain tumor location distant from critical functional areas allowing a wide resection of contrast enhancement on imaging, the a priori character completely resectable has been validated by an evaluation committee composed of three surgeons
- No-cons contain medical surgery, ASA score below 4.
- Patient eligible for further treatment by radiotherapy and concurrent chemotherapy followed by adjuvant chemotherapy according to the so called Stupp scheme (standard protocol of adjuvant chemoradiotherapy)
- Negative pregnancy test for women of childbearing age.
Exclusion
- Contraindications to performing an MRI (pacemaker).
- Glioblastoma known and previously treated with surgery, radiotherapy and / or chemotherapy.
- History of cancer.
- Anatomical Location of the tumor-cons indicating a wide excision, neurosurgeon at the discretion of medical officer participating center.
- Location tumor in the brain stem, the middle line, the basal ganglia and the posterior cranial fossa.
- Patient with cons-indication to the achievement of further treatment with radiotherapy and concurrent chemotherapy followed by adjuvant chemotherapy according to the scheme proposed by Stupp. (1)
- Patients with porphyria, renal insufficiency (creatinine\> 177 μmolL), liver insufficency(gamma glutamyl transpeptidase\> 100 U / L, prothrombin time \<60%, bilirubin\> 51μmol / L).
- Patient refused to sign an informed consent form.
- Ongoing participation of the patient to another clinical trial.
Key Trial Info
Start Date :
February 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2019
Estimated Enrollment :
170 Patients enrolled
Trial Details
Trial ID
NCT01811121
Start Date
February 1 2013
End Date
August 1 2019
Last Update
September 15 2025
Active Locations (1)
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1
Guyotat
Lyon, France