Clinical trial NCT01811121: MEDICO-ECONOMIC EVALUATION OF SURGERY GUIDED BY FLUORESCENCE FOR THE OPTIMIZATION OF RESECTION OF GLIOBLASTOMAS
Official title: Randomized, Prospective, Multicenter Blinding Singles With Arm A and Arm B Innovative Strategy Strategy Conventional
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Glioblastoma
Keywords: Glioblastoma
5ALA
fluorescence
resection
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2013-03-14
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 surgical excision as complete as possible followed by an additional radiochemotherapy. The prognosis depends mainly on the quality of resection when it is macroscopically complete. Different techniques to support the surgical resection have been developed over the past 20 years. The reference technique is currently the intraoperative neuronavigation for guiding excision by matching the intraoperative tumor boundaries with those of the preoperative MRI. Its main drawback is the loss of precision during the resection related to changes in anatomical limits of the tumor.

The per-operative fluorescence-guided surgery (FGS) is an innovative alternative technique to support the surgical resection. The 5-aminolevulinic acid (5-ALA), a molecule absorbed by the patient before surgery is captured specifically by the tumor cells and transformed into a fluorochrome revealed intraoperatively by a light source length adapted wave with a set of lenses included in the microscope. Resection is thus guided by this fluorescence whose disappearance translates complete tumor resection.

Its interest is twofold:

* Increase the percentage of complete tumor resection.
* Improve disease-free survival and overall survival. The objective of the study is to compare the FGS to the intraoperative neuronavigation for the resection of glioblastoma, on a medical and economical level through a randomized, prospective, multicenter trial.

The annual number of patients likely to benefit of this technique in France is estimated at 2200 new cases.

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 committee of independent reading with qualitative analysis taking a contrast replay console for diagnostic use

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: Comparison of complete tumor resection between the 2 arms
timeFrame: 48 hours
Secondary outcomes:
measure: Comparison of complete tumor resection between the 2 arms
timeFrame: less than 48 hours after surgery
Other outcomes:
measure: Diagnostic value of the two intraoperative techniques
timeFrame: 60 months
measure: Quantification of residual tumor (contrast enhancement) on MRI post-opératre early (before 48 hours)
timeFrame: before 48 hours
measure: Progression Free survival rate at 6 months
timeFrame: 6 months
measure: Overall survival at 24 months
timeFrame: 24 months
measure: Overall survival at 60 months
timeFrame: 60 months
measure: Quality of life
timeFrame: every 3 months
measure: Evaluation of early and late morbidity
timeFrame: in 8 days and late morbidity at 3 months
measure: Comparison of surgical procedure duration between the 2 arms
timeFrame: 60 months
measure: Medico-economic evaluation of the 2 procedure
timeFrame: 60 months
Locations:
city: Lyon
country: France
facility: Guyotat
Study officials:
affiliation: Hospices Civils de Lyon
name: Jacques GUYOTAT, MD
role: STUDY_DIRECTOR
References: