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Randomized, Prospective, Multicenter Blinding Singles With Arm A and Arm B Innovative Strategy Strategy Conventional


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Glioblastoma

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Trial Information

Randomized, Prospective, Multicenter Blinding Singles With Arm A and Arm B Innovative Strategy Strategy Conventional


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


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Outcome Measure:

Comparison of complete tumor resection between the 2 arms

Outcome Description:

Evidenced of complete resection (absence of residual tumor on early postoperative MRI (within 48 hours)) will be assessed by a central independent committee with qualitative analysis of contrast enhancement replay on a console for diagnostic use.

Outcome Time Frame:

48 hours

Safety Issue:

No

Principal Investigator

Jacques GUYOTAT, MD

Investigator Role:

Study Director

Investigator Affiliation:

Hospices Civils de Lyon

Authority:

France: Agence Nationale de Sécurité du Médicament et des produits de santé

Study ID:

2011-697

NCT ID:

NCT01811121

Start Date:

February 2013

Completion Date:

August 2019

Related Keywords:

  • Glioblastoma
  • Glioblastoma
  • 5ALA
  • fluorescence
  • resection
  • Glioblastoma

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